Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
Conditions: Cerebrospinal; Disorder
Sponsor: Integra LifeSciences Corporation

 
 
C-EXTVDR-001 
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POST-MARKET CLINICAL FOLLOW-UP REGISTRY OF THE INTEGRA EXTERNAL 
VENTRICULAR DRAINAGE SYSTEMS AND ACCESSORIES 
 
 
Short Title: External Ventricular Drainage PMCF Registry 
Protocol Number: C-EXTVDR-001 
National Clinical Trial (NCT) Identified Number: NCT05652296 
 
Protocol Version: V5.0 
 
Protocol Date: 11-JUL-2024 
 
Sponsor and Manufacturer: 
Integra LifeSciences 
1100 Campus Drive, Princeton, New Jersey, 08540 
 
European Representative: Integra LifeSciences Services (France) S.A.S. 
Immeuble Séquoia 2 
97 Allée Alexandre Borodine 
69800 Saint Priest 
FRANCE 
www.integralife.com  
 
 

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Table of Contents 
A. 
AUTHORIZED SIGNATORIES FOR THE SPONSOR .......................................................................... 7 
B. 
MEDICAL EXPERT FOR THE STUDY ............................................................................................... 7 
C. 
STUDY INVESTIGATORS AND SITE MEDICAL STAFF ...................................................................... 8 
D. 
INVESTIGATION FUNDING AND INVESTIGATOR AGREEMENT OVERVIEW .................................. 8 
E. 
CLINICAL LABORATORIES AND CONTRACT RESEARCH ORGANISATIONS .................................... 8 
STATEMENT OF COMPLIANCE BY THE INVESTIGATOR ............................................................................ 9 
1. 
PROTOCOL SUMMARY ............................................................................................................... 10 
1.1 
Protocol Synopsis ................................................................................................................... 10 
1.2 
Data Collection Scheme ......................................................................................................... 17 
1.3 
Schedule of Activities ............................................................................................................. 18 
2 
INTRODUCTION .......................................................................................................................... 19 
2.1 
Background ............................................................................................................................ 19 
2.2 
Device Overview and Use ...................................................................................................... 19 
2.2.1 
Cranial Access ................................................................................................................. 19 
2.2.2 
EVD Systems ................................................................................................................... 21 
2.2.3 
Catheters ........................................................................................................................ 28 
2.2.4 
EVD Accessories ............................................................................................................. 30 
2.2.5 
Contraindications ........................................................................................................... 30 
2.3 
Intended Purpose in the post-market clinical follow-up registry .......................................... 30 
2.4 
Required training and experience .......................................................................................... 30 
2.5 
Device Accountability ............................................................................................................. 31 
2.6 
Device Traceability ................................................................................................................. 31 
3 
OBJECTIVES AND ENDPOINTS .................................................................................................... 31 
3.1 
Primary Objective ................................................................................................................... 31 
3.2 
Safety Objective ..................................................................................................................... 31 
3.3 
Primary Endpoint ................................................................................................................... 31 
3.4 
Secondary Endpoint ............................................................................................................... 31 
3.5 
Tertiary Endpoints .................................................................................................................. 31 
3.6 
Safety Endpoints .................................................................................................................... 32 

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4 
RISKS AND BENEFITS OF THE REGISTRY STUDY .......................................................................... 33 
4.1 
Anticipated Clinical and Device Benefits ................................................................................ 33 
4.2 
Anticipated Adverse Device Effects/Residual Risks ............................................................... 33 
4.3 
Risks Associated with Participation in the Registry study ...................................................... 33 
4.4 
Risk Control/Mitigation .......................................................................................................... 33 
4.5 
Risk/Benefit Analysis .............................................................................................................. 33 
5 
STUDY DESIGN ............................................................................................................................ 34 
5.1 
Overall Design ........................................................................................................................ 34 
5.2 
Description of Sites ................................................................................................................ 34 
5.3 
Rationale for Study Design ..................................................................................................... 34 
5.4 
End of Study Definition Overview .......................................................................................... 34 
5.5 
Primary Study Hypothesis ...................................................................................................... 34 
6 
STUDY POPULATION .................................................................................................................. 35 
6.1 
Inclusion Criteria .................................................................................................................... 35 
6.2 
Exclusion Criteria .................................................................................................................... 35 
6.3 
Point of Enrollment & Enrollment Period .............................................................................. 35 
6.4 
Comparison of Study Population to Target Population ......................................................... 36 
6.5 
Screen Failures and Failures ................................................................................................... 36 
7 
STUDY INTERVENTION/INVESTIGATIONAL PRODUCT ............................................................... 36 
8 
STUDY ASSESSMENTS AND PROCEDURES .................................................................................. 36 
8.1 
Informed Consent .................................................................................................................. 36 
8.2 
Performance Data to be Collected ......................................................................................... 37 
8.3 
Safety and Other Assessments ............................................................................................... 37 
8.4 
Concomitant Medication Review ........................................................................................... 38 
9 
SAFETY ........................................................................................................................................ 38 
9.1 
Definitions .............................................................................................................................. 38 
9.1.1 
Adverse Device Effect (ADE) .......................................................................................... 38 
9.1.2 
Adverse Events (AE) ....................................................................................................... 38 
9.1.3 
Device deficiency............................................................................................................ 39 
9.1.4 
Incident .......................................................................................................................... 39 

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9.1.5 
Malfunction .................................................................................................................... 39 
9.1.6 
Serious Adverse Device effect (SADE) ............................................................................ 39 
9.1.7 
Serious Adverse Events (SAE) ......................................................................................... 39 
9.1.8 
Unanticipated Serious Adverse Device effect (USADE) ................................................. 39 
9.1.9 
Unanticipated Serious Incident ...................................................................................... 40 
9.2 
Classification .......................................................................................................................... 40 
9.3 
Relationship to Study Intervention ........................................................................................ 40 
9.4 
Expectedness.......................................................................................................................... 43 
9.4.1 
Anticipated Adverse Device Effects ............................................................................... 43 
9.5 
Adverse Event Coding ............................................................................................................ 44 
9.6 
Time Period and Frequency for Event Assessment and Follow-Up ....................................... 44 
9.7 
Event Reporting ...................................................................................................................... 45 
9.7.1 
Event Reporting to Regulatory Authorities .................................................................... 45 
9.7.2 
Reporting to Ethics Committees .................................................................................... 45 
9.7.3 
Reporting of Device Deficiencies (DDs) .......................................................................... 46 
10 
PATIENT DISCONTINUATION OF CONSENT FOR THE STUDY ..................................................... 47 
11 
STATISTICAL CONSIDERATIONS .................................................................................................. 48 
11.1 
Statistical Hypotheses ............................................................................................................ 48 
11.2 
Sample Size Determinations .................................................................................................. 48 
11.3 
Populations for Analyses ........................................................................................................ 48 
11.4 
Statistical Analyses ................................................................................................................. 49 
11.4.1 
General Approach .......................................................................................................... 49 
11.4.2 
Measures to Minimize Bias ............................................................................................ 49 
11.4.3 
Analysis of the Primary Endpoint ................................................................................... 49 
11.4.4 
Analysis of the Secondary Endpoint ............................................................................... 50 
11.4.5 
Analysis of the Tertiary Endpoints ................................................................................. 50 
11.4.6 
Safety Analyses .............................................................................................................. 50 
11.4.7 
Baseline Descriptive Statistics ........................................................................................ 51 
11.4.8 
Planned Interim Analysis ................................................................................................ 51 

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11.4.9 
Sub-Group Analyses ....................................................................................................... 51 
11.4.10 
Tabulation of Individual Participant Data ...................................................................... 51 
11.4.11 
Exploratory Analyses ...................................................................................................... 51 
11.4.12 
Missing Data ................................................................................................................... 52 
12 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ................................. 52 
12.1 
Regulatory, Ethical, and Study Oversight Considerations ...................................................... 52 
12.1.1 
Informed Consent Process ............................................................................................. 52 
12.1.2 
Study Discontinuations and Closure .............................................................................. 53 
12.1.3 
Confidentiality and Privacy ............................................................................................ 54 
12.1.4 
Future Use of Stored Data.............................................................................................. 54 
12.1.5 
Site Selection, Corrective and Preventative Actions, Investigator Disqualification ....... 55 
12.1.6 
Clinical Monitoring ......................................................................................................... 55 
12.1.7 
Quality Assurance and Quality Control .......................................................................... 55 
12.1.8 
Data Handling and Record Keeping................................................................................ 56 
12.1.9 
Protocol Deviations ........................................................................................................ 57 
12.1.10 
Publications and Data Sharing Policy ............................................................................. 58 
12.1.11 
Conflict of Interest Policy ............................................................................................... 58 
12.2 
Abbreviations ......................................................................................................................... 59 
12.3 
Protocol Amendment History ................................................................................................ 60 
13 
REFERENCES ............................................................................................................................... 61 
14 
APPENDIX I ................................................................................................................................. 62 
14.1 
External Ventricular Drainage Systems included in this registry study ................................. 62 
14.2 
External Ventricular Drainage Catheters included in this registry study ............................... 62 
14.3 
Cranial Access included in this registry study ........................................................................ 62 
14.4 
External Ventricular Drainage Accessories included in this registry study ............................ 63 
 
 
 
 

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LIST OF FIGURES 
Figure 1. Enrollment Flowchart .............................................................................................................. 17 
Figure 2. Codman Cranial Access Kits .................................................................................................... 20 
Figure 3. The LimiTorrTM ......................................................................................................................... 21 
Figure 4. MoniTorr™ ICP External CSF Drainage and Monitoring Systems ............................................ 22 
Figure 5. AccuDrain® System Components ............................................................................................ 23 
Figure 6. Hermetic Plus System Components ........................................................................................ 24 
Figure 7. Codman® EDS 3TM CSF External Drainage System ................................................................. 25 
Figure 8. Ventricular Drainage Systems ................................................................................................. 26 
Figure 9. CSF Drainage System Components with large bore blue striped tubing assembly ................ 27 
Figure 10. Hermetic External CSF Drainage System Components with pressure tubing ....................... 27 
Figure 11. The Codman Bactiseal EVD Catheter .................................................................................... 28 
Figure 12. External Ventricular Drainage Catheters .............................................................................. 29 
Figure 13. Pole Mount Assembly ........................................................................................................... 30 
Figure 14. Expectedness determination of investigational device or procedure related AEs ............... 43 
 
LIST OF TABLES 
Table 1. Schedule of Activities ............................................................................................................... 18 
 
 
 

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A. AUTHORIZED SIGNATORIES FOR THE SPONSOR 
Name 
Position/Title 
Signature/Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
B. MEDICAL EXPERT FOR THE STUDY 
 
Jason M. Marzuola, MSN RN CNRN 
Director, Global Medical Affairs  
Phone : +1 609-433-1492 
e-mail : jason.marzuola@integralife.com  

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C. STUDY INVESTIGATORS AND SITE MEDICAL STAFF 
The contact information of all sites, study investigators and other site medical experts (if applicable) 
involved in conducting the registry study, can be found in the Trial Master File (TMF). 
D. INVESTIGATION FUNDING AND INVESTIGATOR AGREEMENT OVERVIEW 
This protocol is being funded by Integra Lifesciences, Corp. All lead investigators at study sites will 
become signatories on a study-specific Clinical Trial Agreement (CTA) which details the legal and 
regulatory roles and responsibilities of the Sponsor, investigator, and study site in carrying out the 
protocol. 
E. CLINICAL LABORATORIES AND CONTRACT RESEARCH ORGANISATIONS 
The list of laboratories and/or contract research organizations (CROs), if applicable, can be found in 
the TMF. 
 
 

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STATEMENT OF COMPLIANCE BY THE INVESTIGATOR 
 
By signing this document, I, the Investigator, certify that this registry study will be carried out in 
accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, and the following:  
 
• 
Applicable laws and regulations as laid out by the European Union (EU) and/or by individual 
countries 
 
AND, where applicable, 
 
• 
EU 2017/745 (Medical Device Regulation) 
• 
ISO 14155:2020 
 
Additionally, I and any registry study site staff who are responsible for the conduct, management, or 
oversight of this registry study will complete Human Subjects Protection/ GCP Training. 
 
The protocol, informed consent form(s), any recruitment materials, and/or all participant materials 
associated with this registry study will be submitted to an Ethics Committee (EC) for review and 
approval. Approval of both the protocol and the consent form must be obtained before any participant 
is enrolled.   
 
Finally, I understand that any amendments to the protocol or consent forms will require review and 
approval by the EC before the changes are implemented to the study. 
 
 
 
Investigator Name 
 
 
 
Investigator Signature  
Date 

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1. PROTOCOL SUMMARY 
1.1 Protocol Synopsis 
Title: 
Post-Market Clinical Follow-Up Registry of the Integra External 
Ventricular Drainage Systems and Accessories 
Short Title: 
External Ventricular Drainage PMCF Registry 
Protocol number: 
C-EXTVDR-001 
Study Description: 
This post-market follow-up registry will capture clinical data specific to 
the safety and performance of the Integra External Ventricular Drainage 
Systems and Accessories. 
Background: 
External Ventricular Drainage (EVD) Systems are a temporary system 
which allow drainage of cerebrospinal fluid (CSF) from the lateral 
ventricles of the brain. EVD Systems are commonly used within 
neurosurgery for the management of patients who require drainage of 
CSF. 
EVD Systems are regularly used in neurosurgery for diagnostic and 
therapeutic purposes. 
Complications of EVD Systems are well recognized, with infection and 
hemorrhage being the most common ones related to these procedures, 
followed by ventriculostomy occlusion. 
The rate of EVD-associated hemorrhage ranges from 18 to 41% in adults 
as reported in literature, and in pediatric population (single center), it 
has been found that incidence of hemorrhage at EVD placement to be 
10%, and the incidence of hemorrhage on EVD removal to be 21.9%. 
Studies have demonstrated non patent EVDs in 19-47% of patients. 
Pre/Post-Market: 
Post-Market Clinical Follow-Up Registry 
Study Design: 
Observational, multi-center, post-market registry 
Primary Objective: 
The primary objective of this registry is to capture clinical performance 
data to confirm the continued performance of the Integra External 
Ventricular Drainage Systems and Accessories. 
Safety Objective:  
The safety objective of this registry is to capture clinical safety data to 
confirm the continued safety of the External Ventricular Drainage 
Systems and Accessories. 
Primary Endpoint: 
The primary endpoint is anticipated drainage (i.e., observed drainage 
consistent with the patient’s clinical presentation) of cerebrospinal 
fluid (CSF) in the clinical setting until the EVD System is no longer 
required.  
 

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Note: Excessive drainage (e.g., more than 25 cc every hour) not 
attributable to the patient’s condition, widely variable drainage over 
time inconsistent with the patient’s clinical presentation, drainage 
levels inconsistent with concurrent neurological exams (e.g., GCS, 
NIHSS, etc.), and/or documented device deficiencies impacting 
drainage (e.g., breakage disconnection, etc.) are examples of 
unanticipated drainage of CSF that will be recorded as Adverse Events.  
Secondary Endpoint 
The secondary endpoint is the proportion of patients in whom the 
CODMAN Cranial Access Kit, when used with appropriate accessories, 
provided successful access to the intracranial space. 
Tertiary Endpoints: 
• 
Number of initial Catheter Insertion Attempts [Time Frame: 
Implantation of subject] Number of insertions needed to place 
initial Catheter 
• 
Number of days initial Catheter is in place.  
• 
Number of Catheter and/or EVD System replacements during 
treatment, if applicable. 
• 
Number of Catheter flushing interventions per each Catheter if 
a replacement Catheter is implanted. 
• 
Length of Catheter Tunneling into the Brain [Time Frame: 
Implant of subject] Length of tunneling of EVD Catheter in the 
brain for each analysis population.  
• 
Number of Days with initial Indwelling Catheter [Time Frame: 
Implant of subjects to the day of explant] Days Catheter was 
implanted in subjects 
• 
Non-infectious Catheter Failure in the intent-to-treat (ITT) 
Population [Time Frame: Implant of subject to explant] Reasons 
for non-infectious Catheter malfunctions in the ITT population. 
• 
CSF daily drainage  
   Safety Endpoints: 
1. Device- or procedure-related adverse events (AEs) during the use of 
the device in the patient 
2. Noted Device Deficiencies during use of the device such as 
malfunction, use errors, or other issues related to the performance 
or safety of the External Ventricular Drainage Systems and Accessories 
Sample 
Size 
and 
Enrollment: 
Approximately 120 patients at up to 15 study sites.  Inclusion will be 
halted at sites that reach the 34% (40 subjects) inclusion cap. There will 
be no minimum number of subjects for a single study site. 
Device Identification: 
All active External Ventricular Drainage Systems and accessories under 
the following product families will be included in the registry.  
EVD Systems*: 
• 
AccuDrain 

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• 
Hermetic Plus 
• 
LimiTorr  
• 
MoniTorr 
• 
Codman EDS 3 / EDS 3C 
• 
Basic CSF Drainage System 
• 
External Ventricular Drainage System 
EVD Catheters *: 
• 
TraumaCath Ventricular Catheter Set 
• 
Hermetic Ventricular Catheter 
• 
Bactiseal Anti-Microbial Catheter 
Note: in this study, EVD Catheters will be considered as accessories to 
the EVD Systems. 
 
EVD Accessories * 
 
Cranial Access*: 
• 
CODMAN Cranial Access Kit 
*Refer to APPENDIX I at the end of the protocol for product-specific 
Stock Keeping Units (SKUs) to be included in this post-market registry. 
 
Indications for Use 
EVD Systems: 
The AccuDrain is indicated for draining and monitoring of CSF flow from 
the ventricles of the brain or lumbar subarachnoid space in selected 
patients to reduce Intracranial Pressure (ICP), to monitor ICP, to monitor 
CSF, and to provide temporary CSF drainage. 
 
The Hermetic Plus is indicated for draining and monitoring of CSF flow 
from the lateral ventricles of the brain or lumbar subarachnoid space in 
selected patients to reduce Intracranial Pressure (ICP), to monitor ICP, 
to monitor CSF, and to provide temporary CSF drainage for patients with 
infected hydrocephalic shunts. 
 
The LimiTorr and MoniTorr System allow for drainage and monitoring of 
CSF from the lateral ventricles of the brain or lumbar subarachnoid space 
in selected patients to reduce ICP, to monitor CSF, to provide temporary 
drainage of CSF in patients with infected CSF shunts, and to monitor ICP. 
 
The Codman External Drainage Ventricular System is indicated for 
draining CSF from the cerebral ventricles or the lumbar subarachnoid 

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space as a means of reducing intracranial pressure and CSF volume when 
the insertion of a permanent, internal shunt is not indicated. 
 
Catheters: 
TraumaCath and Hermetic Ventricular Catheters are indicated for 
drainage and monitoring of CSF from the lateral ventricles of the brain. 
The catheters may be used to reduce ICP, to monitor ICP, to monitor CSF, 
and in the management of hydrocephalic shunt infections. 
 
The Codman Bactiseal EVD Catheter and Codman Bactiseal Clear EVD 
Catheter Sets (Bactiseal EVD Catheters), are indicated for gaining access 
to the ventricles of the brain and can be used with dimensionally 
compatible devices for draining CSF and other fluids of similar physical 
characteristics as a means of reducing intracranial pressure (ICP) and CSF 
volume.  
 
CRAK: 
The Cranial Access Kits (CRAKs, Figure 2) allows for access to the 
subarachnoid space or the lateral ventricles of the brain. The kit is 
intended to be used with an external drainage and monitoring system in 
selected patients to reduce ICP, to monitor CSF, to provide temporary 
drainage of CSF, and to monitor ICP.  
 
The Ventricular and Integral External Drainage Sets (EDS) and 
Accessories are intended for CSF drainage, sampling, and collection. The 
EDS is intended to be connected to a ventricular or a lumbar catheter.  
 
Note: For the purposes of this study, only the ventricular use will be the 
focus. 
Refer to Section 2.2 for further information of all indications for use. 
Study Design Rationale: 
The purpose of this study is to investigate whether the Integra External 
Ventricular Drainage Systems listed as part of this study do perform to 
clinical expectations. 
Additionally, this study will focus on the safety of these devices by 
collecting any device-specific Adverse Events (AEs) or Device 
deficiencies (DDs) seen when used during standard of care procedures. 
 
A registry is the most appropriate design for a study such as this 
because registries proactively collect study data, but do not needlessly 
expose patients to non-standard of care interventions or procedures. 

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Additionally, registries include data from patients with complex medical 
histories which will generally provide more real-world evidence. 
 
Including multiple centers and nations will ensure that data collected is 
from a broad set of surgeons and countries, thereby increasing the 
generalizability of the outcomes and conclusions. 
 
Study outcomes will be summarized using descriptive statistics. 
Categorical variables will be summarized using frequencies and 
percentages. Continuous variables will be summarized using means, 
standard deviations, medians, ranges, and numbers of observations. 
 
A sample size of 120 patients will be enrolled with 8% potential drop-
out assumed.  
Integra LifeSciences Corporation believes this study design and sample 
size is appropriate to confirm the continued safety and performance of 
these devices given their well-established nature and the existing clinical 
evidence base. 
Description of 
Intervention: 
Not applicable – This is a non-interventional, observational registry. 
Instead, data will be collected on the following devices following 
routine/standard of care use and in accordance with the Instructions for 
Use (IFU). 
Study Population: 
Consecutive patients of any age, and gender who underwent a 
procedure with one of the Integra External Ventricular Drainage Systems 
or Accessories. 
Inclusion Criteria 
1. Patient and/or legally authorized representative has agreed to 
participate in the study by signing the EC-approved consent form, 
where applicable. 
2. Patients (of any age) who underwent or who plan to have a 
procedure with one of the Integra or Codman External Ventricular 
Drainage System. 
3. For patients who have had the EVD System removed prior to study 
enrollment, have available follow-up data from implant until the 
EVD System is no longer required for drainage and monitoring of 
CSF. 
Exclusion Criteria 
1. The Patients in whom more than one EVD System were or are 
intended to be placed. 
2. The Patient has sepsis. 
3. The Patient has a history of poor wound healing. 
4. The patient exhibits signs of scalp infection prior to implantation 
that would be contraindicated per the IFU. 

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5. The Patient is otherwise determined by the Investigator to be 
medically unsuitable for participation in this Registry. 
6. The Patient is currently enrolled in another device trial or has been 
previously entered in this trial. 
7. The Patient is a prisoner or member of a different vulnerable 
population that should not be included in the study per the 
investigator. 
8. The Patients known to have uncorrected coagulopathy. 
9. The Patients with known hypersensitivity to rifampin or clindamycin 
hydrochloride (prior to implantation of Bactiseal catheters) 
 Registry Study Site & 
Investigator Selection: 
Up to 15 sites in EU countries, UK and Switzerland will participate in this 
study. Sites will be chosen based upon their experience with the EVD 
System and accessories and their ability to fulfill general requirements 
in Sponsor’s Standard Operating Procedures (SOPs). 
Study Duration: 
Total duration of data collection is expected not to exceed 25 months at 
any individual site. The number of sites postulated are sufficient to 
ensure adequate data collection within the stated timeframe. 
Patient Duration: 
This registry will collect data on patients from implant of the EVD System 
and accessories until the EVD System is no longer required for drainage 
and monitoring of CSF.  
Study Visits:  
• 
 Not applicable – There are no study visits in this protocol for 
patients to attend. 
Data for Collection: 
The following data will be collected:  
Patient Data: 
• 
Basic demographic data (e.g., gender, age) 
• 
Clinical diagnosis for requiring an External Ventricular Drain. 
Device Related Data: 
• 
EVD system and accessories information. 
• 
Details of EVD system and Catheter replacement(s), if 
applicable.  
Clinical Performance– in accordance with the primary, secondary and 
tertiary endpoints: 
• 
CSF drainage (daily total) 
• 
Intracranial access location 
• 
EVD system and accessories maintenance procedures 
• 
Number, type, and volume of flush(s) used to address 
occlusions, if applicable. 
• 
Concomitant neurosurgical and neuro-interventional 
procedures  
• 
Relevant concomitant medications 
Safety Data – in accordance with the safety endpoints: 

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• 
EVD system and accessories or procedure related AEs 
• 
Noted device deficiencies during use of the EVD system and 
accessories 
Statistical Methods & 
Analyses: 
Study outcomes will be summarized using descriptive statistics. 
Categorical variables will be summarized using frequencies and 
percentages. Continuous variables will be summarized using means, 
standard deviations, medians, ranges, and numbers of observations. 
The primary endpoint of success rate will be evaluated against a pre-
defined performance goal of 80%. The sample size of 120 patients will 
provide greater than 80% power to test the hypothesis. A P-value of less 
than 0.05 is considered statistically significant unless otherwise 
specified. The secondary endpoint will be summarized descriptively. 
Subgroup analyses will be performed for drainage systems. Descriptive 
statistics will be provided for the sub-groups. 
Reference: 
Integra’s and Codman’s External Ventricular Drainage Systems have 
been on the market for at least 15 years and to date, do not have any 
unanswered questions on safety or performance. Evidence from peer-
reviewed literature has confirmed that these products are safe and 
perform as intended. The registry design was therefore chosen to 
capture real-world experience with device use. Integra believes this 
study design and size is appropriate to confirm the continued safety and 
performance of these devices given their well-established nature and 
the existing clinical evidence-base. 

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1.2 Data Collection Scheme 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Enrollment Flowchart 
 
Patient treated or planned to be treated 
with one of the Integra or Codman 
External Ventricular Drainage Systems 
Data from patient 
meets eligibility 
criteria? 
Yes 
No 
Exclude 
record 
Has study-wide enrollment been met? 
Include 
record 
Stop 
Yes 
No 

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1.3 Schedule of Activities 
Table 1. Schedule of Activities1 
Procedures 
Study Assessments 
Informed consent2 
X 
Demographics/Patient data 
X 
EVD System and Accessories information/Details of Catheter and/or EVD 
System replacement(s), if applicable/Procedural data 
X 
Clinical Performance Data: 
• 
Cerebrospinal fluid drainage (daily drainage) 
• 
Intracranial access location  
• 
EVD system and accessories maintenance procedures 
• 
Number, type, and volume of flush(s) used to address occlusions, if 
applicable 
• 
Concomitant neuro-surgical and neuro-interventional procedures 
• 
Relevant concomitant medications 
X 
Safety Data: 
• 
EVD system and accessories or procedure related AEs 
• 
Noted Device Deficiencies during use of the EVD system and 
accessories 
X 
 
 
 
 
 
 
 
 
 
 
1 Details about all activities can be found in Section 8, unless otherwise specified. 
 
2 Informed consent is captured once, prior or after implantation of the EVD System. 

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2 INTRODUCTION 
2.1 Background 
The intracranial space is a fixed volume construct; the brain tissue, blood, and cerebrospinal fluid (CSF) 
are the components of this construct. Any change, therefore, in the volume of one of the components 
exerts deleterious pressure on the entire construct and stimulates compensatory measures to decrease 
the volume of the other components. This is the principle behind CSF drainage procedures conducted 
routinely in the neurocritical unit, often to reduce increased intracranial pressure (ICP) or intracranial 
hypertension. Conditions requiring CSF drainage may include hydrocephalus (a condition caused by excess 
buildup of CSF) and increased ICP following traumatic brain injury (TBI). CSF drains are also indicated for 
pre-and post-operative ICP monitoring in various cerebral conditions and in hydrocephalic shunt 
infections. 
CSF drainage can be performed on a permanent or a temporary basis. The permanent means of CSF 
drainage involves shunting excess CSF to areas within the body. External drainage methods are usually 
temporary measures that drain CSF outside the body into a receptacle. The external CSF drainage systems 
are either designed to drain CSF from the ventricles of the brain (external ventricular drainage, EVD) or 
from the subarachnoid space of the lumbar spine (external lumbar drainage), though for this study only 
the EVDs are used External ventricular CSF drainage is done either continuously or intermittently for ICP 
management [1].   
ICP monitoring is also routinely performed in the neurocritical unit either independently or in conjunction 
with CSF drainage. According to the Guidelines released by the Brain Trauma Foundation, ICP data can be 
used to predict outcomes and worsening intracranial pathology in severe TBI patients and are, therefore, 
useful in guiding therapy decisions [2, 3]. While ventricular ICP measurement is considered the reference 
standard, intraparenchymal, epidural, subdural, and subarachnoid spaces can also be used for effective 
ICP monitoring. 
The External Ventricular Drainage Systems involve the combined functioning of monitors, drainage sets, 
Catheters, and other accessories. The present study is meant to confirm the continued safety and 
performance of the External Ventricular Drainage Systems as distributed by Integra. The following 
sections detail the types of products to be studied and their use.  
2.2 Device Overview and Use 
The devices used in this study are detailed in the Appendix I at the end of the protocol and are as follows: 
2.2.1 Cranial Access 
 Codman Cranial Access Kits 
The Cranial Access Kits (CRAKs, Figure 2) allows for access to the subarachnoid space or the lateral 
ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in 
selected patients to reduce ICP, to monitor CSF, to provide temporary drainage of CSF, and to monitor 
ICP. 

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The CRAK Kit consists of various accessories used during a burr hole procedure. The main components of 
the kit include a hand drill with variable chuck, and a variety of drill bits with depth guard. The depth guard 
allows accurate, secure, and easy to use adjustment of hand drill depth. Hand drill depth is selected by 
setting the depth guard to the required distance. The kit also contains various accessory instruments, 
including scalpels, needles, razor, syringes, skin marker and ruler, fenestrated drape, towels, sponges, and 
gauze.  
 
 
Figure 2. Codman Cranial Access Kits 
 
 
 

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2.2.2 EVD Systems 
EVD Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the 
lumbar subarachnoid space in selected patients to reduce ICP, to monitor CSF, to provide temporary 
drainage of CSF in patients with CSF shunts infected or not, and to monitor ICP. For the purposes of this 
study, only the ventricular use will be the focus on patients without infected CSF shunt.  
Note: Although EVD Catheters are included as components in some EVD Systems in this study, EVD 
Catheters will be considered as accessories to the EVD Systems.  
 
 LimiTorr Volume Limiting External CSF Drainage and Monitoring System 
The LimiTorrTM Volume Limiting External CSF Drainage and Monitoring System (LimiTorr, Figure 3) 
provides a closed system for drainage of CSF from the ventricles of the brain to an external drainage bag. 
The LimiTorr was designed to include a volume limiting valve mechanism which reduces the chances for 
excessive CSF drainage. The burette in the LimiTorr contains a volume limiting valve which stops drainage 
when the pre-determined volume (20 ml or 30 ml) is reached. The system includes an antimicrobial 
hydrophobic vent. 
  
 
 
Figure 3. The LimiTorrTM 
 
 

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 MoniTorrTM 
The MoniTorr™ ICP External CSF Drainage and Monitoring Systems (Figure 4) includes MoniTorr CSF 
Drainage System with Patient Line One Way Valve (Product Code 10100), MoniTorr CSF Drainage System 
used with Pole Mount System (Product Code 10110 and INS1100), and MoniTorr CSF Drainage System 
Simple Bag and Line (Product Code 10150). The system may be used with a pole mounted assembly that 
allows for simple, quick, and accurate alignment with the patient and secure, positive or negative pressure 
level setting. The systems have also been designed to provide for ease of patient transport through a 
compact design and an antimicrobial hydrophobic vent feature that resists occlusion. 
 
 
Figure 4. MoniTorr™ ICP External CSF Drainage and Monitoring Systems 
 
 

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 AccuDrainTM External CSF Drainage System without or with the Anti-Reflux valve   
The AccuDrainTM External CSF Drainage System may be used without (Product Code INS8400) or with the 
Anti-Reflux valve (Product Code INS8401) (Figure 5). 
Monitoring of ICP is usually performed in selected patients with severe head injury, subarachnoid 
hemorrhage, Reyes syndrome or similar encephalopathies, hydrocephalus, hydrocephalic shunt 
infections, intracranial hemorrhage and pre and/or post-operative monitoring.  
 
Figure 5. AccuDrain® System Components 
 
 
 

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Hermetic PlusTM External CSF Drainage Systems with reflux valve 
The Hermetic Plus™ External CSF Drainage Systems with reflux valve (Product Code INS8301) (Figure 6) 
provide a sterile fluid path resistant to microbial particles and is a closed integral system.  
Monitoring of ICP is usually performed in selected patients with severe head injury, subarachnoid 
hemorrhage, Reyes syndrome or similar encephalopathies, hydrocephalus, intracranial hemorrhage, and 
under physician supervision and discretion when drainage is to be used as a therapeutic maneuver. 
Monitoring can also be used to evaluate the status pre-and postoperatively for space-occupying lesions. 
 
 
Figure 6. Hermetic Plus System Components 
 
 
 

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Codman® EDS 3TM CSF External Drainage System (EDS 3) without or with Ventricular 
Catheter 
Use of the Codman® EDS 3TM CSF External Drainage System (EDS 3) may be used without (Product Code 
821731 and 821731C) or with Ventricular Catheter (Product Code 821730C) (Figure 7). The system is 
indicated for draining CSF when the insertion of a permanent, internal shunt is not indicated  
 
Product Code 82-1731 
 
 
 
 
 
Product Code 82-1730C and 82-1731C  
 
Figure 7. Codman® EDS 3TM CSF External Drainage System 
 
 
 

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Ventricular Drainage Systems 
The Ventricular Drainage System Product Code NL850-500V (Figure 8), provides a sterile fluid path for the 
drainage of the CSF from an intraventricular Catheter to a collection bag. System components facilitate 
ventricular drainage, fluid injection, CSF sampling and ICP monitoring when used in conjunction with 
Camino® Ventricular Pressure Monitoring Kits. 
 
 
Figure 8. Ventricular Drainage Systems 
 
 
 

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External CSF Drainage Systems and Accessories 
The External CSF Drainage Systems and Accessories include the CSF Drainage System w/Blue Stripe Tubing 
& 1-way V (Product Code INS8600) (Figure 9) and the Hermetic External CSF Drainage System with 
pressure tubing (Product Code INS8601) (Figure 10) 
 
 
Figure 9. CSF Drainage System Components with large bore blue striped tubing assembly 
 
 
Figure 10. Hermetic External CSF Drainage System Components with pressure tubing 
 
 

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2.2.3 Catheters 
Acute hydrocephalus is one of the most common indications for EVD, whether due to subarachnoid 
hemorrhage, intraventricular hemorrhage, intraparenchymal hemorrhage, infection, brain tumors, or 
shunt failure. Additional indications for EVD include post hemorrhagic ventricular dilation and post 
hemorrhagic hydrocephalus in premature infants. The importance of CSF drainage, managed by EVD using 
ventricular drainage, is also included in the Brain Trauma Foundation Guidelines for the management of 
severe TBI [2]. While it is well recognized that EVD can be a life-saving intervention, EVD insertion is 
associated with a number of complications, including CSF infections, hemorrhage, and misplacement of 
the device [1, 4]. 
 Bactiseal External Ventricular Drainage Catheters 
The Codman Bactiseal EVD Catheter and Codman Bactiseal Clear EVD Catheter Sets (Bactiseal EVD 
Catheters), are indicated for gaining access to the ventricles of the brain and can be used with 
dimensionally compatible devices for draining CSF and other fluids of similar physical characteristics as a 
means of reducing intracranial pressure and CSF volume.  
Each of the Bactiseal EVD Catheters is a 35 cm silicone Catheter. The Catheter is marked with numbers or 
rings at each centimeter between 3 cm and 15 cm from the proximal tip (Figure 11). These markings serve 
as a scale to determine depth of insertion. The Catheter characteristics vary by catalog number (Appendix 
I ).  
 
 
Figure 11. The Codman Bactiseal EVD Catheter 
 
 
 

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 External Ventricular Drainage Catheters  
External ventricular drainage Catheters (Figure 12) are indicated for drainage and monitoring of CSF from 
the lateral ventricles of the brain. The Catheters may be used to reduce ICP, to monitor ICP, to monitor 
CSF and in the management of hydrocephalic shunt infections. 
The Ventricular Catheters are designed for diverting fluid from the ventricles through a series of drainage 
holes near the Catheter tip. The Catheters can be inserted into the ventricular cavity with the stainless-
steel stylet. A trocar is supplied with the Catheters to facilitate subcutaneous tunneling away from the 
burr hole. The external portion of the Catheter may be secured to the scalp by the suture collar.  
All external ventricular Catheters have markings from 3 to 15 cm ± 1.5 mm with numbers located at odd 
markings and dots located at even markings. All Catheters have a radiopaque tip: The Product Code INS-
8220 Catheter is barium impregnated and the Product Code INS-4000, INS-4500 and INS-8420 are barium 
striped. An overview of all EVD Catheters and Accessories is provided in APPENDIX I. 
 
 
Figure 12. External Ventricular Drainage Catheters 
 
 
 Codman® EDS 3TM Clear Ventricular CSF Catheter 
The Codman® EDS 3TM Clear Ventricular CSF Catheter is indicated for gaining access to the ventricles of 
the brain. It is a 35cm clear silicone Catheter with a radiopaque strip. 
 

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2.2.4 EVD Accessories 
 Pole Mount Assemblies and Accessories 
The MoniTorr ICP™ Pole Mount Assembly provides support and alignment for External Ventricular 
Drainage Systems. The Pole Mount Sliding Bracket can be used with the Integra External Ventricular 
Drainage Systems and may also be used as a replacement assembly or accessory component (Figure 13). 
The Pole Mount Sliding Bracket is used to secure the External Ventricular Drainage System to the rail of 
the Pole Mount Assembly. The Pole Mount Assembly incorporates a removable rail graduated in cm H20 
and/or mmHg, a sliding bracket which facilitates secure attachment of the External Ventricular Drainage 
System through 2 keyholes located at the top of the system panel, and a pointer that is extendible to 
approximately 75 cm is attached to the bracket for easy alignment to patient’s Foramen of Monro. 
 
Figure 13. Pole Mount Assembly 
 
2.2.5 Contraindications  
Refer to the Instructions for Use for the contraindications specific for each device.  
2.3 Intended Purpose in the post-market clinical follow-up registry 
The External Ventricular Drainage Systems and Accessories will be used within label in this registry and 
the registry is of observational nature. There will be no specific medical or surgical procedures involved in 
the use of the study device, other than the standard of care. A full description of the medical and surgical 
procedures related to the External Ventricular Drainage Systems are available in the Instructions for Use. 
2.4 Required training and experience 
The External Ventricular Drainage Systems and Accessories will be used within label in this registry study. 
The investigators working with these systems have been previously trained on the use of the devices and 
should be familiar with their use prior to taking part in this registry study. Integra LifeSciences Corporation 
does not train, nor dictate, the shunt implantation technique. All investigators must meet certain 
expectations per Sponsor Standard Operating Procedures (SOPs).  

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2.5 Device Accountability 
Given the post-market design of this registry, no device accountability will be performed for the purposes 
of this registry study.  
2.6 Device Traceability 
Devices will be tracked by Model, SKU, and LOT numbers, as applicable, which will be part of the data 
entered into the database of this registry. 
 
3 OBJECTIVES AND ENDPOINTS 
3.1 Primary Objective 
The primary objective of this registry is to capture clinical performance data to confirm the continued 
performance of the External Ventricular Drainage Systems and Accessories. 
 
3.2 Safety Objective 
The safety objective of this registry is to capture clinical safety data to confirm the continued safety of 
the External Ventricular Drainage Systems and Accessories. 
 
3.3 Primary Endpoint 
The primary endpoint is anticipated drainage (i.e., observed drainage consistent with the patient’s 
clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer 
required.  
 
Note: Excessive drainage (e.g., more than 25 cc every hour) not attributable to the patient’s condition, 
widely variable drainage over time inconsistent with the patient’s clinical presentation, drainage levels 
inconsistent with concurrent neurological exams (e.g., GCS, NIHSS, etc.), and/or documented device 
deficiencies impacting drainage (e.g., breakage disconnection, etc.) are examples of unanticipated 
drainage of CSF that will be recorded as Adverse Events.  
 
3.4 Secondary Endpoint 
The secondary endpoint is the proportion of patients in whom the CODMAN Cranial Access Kit, when 
used with appropriate accessories, provided successful access to the intracranial space. 
 
3.5 Tertiary Endpoints 
• 
Number of initial Catheter Insertion Attempts [Time Frame: Implantation of subject] Number of 
insertions needed to place Catheter. 

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• 
Number of days initial Catheter is in place.  
• 
Number of Catheter and/or EVD System replacements during treatment, if applicable. 
• 
Number of Catheter flushing interventions per each Catheter if a replacement Catheter is implanted. 
• 
Length of Catheter Tunneling into the Brain [Time Frame: Implant of subject] Length of tunneling of 
EVD Catheter in the brain for each analysis population.  
• 
Number of Days with initial Indwelling Catheter [Time Frame: Implant of subjects to the day of 
explant] Days Catheter was implanted in subjects 
• 
Non-infectious Catheter Failure in the ITT Population [Time Frame: Implant of subject to explant] 
Reasons for non-infectious Catheter malfunctions in the intent to treat population. 
• 
CSF daily drainage. 
 
3.6 Safety Endpoints 
1. Device- or procedure-related adverse events (AEs) during the use of the device in the patient. 
2. Noted Device Deficiencies during use of the device such as malfunction, use errors, or other 
issues related to the performance or safety of the External Ventricular Drainage Systems and 
Accessories. 
 
 

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4 RISKS AND BENEFITS OF THE REGISTRY STUDY 
 
4.1 Anticipated Clinical and Device Benefits 
There are no anticipated clinical benefits for the patient as a result of participation in this registry. An 
increased review of a patient’s procedural and follow-up data in addition to standard of care may be 
beneficial to the patient but is not guaranteed. 
4.2 Anticipated Adverse Device Effects/Residual Risks 
The External Ventricular Drainage Systems and Accessories will be used according to standard of care. 
Expected side-effects for patients participating in this registry are therefore not different than expected 
side-effects without participation. 
4.3 Risks Associated with Participation in the Registry study 
The External Ventricular Drainage Systems and Accessories will be used within label in this registry study 
and the study is of observational nature. Patients will not be asked to change their medical or medication 
treatments other than standard of care. There are no device-related risks for this study. There are, 
however, privacy (loss of confidentiality) risks associated with participation in the registry.  
4.4 Risk Control/Mitigation 
This registry does not add any additional risk compared to the risks associated with the use of the External 
Ventricular Drainage Systems and Accessories outside of this study. 
Participation in the study does not submit the patient to any additional procedures or exams outside the 
customary standard of care. Patient confidentiality and privacy is strictly held in trust by the participating 
investigators, their staff, and the Sponsor. The patient’s data will be given a code in order to assure that 
the data can only be traced with the use of an identifier. The identifier will be stored securely in the local 
research institute. Data that is shared with the Sponsor will only contain the code and the name and any 
other identifiable information will be omitted. Please refer to Section 12.1.3 for additional information. 
Therefore, there is no additional risk for taking part in this study.  
4.5 Risk/Benefit Analysis 
The participation in the registry does not add risks to the patients, thus the benefit is judged to outweigh 
the overall residual risks. 
 
 

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5 STUDY DESIGN 
5.1 Overall Design 
The External Ventricular Drainage Post-Market Clinical Follow-Up (PMCF) registry is an observational, 
multi-center, post-market study.  
5.2 Description of Sites 
Up to 15 sites in EU countries, UK and Switzerland will participate in this study. Sites will be chosen based 
upon their experience with the EVD System and accessories and their ability to fulfill general requirements 
in the Sponsor’s SOPs.  
5.3 Rationale for Study Design 
The purpose of this study is to investigate whether the Integra External Ventricular Drainage Systems 
listed as part of this registry do perform to clinical expectations. 
Additionally, this study will focus on the safety of these devices by collecting any device-specific AEs or 
DDs seen when used during standard of care procedures. 
 
A registry is the most appropriate design for a study such as this because registries proactively collect 
study data, but do not needlessly expose patients to non-standard of care interventions or procedures. 
Additionally, registries include data from patients with complex medical histories which will generally 
provide more real-world evidence. 
 
Including multiple centers and nations will ensure that data collected is from a broad set of surgeons 
and countries, thereby increasing the generalizability of the outcomes and conclusions. 
 
Study outcomes will be summarized using descriptive statistics. Categorical variables will be summarized 
using frequencies and percentages. Continuous variables will be summarized using means, standard 
deviations, medians, ranges, and numbers of observations. 
 
A sample size of 120 patients will be enrolled for this registry. Inclusion will be halted at sites that reach 
the 34% (40 subjects) inclusion cap. There will be no minimum number of subjects for a single study site. 
 
Integra LifeSciences Corporation believes this study design and sample size is appropriate to confirm the 
continued safety and performance of these devices given their well-established nature and the existing 
clinical evidence base. 
5.4 End of Study Definition Overview 
The end of the study is defined as completion of case report forms for the last subject in the registry study. 
5.5 Primary Study Hypothesis 
The primary hypothesis is to evaluate the success rate of CSF drainage against a pre-defined performance 
goal of 80% (with an expected success rate of 90% or higher). The hypothesis will be tested based on 
patients of all ages using the exact method along with two-sided 95% confidence interval.  

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6 STUDY POPULATION 
6.1 Inclusion Criteria 
In order to be eligible to participate in this study, Patients must meet all of the following criteria: 
1. Patient and/or legally authorized representative has agreed to participate in the study by signing 
the EC-approved consent form, where applicable. 
2. Patients (of any age) who underwent or who plan to have a procedure with one of the Integra or 
Codman External Ventricular Drainage as distributed by Integra System. 
3. For patients who have had the EVD System removed prior to study enrollment, have available 
follow-up data from implant until the EVD System is no longer required for drainage and 
monitoring of CSF. 
 
6.2 Exclusion Criteria 
Patients who meet any of the following criteria will be excluded from participation in this study: 
1. The Patients in whom more than one EVD System were or are intended to be placed. 
2. The Patient has sepsis. 
3. The Patient has a history of poor wound healing. 
4. The patient exhibits signs of scalp infection prior to implantation that would be contraindicated 
per the IFU. 
5. The Patient is otherwise determined by the Investigator to be medically unsuitable for 
participation in this Registry. 
6. The Patient is currently enrolled in another device trial or has been previously entered in this 
trial. 
7. The Patient is a prisoner or member of a different vulnerable population that should not be 
included in the study per the investigator. 
8. The Patients known to have uncorrected coagulopathy. 
9. The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to 
implantation of Bactiseal catheters) 
 
6.3 Point of Enrollment & Enrollment Period 
This is an observational study, and the patients will only provide informed consent to allow use of their 
data. All consented patients are assigned a study identification (ID) number and screened for eligibility in 
the study. The study will collect data on each patient from (1) the start of the procedure involving External 
Ventricular Drainage Systems or Accessories until the EVD System is no longer required for drainage and 
monitoring of CSF, and (2) in patients who have met all eligibility criteria. Patients eligible for the study 
are identified and informed consent is obtained prior or after the start of treatment with the devices. In 
case informed consent is obtained: 

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• 
Prior to the start of the treatment with the EVD System and Accessories, the data will be 
prospectively collected from the implantation procedure until the EVD System is no longer 
required for drainage and monitoring of CSF. 
• 
After the implantation of the EVD System and Accessories and before the EVD System is no longer 
required for drainage and monitoring of CSF, the data will be retrospectively collected from the 
implantation procedure until the point of informed consent and prospectively collected until the 
EVD System is no longer required for drainage and monitoring of CSF. 
• 
After the EVD System is no longer required for drainage and monitoring of CSF, the data will be 
retrospectively collected from the implantation procedure until the EVD System is no longer 
required for drainage and monitoring of CSF. 
This registry study is anticipated to have an enrollment period of 25 months. 
6.4 Comparison of Study Population to Target Population 
The registry aims to collect information from patients that represent all ages, demographics, and regions 
to ensure that the data and conclusions generated from this study are as generalizable as possible while 
still matching the intended patient population as defined in the Instructions for Use. The patient 
population of this study will reflect patients who have had a TBI, undergone a major neurosurgical 
procedure, or some other traumatic, ischemic or hemorrhagic incident requiring EVD. 
6.5 Screen Failures and Failures  
Participants who are consented to participate in the registry, who do not meet one or more criteria 
required for participation in the study during the screening procedures, are considered screen failures. 
Participants who underwent or undergo a replacement of the Integra or Codman EVD System with an EVD 
System other than an Integra or Codman EVD System are considered failures and will be discontinued 
from the date of the Integra or Codman EVD System replacement. The data collected up to the date of 
the Integra or Codman EVD System replacement will be included as part of the registry study results, as 
permitted by national laws and regulations. 
7 STUDY INTERVENTION/INVESTIGATIONAL PRODUCT 
Not applicable – This is a registry; no interventions or investigational products will be used. 
 
8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 Informed Consent 
Informed consent will occur prior to data collection. Section 12.1.1. should be consulted for this process. 

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8.2 Performance Data to be Collected 
Completion of Worksheets/Case Report Forms (CRFs). Sites will transcribe/transmit the information 
outlined below in study worksheets and CRFs. This information will originate from existing medical and 
other patient records. 
Patient Data: 
• 
Demographics: 
o Gender 
o Year of Birth (YOB) 
• 
Prescribed clinical diagnosis for CSF drainage (e.g., reason the physician prescribed CSF drainage) 
Procedural Data: 
• 
Procedural Information CSF drainage: 
o Dates of EVD System and Accessories placement and removal. 
o Details of Catheter and/or EVD System replacement(s), if applicable. 
o Number of initial Catheter Insertion Attempts i.e., number of insertions needed to place 
Catheter 
o Length of Catheter Tunneling into the Brain i.e., length of tunneling of EVD Catheter in 
the brain 
o External Ventricular Drainage System and/or accessories used: 
 
Brand name 
 
Model, SKU, and LOT number(s), if documented 
Clinical Performance Data: 
• 
Daily CSF drainage until the EVD System is no longer required for drainage and monitoring of CSF. 
• 
Intracranial access location  
• 
EVD System and Accessories maintenance procedures 
• 
Number, type, and volume of flush(s) used to address occlusions, if applicable.  
• 
Concomitant neuro-interventional and neurosurgical procedures 
• 
Relevant concomitant medications 
• 
Whether the patient required a permanent shunt after the EVD System is no longer required for 
drainage and monitoring of CSF, if so (name, model) 
• 
In the case of a malfunctioning EVD system and/or Accessories, the component(s) responsible for 
malfunction or reason for malfunction (where possible) 
 
8.3 Safety and Other Assessments 
• 
Assessment of events related to EVD system and accessories or procedure 
o Medical records will be reviewed for all events that occurred between index procedure 
and until the EVD System is no longer required for drainage and monitoring of CSF. See 

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Section 9.1 for complete definitions and information on assessing and documenting 
events. 
• 
Assessment of noted Device Deficiencies during use of the EVD system and accessories 
o Medical records will be reviewed for device deficiencies (DD) that were documented that 
occurred between index procedure and until the EVD System is no longer required for 
drainage and monitoring of CSF. See Sections 9.1.3 and 9.7.3 for complete definitions and 
information on assessing and documenting device deficiencies. 
8.4 Concomitant Medication Review 
The patient’s relevant concomitant medications (i.e. current medication) will be recorded. Medication is 
considered relevant when associated with an adverse event related to the device or procedure as 
determined by the investigator. 
The relevant medications will be documented from device implant until the EVD System is no longer 
required for drainage and monitoring of CSF. All medications as part of AE treatment must be noted 
as such on the AE CRF and on the ConMed CRF. If there was a change in dose, frequency, or route of 
medication, this change must be entered into the ConMed CRF as a new medication. The previous 
medication will be noted as being stopped. 
 
9 SAFETY  
9.1 Definitions 
9.1.1 Adverse Device Effect (ADE) 
Adverse event related to the use of an investigation medical device. 
NOTE 1: This includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational device. 
NOTE 2: This includes any event resulting from use error or from intentional misuse of the investigational 
device. 
9.1.2 Adverse Events (AE) 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users, or other persons, whether related to the 
investigational medical device or not and whether anticipated or unanticipated. 
NOTE 1: This includes events related to the investigational medical device. 
NOTE 2: This includes events related to the procedure involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to the use of the 
investigational medical device. 

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9.1.3 Device deficiency 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety 
and performance. 
NOTE 1: Device deficiencies include malfunction, use error, and inadequacy in the information supplied 
by the manufacturer including labelling. 
9.1.4 Incident 
Any malfunction or deterioration in the characteristics or performance of a device made available on the 
market, including use-error due to ergonomic features, as well as any inadequacy in the information 
supplied by the manufacturer and any undesirable side-effect. 
9.1.5 Malfunction 
Failure of an investigational medical device to perform in accordance with its intended purpose when 
used in accordance with the instruction for use. 
9.1.6 Serious Adverse Device effect (SADE) 
Adverse device effect that has resulted in any of consequences characteristic of a serious adverse event 
9.1.7 Serious Adverse Events (SAE) 
AE that led to any of the following: 
a) death,  
b) serious deterioration in the health of the subject, users, or other persons as defined by one or 
more of the following:  
1) a life-threatening illness or injury, or  
2) a permanent impairment of a body structure or a body function including chronic 
diseases, or  
3) in-patient or prolonged hospitalization, or  
4) medical or surgical intervention to prevent life-threatening illness or injury, or permanent 
impairment to a body structure or a body function,  
c) fetal distress, fetal death or a congenital abnormality, or birth defect including physical or mental 
impairment.  
Note 1: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigation plan, without serious deterioration in health, is not considered a SAE. 
 
9.1.8 Unanticipated Serious Adverse Device effect (USADE) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified 
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Note 1: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence 
severity or outcome has been identified in the risk assessment. 
9.1.9 Unanticipated Serious Incident 
Any incident that directly or indirectly led, might have led or might lead to any of the following:  
a. the death of a patient, user or other person,  
b. the temporary or permanent serious deterioration of a patient's, user's or other person's state of 
health,  
c. a serious public health threat 
9.2 Classification 
 Severity of Event 
All events will be described by their severity level. In this study, one of the following levels will be assigned 
by the investigator:  
• 
Mild – Symptoms barely perceptible to the subject, do not affect his/her performance or activity, 
do not normally require the administration of drugs for relief of the symptoms, but they may, 
however, be administered depending on the subject’s needs.  
• 
Moderate – Symptoms sufficiently serious to cause patient discomfort, having impact on the 
performance of daily activities; the subject may be able to continue in the study, but it may be 
necessary to treat the symptoms.  
• 
Severe – Symptoms cause serious discomfort and they may be serious to a degree that the patient 
may not be able to continue in the study; treatment may be administered for the symptoms 
and/or the patient hospitalized.  
If the severity of an event changes at any time in its duration, the site should update the related CRF 
accordingly. 
9.3 Relationship to Study Intervention 
All reported events must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the subject based on temporal relationship and his/her clinical judgement. The 
Sponsor and the investigators will use the following definitions to assess the relationship of the AE to the 
investigational medical device or procedures (Medical Device Coordination Group [MDCG] 2020-10/1, 
May 2020). 
Not related: relationship to the device or procedures can be excluded when:  
- 
the event has no temporal relationship with the use of the investigational device, or the 
procedures related to application of the investigational device;  
- 
the event does not follow a known response pattern to the medical device or procedure(s) (if the 
response pattern is previously known) and is biologically implausible;  
- 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the event;  

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- 
the event involves a body-site or an organ that cannot be affected by the device or procedure;  
- 
the event can be attributed to another cause (e.g., an underlying or concurrent illness/ clinical 
condition, an effect of another device, drug, treatment, or other risk factors);  
- 
the event does not depend on a false result given by the investigational device used for diagnosis3, 
when applicable. 
To establish the non-relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
Possible: the relationship to the use of the investigational device, or the relationship with investigational 
procedures, is weak but cannot be ruled out completely. Alternative causes are also possible (e.g. an 
underlying or concurrent illness/ clinical condition or/and an effect of another device, drug, or treatment). 
Cases where relatedness cannot be assessed, or no information has been obtained should also be 
classified as possible.  
Probable: the relationship to the use of the investigational device, or the relationship with procedures, 
seems relevant and/or the event cannot reasonably be explained by any other cause. 
Causal relationship: the event is associated with the investigational device or with procedures beyond 
reasonable doubt when:  
- 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;  
- 
the event has a temporal relationship with investigational device use/application or procedures;  
- 
the event involves a body-site or organ that 
• 
the investigational device or procedures are applied to;  
• 
the investigational device or procedures have an effect on;  
- 
the event follows a known response pattern to the medical device (if the response pattern is 
previously known);  
- 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically feasible);  
- 
other possible causes (e.g. an underlying or concurrent illness/clinical condition or/and an effect 
of another device, drug, or treatment) have been adequately ruled out;  
- 
harm to the subject is due to error in use; 
- 
the event depends on a false result given by the investigational device used for diagnosis3, when 
applicable. 
To establish the relatedness, not all the above listed criteria must be met at the same time, depending on 
the type of device/procedures and the event. 
 
3 If an investigational device gives an incorrect diagnosis, the patient might, for example, receive an unnecessary 
treatment and incur all the risks that accompany that treatment, or might be incorrectly diagnosed with a serious 
disease. In other cases, the patient might not receive an effective treatment (thereby missing out on the benefits 
that treatment would confer), or might not be diagnosed with the correct disease or condition. 

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The Sponsor and the investigators will distinguish between the events related to the investigational device 
and those related to the procedures (any procedure specific to the registry study). An event can be related 
both to procedures and the investigational device. Complications caused by concomitant treatments not 
imposed by the clinical investigation plan are considered not related. Similarly, several routine diagnostic 
or patient management procedures are applied to subjects regardless of the clinical investigation plan. If 
routine procedures are not imposed by the clinical investigation plan, complications caused by them are 
also not related. 
In some cases, the event may not be adequately assessed because information is insufficient or 
contradictory and/or the data cannot be verified or supplemented. The Sponsor and the investigators will 
make the maximum effort to define and categorize the event and avoid these situations. Where an 
investigator’s assessment is not available and/or the Sponsor remains uncertain about classifying the 
event, the Sponsor should not exclude the relatedness; the causality of the event should be classified as 
“possible” and the reporting should not be delayed. 
Special attention shall be given to the causality evaluation of unanticipated serious adverse (device) 
events. The occurrence of unanticipated events could suggest that the registry study places subjects at 
increased risk of harm than was to be expected beforehand. 
 
 
 

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9.4 Expectedness 
The investigator and the Sponsor will be provided an initial assessment as to the expectedness (i.e., 
whether an event is anticipated or unanticipated) of an event. An event will be considered unanticipated 
if the nature, severity, or frequency of the event is not consistent with the risk information described for 
the External Ventricular Drainage Systems or accessories, or the surgical procedure. A list of anticipated 
AEs can be found in the following section. 
Important: Anticipated and unanticipated designations do not revolve around whether the 
investigator/Sponsor thought an event would happen in a particular patient. Expectedness only speaks to 
whether the investigator/Sponsor has seen this type of event before with the use of the product (or class 
of products) or as a result of a procedure. Please see the decision tree below (Figure 7) to assist in 
determination.  
Figure 14. Expectedness determination of investigational device or procedure related AEs 
9.4.1 Anticipated Adverse Device Effects 
Complications which may result from the use of the EVD systems include the risks associated with the 
medications and methods utilized in the surgical procedure, as well as the patient’s degree of intolerance 
to any foreign object implanted in the body. 
The principal complications associated with cerebrospinal fluid drainage are Catheter obstruction, 
infection (including meningitis and ventriculitis), intracranial hypotension/hypertension, migration of 
ventricular Catheters, ventricular collapse, and intracerebral hemorrhage. 
Is the  
nature, severity, or 
frequency of the event 
consistent with the risk 
information previously 
described for the 
product or procedure? 
Is the event possibly, 
probably, or causally 
related to the Device?  
Yes 
Expectedness 
is Not 
Applicable 
No 
This event is 
ANTICIPATED  
Yes 
This event is UNANTICIPATED 
 
No 
Start 
Is the event possibly, 
probably, or causally 
related to the Surgery? 
Yes 
No 

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Excessive lowering of ICP in infants may result in complications which include subdural hematomas, 
markedly sunken fontanelles, overriding of cranial bones, and conversion of a communicating to a non-
communicating hydrocephalus. 
Ventricular Catheters may be obstructed by particulate matter such as blood clots, fibrin, or brain 
fragments. If not properly located in the lateral ventricle, the ventricular Catheter may become embedded 
in the ventricular wall or choroid plexus. Less commonly, the ventricular Catheter may be obstructed by 
the excessive reduction of ventricular size to slit like proportions. 
Complications that are specific for the use of the Cranial Access Kits are improper use of the hand drill 
including failure to properly secure the drill bit to the variable chuck or failure to properly secure the depth 
guard to the drill bits. Improper use of the hand drill may result in serious injury. Bleeding may occur at 
the site of the drill hole, originating from the scalp, bone, dural, or cerebral areas. Due to the possibility 
of cerebral or extra cerebral hemorrhage or any other complication of this procedure, drill hole placement 
is the sole responsibility of the attending neurosurgeon. 
9.5 Adverse Event Coding 
Adverse Events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding 
platform. 
9.6 Time Period and Frequency for Event Assessment and Follow-Up 
As previously described, investigators and/or their staff will review the patient’s medical record for events 
that occurred from device implant until the subject exits the study. 
All events will be captured on the appropriate CRF. When possible, signs and symptoms indicating a 
common underlying pathology should be noted as one comprehensive event (i.e., [possible] influenza 
instead of chills, fever, and vomiting). The investigator or designee should, to the best of their ability, 
endeavor to document an outcome/resolution for the event. If no resolution can be found in the medical 
record, the site will note it as ongoing. 
Any medical condition that is present at the time that the subject is screened will be considered as baseline 
(i.e. medical history and/or conditions) and not reported as an event. However, if the study subject’s 
condition deteriorates at any time during the study, it will be recorded as an event. Any 
procedures/surgeries should be documented on the Concomitant Neurosurgical and Neuro-
interventional Procedures Log from device implant until the until the subject exits the study. 
Changes in the severity of an event will be documented to allow an assessment of the duration of the 
event at each level of severity to be performed. Events characterized as intermittent require 
documentation of onset and duration of each episode. 
 
 

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9.7 Event Reporting 
All AEs and SAEs information will be collected on all subjects regardless the AE or the SAE is procedure- or 
device related. AE and SAE recording will start at the point of device implant until the subject exits the 
study. 
Each event must be described as follows in the Electronic Data Capture (EDC) system:  
• 
Event Term: A medically defined diagnosis/symptom. Use the highest level of evidence available.  
o Level 1: Diagnosis 
o Level 2: Symptoms 
o Level 3: Signs 
• 
Event Description: Explain the circumstance of becoming aware of the event, how the subject 
explained the circumstances surrounding the onset of the event, the underlying cause (the 
diagnosis), coexisting disease, or other condition or complaint involving the event. 
• 
Event Duration: Document by entering the date of onset (start date) and date of resolution (stop 
date).  
• 
Event Attribution/Causality: Document causal relationship between event and the investigational 
product (e.g., causally related, probable, possible, unrelated). 
• 
Event Seriousness: Document as serious or not serious. 
• 
Event Severity: Document as mild (transient and easily tolerated by the subject), moderate 
(discomfort and interrupts normal activities), or severe (incapacitating with inability to work or 
do usual activity). 
• 
Treatment: Document as none, medication, hospitalization, surgical, and/or other. Any prescribed 
medication should be noted in the subject’s medical records and transcribed onto the event and 
Concomitant Medications CRFs. If a surgical or invasive procedure is required for an event, 
document the procedure on the Procedure Log.  
• 
Outcome: Document as recovered without sequelae, recovered with sequelae, ongoing, death, 
or other. Events will be followed until a resolution has occurred, until a resolution is no longer 
expected, the pre-existing condition returns to baseline conditions, or the subject exits the study. 
9.7.1 Event Reporting to Regulatory Authorities 
All events will be communicated directly to the Sponsor by the investigator or designee. Event reporting 
will be collected since the time of implant and reported in the EDC. event information will be collected for 
all events. Event information will be collected on all patients.  
Integra LifeSciences Corporation is responsible for the management of the device vigilance database and 
shall notify the relevant competent authority of incidents that occurred during the registry study, in 
accordance with Integra LifeSciences Policies and SOPs, the requirements and all applicable regulations. 
9.7.2 Reporting to Ethics Committees  
Prior to initiation of the registry study, reporting requirements for each Ethics Committee (EC), where 
applicable, will be verified and documented. Reporting will occur according to the requirements set forth 
by each involved EC and/or national requirements, where applicable, whichever is the most stringent.   

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9.7.3 Reporting of Device Deficiencies (DDs) 
The principal investigator shall record every observed DD together with an assessment. All DDs including 
the analysis of used or explanted investigational devices, where applicable, shall be documented 
throughout the registry study and managed by the Sponsor. 
In this study, review of potential DDs in a patient’s medical records will occur from the date of implant to 
the date of explant. 
The Sponsor is responsible for the classification of events and ongoing safety evaluation of the registry 
study and shall review all DDs. The investigator and Sponsor will determine and document whether the 
DD could have led to a serious adverse device effect (SADE). In case of disagreement between the Sponsor 
and the principal investigator(s), the Sponsor shall communicate both opinions to concerned parties 
described further below in this section. 
Every attempt should be made by the Site to save or collect the defective device and packaging, if 
appropriate, for return to the Sponsor. A qualified company representative will investigate and determine 
root cause and corrective actions as applicable, and directives will be provided to the site if warranted. 
The investigator shall:  
• 
report to the Sponsor, without unjustified delay, all DDs that could have led to a SADE via the 
supplied CRF (definition in section 9.1).  
• 
report to the EC any DDs that could have led to a SADE, if required by the national regulations or 
by the EC,  
• 
report to regulatory authorities any DDs that could have led to a SADE, as required by the national 
regulations, and  
• 
supply the Sponsor, upon Sponsor’s request, with any additional information related to the safety 
reporting of a particular event.  
It should be noted that no documents should be submitted to any regulatory agency/ EC without approval 
by the Sponsor beforehand to assure accuracy and completeness of the information.  
All DDs related to the identity, quality, durability, reliability, usability, safety or performance of an 
investigational device including the analysis of used or explanted investigational devices, where 
applicable, shall be documented throughout the registry study and managed by the Sponsor through 
internal SOPs. 
 
 

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10 PATIENT DISCONTINUATION OF CONSENT FOR THE STUDY 
IMPORTANT: This section is only applicable to sites and/or patients who have consented to have their 
data collected as part of this registry.  
Patient participation in the registry study is considered complete when the EVD System is no longer 
required for drainage and monitoring of CSF. The registry study is considered complete upon the EVD 
System is no longer required for drainage and monitoring of CSF of the last patient.  
A patient may withdraw consent for data to be collected in the registry study at any time during the 
registry study. The patient does not have to give a reason for withdrawal of consent. The investigator may 
exclude a patient if the patient or the patient’s data does not fulfil the eligibility criteria (Section 6.1-6.2). 
The investigator may also decide to stop collecting a patient’s data for the registry study if the investigator 
feels it is in the patient’s best interest. 
The Sponsor or its representative shall be notified immediately when a patient’s consent is withdrawn or 
discontinued for any reason. Premature registry study end date and reason (if known) shall be 
documented on the CRF. 
The data collected up to the date the patient has withdrawn consent will be included as part of the registry 
study results, as permitted by national laws and regulations. Additional safety information may be 
requested from a withdrawn or discontinued patient if it is considered clinically relevant. 
 
 
 
 
 
 

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11 STATISTICAL CONSIDERATIONS 
11.1 
Statistical Hypotheses 
The primary hypothesis is to evaluate the anticipated drainage (i.e., observed drainage consistent with 
the patient’s clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System 
is no longer required.  
 
Note: Excessive drainage (e.g., more than 25 cc every hour) not attributable to the patient’s condition, 
widely variable drainage over time inconsistent with the patient’s clinical presentation, drainage levels 
inconsistent with concurrent neurological exams (e.g., GCS, NIHSS, etc.), and/or documented device 
deficiencies impacting drainage (e.g., breakage disconnection, etc.) are examples of unanticipated 
drainage of CSF that will be recorded as Adverse Events.  
 
The hypothesis is formulated as  
H0: P ≤ 80%     vs.   Ha: P > 80% 
where P is the proportion of patients with clinical success.  
The hypothesis will be evaluated using exact method along with two-sided 95% confidence interval. A P-
value of less than 0.05 is considered statistically significant. 
    
11.2 
Sample Size Determinations 
A sample size of 110 is estimated by pre-defined performance goal of 80% along with two-sided 95% 
confidence interval with 80% power for the primary endpoint. A total of 120 subjects will be enrolled with 
8% potential drop-out assumed.  The registry will enroll patients who meet the eligibility criteria with an 
expected total sample size of 120 patients that underwent the procedure with one or more of the Integra 
devices at up to 15 study sites.  Enrollment will be halted at sites that reach the 34% (40 subjects) inclusion 
cap. There will be no minimum number of subjects for a single study site.  
The device systems have been on the market for more than 15 years and have substantial clinical evidence 
of safety and performance in the form of several peer-reviewed publications and post-market clinical 
experience data. In this study, data from multiple centers and nations will be included to ensure that the 
collected data is from a broad set of surgeons and countries, thereby increasing the generalizability of the 
outcomes and conclusions. 
Integra believes this study design and size is appropriate to confirm the continued safety and performance 
of these devices given their well-established nature and the existing clinical evidence base.  
11.3 
Populations for Analyses 
The Intent to Treat (ITT) population consists of all patients who signed the written informed consent and 
are considered to meet all inclusion/exclusion criteria (patients included in the study) following the 
Intention To Treat principle whether patients have or not a procedure with one of the Integra or Codman 
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The Full Analysis Set (FAS) population consists of all patients included in the study who have a procedure 
with one of the Integra or Codman External Ventricular Drainage System.  The primary endpoint and all 
other endpoints analyses will be based on the FAS population.   
The Per Protocol Set (PPS) population consists of all patients who have a procedure with one of the Integra 
or Codman External Ventricular Drainage System and meet all inclusion/exclusion criteria.  Endpoints 
analyses based on the PPS population will be supportive.   
11.4 
Statistical Analyses 
11.4.1 General Approach 
Descriptive statistics will be presented (e.g., number of observations, percentage, mean with standard 
deviation, median, range). Individual patient summaries will be tabulated in data listings. All observed 
data will be included.  
Descriptive summaries will be the basis of study reports to generate an overall summary of the population 
characteristics and outcomes. Continuous outcome variables will be presented as means and standard 
deviations, as well as medians and ranges as appropriate. For categorical outcome variables, counts and 
percentages of subjects by category will be provided. Descriptive tables will be produced where 
applicable. 
Statistical analyses will be performed using SAS/STAT software, Version 9.4 or higher of the SAS System 
for Windows. 
Additional details on the analysis as well as any changes from the analysis plans presented in the protocol 
are provided in the Statistical Analysis Plan (SAP). 
11.4.2 Measures to Minimize Bias 
Potential for bias during this registry has been minimized by a well-controlled design, expected conduct 
under the terms of an approved clinical investigation plan and prospectively defined methods of data 
analysis. All patients meeting the criteria will have all available data relevant to the registry objectives 
collected. No blinding/masking will be conducted. Any known or foreseeable factors that may 
compromise the outcome of the registry study or the interpretation of results have been accounted for 
by the design of the registry study.  
11.4.3 Analysis of the Primary Endpoint 
The primary endpoint of this registry is the anticipated drainage (i.e., observed drainage consistent with 
the patient’s clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System 
is no longer required.   
   
The number and percentage of patients with anticipated drainage (i.e., observed drainage consistent with 
the patient’s clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System 
is no longer required will be presented. The primary hypothesis will be tested using the exact (Clopper-

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Pearson) method along with two-sided 95% confidence interval. The primary objective will be met if the 
lower bound of the 95% confidence interval is greater than the performance goal of 80%.  
11.4.4 Analysis of the Secondary Endpoint 
The secondary endpoint is the proportion of patients in whom the CODMAN Cranial Access Kit, when 
used with appropriate accessories, provided successful access to the intracranial space.  The number 
and percentage of patients with intracranial space success, along with two-sided 95% confidence 
interval of the percentage will be provided.   
 
11.4.5 Analysis of the Tertiary Endpoints 
The tertiary endpoints include: 
• 
Number of initial Catheter Insertion Attempts [Time Frame: Implantation of subject] Number of 
insertions needed to place initial Catheter 
• 
Number of days initial Catheter is in place.  
• 
Number of Catheter and/or EVD System replacements during treatment, if applicable. 
• 
Number of Catheter flushing interventions per each Catheter if a replacement Catheter is 
implanted. 
• 
Length of Catheter Tunneling into the Brain [Time Frame: Implant of subject] Length of tunneling 
of EVD Catheter in the brain for each analysis population.  
• 
Number of Days with initial Indwelling Catheter [Time Frame: Implant of subjects to the day of 
explant] Days Catheter was implanted in subjects 
• 
Non-infectious Catheter Failure in the intent-to-treat (ITT) Population [Time Frame: Implant of 
subject to explant] Reasons for non-infectious Catheter malfunctions in the ITT population. 
• 
CSF daily drainage 
Descriptive statistics will be provided to summarize the secondary endpoints.  Continuous outcome 
variables will be presented as means, standard deviations, medians, and ranges as appropriate. For 
categorical outcome variables, counts and percentages of subjects by category will be provided along with 
95% confidence interval of the percentage. 
 
11.4.6 Safety Analyses 
The safety endpoints of this study are: 
• 
Device- or procedure-related adverse events (AEs) during the use of the device in the patient 
• 
Noted Device Deficiencies during use of the device such as malfunction, use errors, or other issues 
related to the performance or safety of the External Ventricular Drainage Systems and Accessories 
 
AEs will be coded using the MedDRA terminology for data summaries. Each AE will be coded with 2 levels 
including Preferred Term (PT) and System Organ Class (SOC). 

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The total number of EVD system and accessories-related AEs as well as the percentage of patients with at 
least one device-related AE will be presented overall and by SOC and PT. AEs will also be tabulated by 
severity and by relationship to EVD system or accessories within each SOC and PT. A listing of EVD system 
and accessories-related AEs and SAEs will be presented respectively.  
The total number of DDs as well as the percentage of patients with at least one DD will be presented 
overall and by drainage system. A listing of DDs will be presented. 
11.4.7 Baseline Descriptive Statistics 
The baseline patient characteristics will be summarized using descriptive statistics (continuous outcome 
variables will be summarized using means and standard deviations, as well as medians and ranges; 
categorical outcome variables will be summarized by presenting the number and percentage of subjects 
in each category). 
A patient listing of this data will also be provided.  
Other data pertinent to the EVD System and Accessories or relevant patient care may be summarized.   
11.4.8 Planned Interim Analysis 
There are no planned interim analyses. 
11.4.9 Sub-Group Analyses 
Subgroup analyses will be performed for drainage systems for primary endpoint and secondary endpoint. 
The purpose of the subgroup analysis is not to reach statistically significant results within each subgroup, 
but rather to assess the consistency and robustness of the treatment effects across the subgroups. 
Descriptive statistics will be used for the subgroup analysis. Two-sided 95% confidence intervals will be 
reported as appropriate for reference purpose only. No multiplicity adjustment will be considered for the 
subgroup analysis.  
EVD Systems: 
• 
AccuDrain 
• 
Hermetic Plus 
• 
LimiTorr  
• 
MoniTorr 
• 
Codman EDS 3 / EDS 3C 
• 
Basic CSF Drainage System 
• 
External Ventricular Drainage System 
 
11.4.10 
Tabulation of Individual Participant Data 
Individual patient data will be listed by measure and time point where appropriate. 
11.4.11 
Exploratory Analyses 
Any exploratory analyses will be pre-specified in the SAP. 

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11.4.12 
Missing Data 
Analysis of performance and safety data will be primarily performed on all observed (available) data. No 
imputation methods on missing data will be performed. Based on the primary point, missing data is 
expected to be minimal. Reasonable efforts will be made to obtain complete data for all subjects. If 
despite these efforts, missing data occurs, reasons for missing data will be summarized, including 
withdrawal of consent.  
 
12 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
12.1 
Regulatory, Ethical, and Study Oversight Considerations 
12.1.1 Informed Consent Process 
 
 Consent/Assent and Other Informational Documents Provided to Participants 
Consent forms will be EC-approved, where applicable, and the participant or their legally authorized 
representative will be asked to read and review the document and provide written authorization via 
signature to participate in the registry study. 
 
 Vulnerable population 
Patients will be receiving CSF Drainage as part of standard of care and no additional risks or procedures 
will be conducted outside of standard of care.  
There may be situations where patients are treated with the External Ventricular Drainage Systems, but 
where the patients are not able to provide informed consent for data collection prior to treatment. This 
may be the case in situations such as, but not limited to, post-traumatic hydrocephalus, post-hemorrhagic 
stroke, or intercranial tumor. These situations are expected to happen relatively frequently, and data 
referring to the use of the device in these situations are considered of value for the evaluation of clinical 
safety and performance of the device.  
However, for these patients, their willingness to volunteer in data collection for the purposes of the 
registry study cannot be confirmed, and these patients thus meet the criteria of vulnerable population as 
defined in ISO 14155, Section 3.55. Therefore, in these cases, informed consent may be obtained by the 
patient’s legal authorized representative.  
 
 Consent Procedures and Documentation 
Non-vulnerable population 
Patients must be fully counseled and informed of their options, risks and benefits, and should have every 
opportunity to ask questions about participation in the registry study. This process includes a thorough 
explanation of the patient information letter and informed consent form that the patient will be asked to 
sign acknowledging that they understand and desire to participate in the registry study.  
The investigator is responsible for assuring that written informed consent is obtained from each patient 
prior to participation in the registry study. Should the investigator delegate the responsibility of 

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conducting the informed consent process to a designee, the investigator must ensure and document 
appropriate training of the authorized designee.  
The investigator will use an EC approved informed consent form, where applicable, that was prepared in 
accordance with this clinical investigation plan, ISO 14155 and regulatory requirements. 
Informed consent must always be obtained from a patient prior to initiation of any data collection dictated 
by the clinical investigation plan. A copy of the signed and dated statement of informed consent, as well 
as any other written information, will be provided to the patient.  
If new information regarding the investigational device becomes available and/or the clinical investigation 
plan changes and this information can significantly affect a patient’s future health and medical care, 
patients will be informed of the information and may be asked to sign a revised informed consent form.  
Vulnerable population 
Patients’ legally authorized representative must be fully counseled and informed of the options, risks and 
benefits, and should have every opportunity to ask questions about participation in the clinical 
investigation. This process includes a thorough explanation of the patient information letter and informed 
consent form that the legally authorized representative will be asked to sign acknowledging that they 
understand the requirements of participation in the clinical investigation.  
The investigator is responsible for assuring that written informed consent is obtained from each legally 
authorized representative prior to participation in the clinical investigation. Should the investigator 
delegate the responsibility of conducting the informed consent process to a designee, the investigator 
must ensure and document appropriate training of the authorized designee.  
The investigator will use an EC approved informed consent form that was prepared in accordance with 
this clinical investigation plan, ISO 14155 and regulatory requirements. 
Informed consent must always be obtained from the legally authorized representative prior to initiation 
of any data collection dictated by the clinical investigation plan. A copy of the signed and dated statement 
of informed consent, as well as any other written information, will be provided to the patient and the 
legally authorized representative.  
If new information regarding the investigational device becomes available and/or the clinical investigation 
plan changes and this information can significantly affect a patient’s future health and medical care, 
patients and their legally authorized representative will be informed of the information and may be asked 
to sign a revised informed consent form. 
12.1.2 Study Discontinuations and Closure 
This study may be suspended temporarily or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be provided 
by the Sponsor to investigators. Those study patients who consented to participate will be notified by 
their respective investigators, if required. If the study is prematurely terminated or suspended, the 
Principal Investigator will promptly inform their EC and provide the reason(s) for the termination or 
suspension.    

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Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to patients 
• 
Unanticipated operational difficulties or other unforeseen occurrences 
The study may resume if resolution of identified problems can be resolved. 
Upon study closure or termination, the patients will not be able to have access to the devices studied in 
this registry unless warranted by medical necessity outside of the scope of this registry. The rationale for 
this is that this is a non-interventional study. All treatments with the devices occurred outside of the 
registry and for standard of care use.   
12.1.3 Confidentiality and Privacy 
Subject confidentiality and privacy are strictly held in trust by the participating investigators, their staff, 
and the Sponsor and their collaborators (e.g., contract research organizations [CROs]). Therefore, the 
study protocol, documentation, data, and all other information generated will be held in strict confidence. 
No information concerning the study, or the data resulting from the procedures, will be released to any 
unauthorized third party without prior written approval of the Sponsor. 
All research activities will be conducted in as private a setting as possible.  
The study monitors (i.e., Clinical Research Associates), other authorized representatives of the Sponsor, 
representatives of the EC, regulatory agencies or CROs may inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and imaging records for the subjects in this study. The clinical study site will permit access to 
such records.  
The study subject’s contact information will be securely stored at each clinical site for internal use during 
the study. At the end of the study, all records will continue to be kept in a secure location for as long a 
period as dictated by the reviewing EC, Institutional policies, or Sponsor requirements, but no less than 
two (2) years after the end of the study.  
Study subject research data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at the Sponsor via an EDC system. This will not include the subject’s contact or 
identifying information. Rather, individual subjects and their research data will be identified by a unique 
study identification number. The study data entry and study management systems used by clinical sites 
and by Sponsor research staff will be secured and password protected. At the end of the study, all study 
databases will be de-identified and archived at the Sponsor. 
12.1.4 Future Use of Stored Data 
Data collected during the study may be stored for as long as needed and can be used as basis for future 
studies or regulatory filings. All data used in this manner will remain deidentified in accordance with 
Sponsor SOPs and national and local regulations. 

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12.1.5 Site Selection, Corrective and Preventative Actions, Investigator Disqualification 
Procedures governing site selection, corrective and preventive actions, and criteria for investigator 
disqualification can be located in current SOPs at Integra LifeSciences. Details about these procedures can 
be provided upon request. 
 
12.1.6 Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of participating subjects are 
protected, that the reported registry data are accurate, complete, and verifiable, and that the conduct of 
the registry is in compliance with the currently approved protocol/amendment(s), with GCP, and with 
applicable regulatory requirement(s).  
• 
Monitoring for this study will be performed by internal Sponsor representatives or by qualified 
external personnel contracted from a CRO.  
• 
Details of clinical site monitoring are documented in a Clinical Monitoring Plan (CMP). The CMP 
describes in detail who will conduct the monitoring, at what frequency monitoring will be done, 
at what level of detail monitoring will be performed, and the distribution of monitoring reports.  
• 
In brief, on-site and/or centralized review of source documents will occur after completion of 
the data collection of the final patient enrolled in this registry.  All monitoring criteria can be 
found in the most current CMP for the study.  
• 
All personnel conducting monitoring visits will be trained on the study, Sponsor SOPs, and the 
study-specific CMP ahead of the visit.  
• 
It is not anticipated that Sponsor-lead audits will be conducted as part of this study; however, 
the Sponsor reserves the right to conduct audits or to hire an external firm to perform audits if 
cause is demonstrated. 
12.1.7 Quality Assurance and Quality Control 
Each investigational site will be responsible for quality management of study conduct, data and if 
applicable biological specimen collection, analysis, documentation and completion in keeping with GCP, 
national, and local regulations. If applicable, sites will follow their internal SOPs in regard to biological 
specimen collection and analysis.  
Quality control (QC) procedures have been implemented with regard to the EDC (i.e., the database) 
system in keeping with the Sponsor’s SOPs. Data QC checks that will be run on the database will be 
generated and documented in accordance with the Sponsor’s SOPs. Any missing data or data anomalies 
will be communicated to the site(s) for clarification/resolution. Sites should aim to resolve these queries 
as soon as possible in the EDC system.  
The investigational site will provide direct access to all clinical investigation related sites, source 
data/documents, and reports for the purpose of monitoring and/or auditing by the Sponsor, and 
inspection by local and regulatory authorities. All sites will follow their institutional procedures for 
collection and storage of medical records that will become part of this dataset. 

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Data processing will be performed in compliance with the EU General Data Protection Regulation (GDPR) 
2016/679 and all applicable national laws.  
 
12.1.8 Data Handling and Record Keeping 
 
 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical investigation staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring that all data recorded meets ALCOA 
documentation standards; that is, data should (to the best of the site’s ability) be:  
• 
Attributable – It should be clear who has documented the data.  
• 
Legible – Readable and signatures identifiable.  
• 
Original – Original, if not original should be exact copy; the first record made by the appropriate 
person. The investigator should have the original source document.  
• 
Accurate – Accurate, consistent and real representation of facts.  
• 
Enduring – Long-lasting and durable.  
• 
Available and accessible – Easily available for review of treating physicians and during 
audits/inspections. The documents should be retrievable in reasonable time.  
• 
Complete – Complete till that point in time.  
• 
Consistent – Demonstrate the required attributes consistently.  
• 
Credible – Based on real and reliable facts.  
• 
Corroborated – The data should be backed up by evidence.  
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each subject enrolled in the study. Clinical data will be entered directly from the source 
documents. Data recorded in the electronic case report form (eCRF) derived from source documents 
should be consistent with the data recorded on the source documents.  
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) will be 
entered into an EDC system provided by the Sponsor. The EDC system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate. Clinical data will be entered directly from the sites’ source. 
 
 Study Records Retention 
Study documents should be retained for a minimum of 2 years after the formal discontinuation of clinical 
registry. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the Sponsor, if applicable. It is 
the responsibility of the Sponsor to inform the investigator when these documents no longer need to be 
retained.  
If deemed necessary by the investigational site, records may be placed in off-site storage; however, the 
Sponsor should be made aware of any off-site storage arrangements made by the site. If storage changes 

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before the limits of the retention period, the Investigative site is responsible for communicating those 
changes with the Sponsor. 
12.1.9 Protocol Deviations 
A protocol deviation is an Instance of failure to follow, intentionally or unintentionally, the requirements 
of the protocol (ISO 14155 Definition). The investigator is not allowed to deviate from the protocol without 
first receiving approval in writing from the Sponsor, involved EC, and applicable regulatory authorities. 
Deviations from the protocol to protect the rights, safety, and well-being of human subjects under 
emergency circumstances or situations beyond the investigator’s control (such as subjects not attending 
scheduled follow-up visits, etc. may proceed without prior approval of the sponsor and the EC. 
Approval for deviations shall be documented in writing and maintained in the investigator and clinical 
investigation files.  
The use of waivers from the protocol is prohibited. 
A Major Protocol Deviation is defined as an event that resulted in an increased risk to a subject or others; 
affected the right, safety, or welfare of a subject; or affected the scientific integrity of the clinical 
investigation. Major Protocol Deviations might include, but are not limited to, the following list:  
• 
Failure to obtain informed consent prior to subject enrollment  
• 
Enrolled subject did not meet the inclusion/exclusion criteria  
• 
Impacts subject safety or alters risks to subjects 
Any other events or omissions that do not comply with the requirements of the protocol will be 
considered Minor Protocol Deviations. Minor Protocol Deviations might include, but are not limited to, 
the following list:  
• 
Incorrect version of the informed consent form used.  
• 
Follow-up visit was outside the required window.  
All Major Protocol Deviations from the protocol must be reported promptly, but in no event later than 5 
business days, to the appointed Sponsor representative/clinical investigation monitor via e-mail, 
regardless of whether they were medically justifiable, pre-approved by the Sponsor or taken to protect 
the subject in an emergency. In addition, Investigators will also adhere to procedures for reporting 
deviations to the involved EC in accordance with their specific reporting policies and procedures. 
As a result of deviations, corrective actions are to be developed by the site and implemented promptly.  
Integra or its representatives will record and evaluate all deviations from the protocol during monitoring 
visits or when notified of the protocol deviation by the investigation site. Individual event corrective and 
preventive actions may be recommended at that time the deviations are recorded. In addition, deviations 
occurring across investigational sites will be reviewed by Integra on a periodic basis to determine if more 
global preventive actions may be required. 

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Subjects will receive standard of care in case a protocol deviation leads to the end, temporary halt, or 
early termination of the investigation. The standard of care is defined by the applicable treatment 
protocol(s) for the disease at the investigational site. 
12.1.10 Publications and Data Sharing Policy 
Publication and data sharing policies are contained within the Investigative site’s clinical trial agreement 
(CTA).  
Integra will register this study with public clinical investigation registries in accordance with applicable 
laws and regulations and will report the results of the study publicly in accordance with guidelines set by 
those registries. 
12.1.11 Conflict of Interest Policy 
The independence of this study from any actual or perceived influence, such as by the device industry, is 
critical. Therefore, and in accordance with an investigational site’s CTA, any actual conflict of interest (COI) 
of persons who have a role in the design, conduct, analysis, publication, or any aspect of this registry will 
be disclosed and managed by the Sponsor and their institution. Furthermore, persons who have a 
perceived COI will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this registry. It is incumbent upon the investigator to disclose 
COI to their respective facilities in accordance with their policies and procedures. 
 
 

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12.2 Abbreviations 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CMP 
Clinical Monitoring Plan 
COI 
Conflict of Interest 
CRAK 
Cranial Access Kit 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CSF 
Cerebrospinal Fluid 
CTA 
Clinical Trial Agreement 
DD 
Device Deficiency 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EDS 
External Drainage Sets 
EU 
European Union 
EVD 
External Ventricular Drainage 
GCP 
Good Clinical Practice 
ICP 
Intracranial Pressure 
IFU 
Instruction For Use 
ISO 
International Organization for 
Standardization 
IQR 
Interquartile Range 
ITT 
Intent-To-Treat 
MDCG 
Medical Device Coordination Group 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
OR 
Operating Room 
PMCF 
Post-Market Clinical Follow-Up 
PT 
Preferred Term 
QC 
Quality Control 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SKU 
Stock Keeping Unit 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
TBI 
Traumatic Brain Injury 
TMF 
Trial Master File 
USADE 
Unanticipated Serious Adverse Device effect 
VCAK 
Ventricular Drainage Accessory Kits 
YOB 
Year of Birth 

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12.3 
Protocol Amendment History 
Version 
Date 
Summary of Changes/Affected Sections 
Version 1.0 
 
N/A – First Version 
Version 2.0 
14-JUN-2022 
The primary endpoint clinical success has been defined, and the sample 
size has been recalculated per primary endpoint hypothesis.   
The Exclusion criteria 7 has been adjusted 
Version 3.0 
09-NOV-2022 
The Subgroup Analyses and Missing Data sections are updated. 
Version 4.0 
10-JUL-2023 
The safety objective was changed to collect safety data until the EVD 
system is no longer required and not limiting the timeframe to 30 days if 
the device was not removed in this timeframe. 
The primary endpoint was changed to better evaluate the safety and 
performance of the EVD system rather than the disease that being 
treated. 
The secondary endpoint was added to evaluate the successful access to 
the intracranial space. 
Version 5.0 
11-JUL-2024 
The inclusion cap was changed to 34% (40 subjects per site). 
The study duration at any individual site was changed to 25 months. 
Protocol section “12.1.9 Protocol Deviation” was amended in line with the 
Sponsor’s new procedures for recording protocol deviations. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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13 REFERENCES 
1. American Association of Neuroscience Nurses, Care of the Patient Undergoing Intracranial 
Pressure Monitoring / External Ventricular Drainage or Lumbar Drainage, in AANN Clinical 
Practice Guideline Series.  
2. Brain Trauma Association, Guidelines for the Management of Severe Traumatic Brain Injury, in 
Brain Trauma Association.  
3. Brain Trauma Foundation, Guidelines for the Management of Severe Traumatic Brain Injury, in 
Brain Trauma Foundation.  
4. Atkinson, R., et al., Silver-impregnated external-ventricular-drain-related cerebrospinal fluid 
infections: a meta-analysis. Journal of Hospital Infection, 2016. 92(3): p. 263-272. 
5. Yuen J, Selbi W, Muquit S, Berei T. Complication rates of external ventricular drain insertion by 
surgeons of different experience. Ann R Coll Surg Engl. 2018 Mar;100(3):221-225. doi: 
10.1308/rcsann.2017.0221. Epub 2018 Jan 24. PMID: 29364007; PMCID: PMC5930101. 
6. Mansoor N, Madsbu MA, Mansoor NM, Trønnes AN, Fredriksli OA, Salvesen Ø, Jakola AS, 
Solheim O, Gulati S. Accuracy and complication rates of external ventricular drain placement 
with twist drill and bolt system versus standard trephine and tunnelation: a retrospective 
population-based study. Acta Neurochir (Wien). 2020 Apr;162(4):755-761. doi: 10.1007/s00701-
020-04247-3. Epub 2020 Feb 4. PMID: 32020298; PMCID: PMC7066093. 
 
7. Chung DY, Olson DM, John S, Mohamed W, Kumar MA, Thompson BB, Rordorf GA. Evidence-
Based Management of External Ventricular Drains. Curr Neurol Neurosci Rep. 2019 Nov 
26;19(12):94. doi: 10.1007/s11910-019-1009-9. PMID: 31773310; PMCID: PMC7383112. 
 
 
 
 

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14 APPENDIX I 
 
14.1 
External Ventricular Drainage Systems included in this registry study 
Product Code 
Device/Part Name 
INS8401 
AccuDrain with Anti-Reflux Valve 
INS8400 
AccuDrain without the Anti-Reflux valve 
821731 
Codman EDS3 Drainage System without Ventricular Catheter  
821730C  
Codman External Drainage System 3 with Ventricular Catheter  
821731C 
Codman External Drainage System 3 without Ventricular Catheter  
NL850500V 
CSF Drainage System 
INS8600 
CSF Drainage System with Blue Stripe Tubing & 1-way V 
INS8601 
Hermetic External CSF Drainage System with pressure tubing 
INS8301 
Hermetic Plus EVD System with Reflux Valve 
INS9020 
LIMITORR VOLUME LIMITING EVD 20 ML 
INS9030 
LIMITORR VOLUME LIMITING EVD 30 ML 
10150 
MoniTorr CSF Drainage System Simple Bag and Line 
10110 
MoniTorr CSF Drainage System used with Pole Mount System 
INS1100 
MoniTorr CSF Drainage System used with Pole Mount System 
10100 
MoniTorr CSF Drainage System with Patient Line One Way Valve 
 
14.2 
External Ventricular Drainage Catheters included in this registry study 
Product Code 
Device/Part Name 
821735  
Codman Clear Ventricular CSF Catheter Kit  
82-1745 
Codman BACTISEAL EVD Catheter Set   
82-1749 
Codman BACTISEAL EVD Large Lumen Catheter Set  
82-1750 
Codman BACTISEAL Clear EVD Catheter Set  
INS4000 
Hermetic Ventricular Small Catheter Set 
INS4500 
Hermetic Large Style Ventricular Catheter Set 
INS8220 
Hermetic Catheter Set, 35CM 
INS8420 
TraumaCath, 35CM 
 
14.3 
Cranial Access included in this registry study 
Product Code 
Device/Part Name 
826617 
CODMAN CRANIAL ACCESS KIT With/Without 
826607 
 MicroSensor Hand Drill Disposable 
826608 
MicroSensor Drill Bit O 5.8mm Disposable 
 
 
 

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14.4 
External Ventricular Drainage Accessories included in this registry study 
Product Code 
Device/Part Name 
10210 
Drain Bag Replacement w/ Reflux Valve 
INS2100 
MoniTorr Drain Bag Replacement w/ Reflux Valve 
INS2101 
LimiTorr DRAINAGE BAG WITH ANTI REFLUX VALVE AND BLUE CAP 
821732C 
 EDS 3™ Collection Bag Kit - 5 Bags 
821733 
EDS 3™ Leveling Device 
INS8700 
701 ml Replacement Drainage Bag 
INS-301 
Integra® Pole Mount Sliding Bracket  
INS-400 
Evolution pole mount assembly with cm H2O and mm Hg Rail with Laser Level and Line Level 
INS-400CM 
Evolution pole mount assembly with cm H2O Rail, Laser Level and Line Level 
INS-410 
Evolution Pole Mount Assembly with cm H2O and mm Hg Rail with Laser Level and negative 
scale of -25 cm H2O/-18 mm Hg and Line Level 
INS-410CM 
Evolution Pole Mount Assembly with cm H2O Rail and negative scale of -25 cm H2O, Laser Level 
and Line Level 
INS-8903 
Line Level