A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Conditions: Peripheral Vascular Disease
Sponsor: Elutia Inc.

 
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PERFORM STUDY 
 
A POST MARKET OBSERVATIONAL STUDY ON THE USE OF 
CORMATRIX® ECM® FOR FEMORAL ARTERIAL RECONSTRUCTION 
 
 
STUDY SPONSOR: 
CORMATRIX CARDIOVASCULAR, INC. 
1100 OLD ELLIS ROAD 
ROSWELL, GA  30076 
 
PROTOCOL NUMBER:  14-PR-1120 
REVISION:  C 
 
 
 
                                                           
    January 11, 2016 
 
Please Note:  Confidential information contained herein is made available 
to you in your capacity as Investigator, Medical Advisor, or Consultant 
to CorMatrix Cardiovascular, Inc. (“CorMatrix”).  It is provided only for 
review by you, your staff, IRB/Ethics Committee members, or other 
regulatory authority.  Except as necessary to obtain properly 
informed consent for participation, it is expected that there will 
be no disclosure to other persons. 
 
 
Investigator Statement of Compliance 
I hereby agree to comply with this protocol and applicable regulations 
governing clinical trials, including local regulations, and Good Clinical 
Practice / ICH Guidelines. 
 
 
 
Investigator Signature: ___________________________________________                                           
 
Date: _________________________________________________________ 
 
 
 

 
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Table of Contents –  
TABLE OF CONTENTS – ........................................................................................................................ 2 
STUDY COORDINATION........................................................................................................................ 3 
1. 
INTRODUCTION AND RATIONALE ........................................................................................... 5 
2. 
INDICATION FOR USE ................................................................................................................... 5 
3. 
DESCRIPTION .................................................................................................................................. 5 
4. 
PRIOR CLINICAL EVALUATIONS .............................................................................................. 6 
5. 
STUDY OBJECTIVES ...................................................................................................................... 7 
6. 
STUDY DESIGN ................................................................................................................................ 7 
7. 
STUDY POPULATION ..................................................................................................................... 7 
8. 
STUDY PROCEDURES .................................................................................................................... 8 
9. 
ADVERSE EVENT REPORTING ................................................................................................... 9 
10.  DATA ANALYSIS ........................................................................................................................... 12 
11.  ETHICAL CONSIDERATIONS .................................................................................................... 12 
12.  BIBLIOGRAPHY ............................................................................................................................ 14 
APPENDIX A:  SAMPLE INFORMED CONSENT/PATIENT INFORMATION SHEET ............. 17 
APPENDIX B:  CASE REPORT FORMS ............................................................................................. 18 
APPENDIX C:  INSTRUCTIONS FOR USE ........................................................................................ 19 
APPENDIX D:  SPONSOR COMMITMENTS ..................................................................................... 20 
APPENDIX E:  INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES ..................... 21 
 
 
 
 
 
 

 
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CorMatrix Cardiovascular, Inc. 
 
 
 
STUDY COORDINATION 
 
 
 
 
 
STUDY SPONSOR 
CORMATRIX CARDIOVASCULAR, INC. 
1100 OLD ELLIS ROAD 
ROSWELL, GA  30076 
 
 
 
 
DATA COORDINATION 
CENTER 
 
CORMATRIX CARDIOVASCULAR, INC. 
1100 OLD ELLIS ROAD 
ROSWELL, GA  30076 
 

 
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Study Synopsis 
 
OBJECTIVE 
The objective of the study is to actively gather additional information on 
the use of CorMatrix ECM for vascular repair in the reconstruction of 
the femoral artery. 
STUDY 
POPULATION 
Up to 5 clinical sites will enroll up to 100 subjects who have received 
CorMatrix ECM for vascular repair.   
INDICATIONS FOR 
USE 
The CorMatrix® ECM® for Vascular Repair is intended for use as a 
patch material for repair and reconstruction of peripheral vasculature 
including the carotid, renal, iliac, femoral, and tibial blood vessels.  The 
CorMatrix ECM for Vascular Repair may be used for patch closure of 
vessels, as a pledget, or for suture line buttressing when repairing 
peripheral vessels. 
ENDPOINTS 
The endpoint is defined as the proportion of subjects with device related 
adverse events. 
EXAMINATION 
SCHEDULE 
The examination schedule is as follows:  Pretreatment/treatment, four to 
six weeks, six months and twelve months following femoral arterial 
reconstruction with the CorMatrix ECM for vascular repair. 
CLINICAL 
PARAMETERS 
The following clinical assessments will be performed: 
 Assess medical history at baseline 
 Assess medications at baseline and for changes at all 
follow up visits 
 Device related adverse event assessment at treatment, 4-6 
weeks, 6 months and 12 months 
 Duplex imaging at 4-6 weeks, 6 months and 12 months 
 
 

 
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1.  Introduction and Rationale 
 
Atherosclerosis and thrombosis are the main pathological processes involved in ischemic 
stroke, coronary heart disease and peripheral arterial disease.  The disease prevalence of 
systemic atherosclerosis is approximately 3% to 10%, increasing to 20% in persons aged 70 
years and older.  Femoral endarterectomy with patch angioplasty has been the favored 
approach to the treatment of patients with symptomatic common femoral artery (CFA) 
occlusive disease.  Primary patency rates of 74% to 91% at 5 years have been reported in the 
literature.  
 
The development of carotid patches, as well as patches for use in arteriotomy closure 
elsewhere, continues to remain a critical adjunct for vascular surgery.  The CorMatrix ECM 
for vascular repair is an attractive vascular patch material due to its ability to be remodeled 
into healthy native tissue.   
 
The CorMatrix ECM for Vascular Repair acts as a decellularized scaffold for use as a 
vascular patch to repair the peripheral vessels.  The extracellular matrix (ECM) scaffold is a 
biomaterial derived from porcine small intestinal submucosa (SIS).  The SIS is developed 
from a select layer of tissue that is recovered from porcine small intestine.  The 
decellularized ECM scaffold allows the patient’s own cells to migrate and attach within the 
ECM to naturally repair the tissue defect.  
 
CorMatrix Cardiovascular, Inc. received FDA 510(k) premarket clearance for the CorMatrix 
ECM for Vascular Repair on July 16, 2014.  This Phase IV, post market observational study, 
will evaluate the safety and effectiveness of CorMatrix ECM for femoral arterial 
reconstruction by collecting specific data at pretreatment, treatment, 4-6 weeks, 6 months and 
12 months following femoral arterial reconstruction with the CorMatrix ECM for vascular 
repair.  Data collected from this study will not be used to support a marketing claim or 
change in labeling.  This study is being performed to gather post-market data only and is not 
being performed under the direction of the FDA.     
2. Indication for Use  
 
The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair 
and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and 
tibial blood vessels.  The CorMatrix ECM for Vascular Repair may be used for patch closure 
of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.  The 
entire Instructions for Use can be found in Appendix C. 
3. Description  
 
The CorMatrix® ECM® for Vascular Repair is intended for use as a patch material for repair 
and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and 

 
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tibial blood vessels.  The CorMatrix ECM for Vascular Repair may be used for patch closure 
of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels. 
 
The CorMatrix ECM for Vascular Repair is an extracellular matrix (ECM) scaffold derived 
from porcine small intestinal submucosa (SIS).  The device is constructed of a multilaminate 
(6-ply), decellularized, non-crosslinked, lyophilized ECM cut to specific shapes and sizes 
and terminally sterilized using Ethylene Oxide gas.  The CorMatrix ECM for Vascular 
Repair will be supplied as a 6-ply, lyophilized, sterilized sheet of SIS-ECM. 
4. Prior Clinical Evaluations 
 
CorMatrix ECM has been studied in previous prospective clinical evaluation, and a post-
market clinical study is ongoing.  The ECM for Pericardial closure has been studied in a 
randomized, prospective study to evaluate its ability to reduce the incidence of new onset 
atrial fibrillation; the ECM for Carotid Repair is under evaluation in a post-market study to 
capture and assess device performance data from subjects undergoing patch angioplasty of 
the carotid artery following carotid endarterectomy using the product per its FDA-cleared 
Indications for Use.   
 
4.1 Post-market Clinical Evaluation of the ECM for Carotid Repair 
 
CorMatrix is currently conducting a post-market registry study for the CorMatrix ECM 
for Carotid Repair (Protocol No. 11-PR-1021).  The objective of this registry is to capture 
and assess device performance data from subjects undergoing patch angioplasty of the 
carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid 
Repair per its commercial Indications for Use.  This registry provides an ongoing post-
market surveillance mechanism to document clinical outcomes on the use of the 
CorMatrix ECM for Carotid Repair.  This is a multi-center, prospective, single-arm, post-
market, observational registry of subjects receiving the CorMatrix ECM for Carotid 
Repair for patch angioplasty following carotid endarterectomy procedures.  This post-
market registry may involve up to ten U.S. clinical sites and up to 230 subjects.  Data will 
be collected through the 24-month follow-up. 
One-hundred and eighty six patients are enrolled in the study and included in the interim 
analysis of the CorMatrix ECM for Carotid Repair registry.  The data demonstrated that 
the rate of device related adverse events were consistent with the rates found in the 
review of the contemporary literature for patch angioplasty.  Specifically, no 
unanticipated events were found and the rate of the events was as anticipated in the risk 
management plan.  Of specific interest in the analysis was the rate of pseudoaneurysm, 
which was present in 2 (1.08%) of the 186 patients and compared favorably to the rates 
found in the literature (1.4% to 5%). 
The mean carotid stenosis (maximum) at pre-operative was 85.5%.  Mean change from 
baseline values were -52.5%, -53.9%, -58.4%, and -45.2% at the 1- to 3-month, 6-month, 
12-month, and 24-month follow-up evaluations.  The mean carotid stenosis (minimum) at 
pre-operative was 72.5%.  Mean change from baseline values were -64.5%, -63.7%, -

 
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63.2%, and -60.4% at the 1- to 3-month, 6-month, 12-month, and 24-month follow-up 
evaluations.  
 
As a result of this analysis and the directed and ongoing risk management activities, the 
overall residual risk of the CorMatrix ECM for Carotid Repair is determined to be 
acceptable. 
5. Study Objectives 
 
The objective of the study is to actively gather additional information on the use of 
CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. 
 
Endpoint 
The endpoint is defined as the proportion of subjects with device related adverse events.   
6.  Study Design 
 
This is a multi-center, Phase IV, prospective, single arm, post-market observational study of 
subjects undergoing femoral arterial reconstruction using the CorMatrix ECM for vascular 
repair per its FDA cleared Indications for Use.  It is anticipated that up to 5 eligible sites will 
participate enrolling up to 100 subjects.  Eligible candidates will be approached to ascertain 
interest in study participation.  The approved Informed Consent and/or Patient Information 
Sheet will be completed and the process will be documented in the subject study binder by 
the research staff.  Patients who have undergone a femoral arterial reconstruction using the 
CorMatrix ECM will be followed as per their usual standard of care.  Information will be 
collected at follow up visits 4-6 weeks, 6 months and 12 months. 
7.  Study Population 
 
Subjects are considered to be enrolled into this study at the completion of their surgical 
procedure of femoral arterial reconstruction with the use of CorMatrix ECM.  Before any 
subject can be enrolled, the IRB for the specific institution must approve the protocol and the 
Informed Consent/Patient Information Sheet. 
 
Subjects must meet the following requirements to be eligible for enrollment in this study: 
 
Inclusion Criteria: 
 Subjects must be undergoing femoral arterial reconstruction with patch 
angioplasty closure. 
 Subject’s surgeon intends to use CorMatrix ECM as the patch material for 
femoral arterial reconstruction per its FDA cleared Indications for Use. 
 The subject must possess the ability to provide informed consent. 
 The subject must express an understanding and willingness to fulfill all of the 
expected requirements of this protocol. 
 

 
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Exclusion Criteria: 
 
 Known sensitivities to porcine material 
 
8.   Study Procedures 
 
Study procedures are standardized to the extent possible and explained in detail below 
and are summarized in Table I - Study Procedure Overview.   
 
All study-related data will be captured on standardized Case Report Forms.  A copy of 
the Case Report Forms is provided in Appendix B.  Case report forms will be sent to 
CorMatrix via fax at 678-990-2337 (attention S. Beall) or via scan/email to 
sbeall@cormatrix.com 
 
 
Table 1:  Study Procedure Overview 
Activity 
Pre-Tx 
Treatment 
Week 4-6 
Month 6 
Month 12 
Assess Eligibility 
X 
 
 
 
 
Informed Consent Process 
X 
 
 
 
 
Medical History/update 
X 
X 
X 
X 
X 
Medication history/update 
X 
X 
X 
X 
X 
Duplex Imaging 
X* 
 
X 
X 
X 
Surgical Complications 
 
X 
 
 
 
Assessment for Adverse 
Events 
 
X 
X 
X 
X 
Infection Information 
 
X 
X 
X 
X 
*Data captured if performed, not required  
 
8.1 Pre-Treatment Procedure 
 
Patients presenting for femoral arterial reconstruction with patch angioplasty will be screened for 
study eligibility.  Eligible candidates will be approached to ascertain interest in study 
participation.  Before any study specific tests are performed, the patient will have the details of 
the study fully explained and will sign an approved Informed Consent or, if Waiver of 
Documentation of Consent, patient will verbalize understanding.  The consent process will be 
documented by research personnel and the patient will be provided with a copy of the Informed 
Consent and/or Patient Information Sheet.  
 
A pretreatment visit will be conducted prior to surgery and for all subjects: 
 Documentation of the consent process  
 Demographic information 
 Medical history, including indication for surgery 
 Duplex Imaging, if performed 
 Relevant medications 

 
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8.2     Treatment Procedure 
 
The subject will undergo a standard femoral arterial interventional procedure.  The 
subject’s femoral arteriotomy will be closed using the CorMatrix ECM for arterial repair.  
The Investigator will implant the CorMatrix ECM according to the FDA cleared 
Instruction for Use and per the surgeon’s standard of care.  Specific data on the procedure 
as well as the CorMatrix ECM will be collected.  Device related adverse events will be 
documented on the case report form.   
 
8.3  
Post-operative  
 
The Investigator’s standard post-operative procedures will be followed.  Post-operative 
data from the end of the procedure until the subject is discharged from the hospital will 
be collected and includes length of hospital stay, medications upon discharge and any 
complications/adverse events. 
 
 
8.4   Follow up  
 
Follow up assessments will be conducted at the 4-6 Week, 6 Month and 12 Month follow 
up visit per Table I - Study Procedure Overview.  Data will be collected on the 
appropriate case report form. 
9. Adverse Event Reporting  
 
9.1 Definitions 
 
Adverse Event (AE)  
An adverse event (AE) will be defined as any undesirable clinical occurrence in a subject 
whether it is considered to be device related or not, that includes a clinical sign, 
symptom, or condition/observation of an unintended technical performance or 
performance outcome of the device.  Causality is defined as not-related, possibly-related 
and probably-related to the device, which is further defined in Table 2:  Event 
Relationship Assessment.   
 
 
Serious Adverse Event (SAE) 
A serious adverse event (“SAE”) will be defined as an event that:  1) threatens life, 2) 
results in permanent impairment of a body function or permanent damage to a body 
structure, 3) necessitates medical or surgical intervention to preclude such impairment, 4) 
requires or prolongs hospitalization, or 5) is fatal (death). 
 
Adverse Device Event 
An Adverse Device Event will be defined as a clinical sign, symptom, or condition that is 
causally related to the device procedure, the presence of the device, or the performance of 
the device.  Due to the temporal proximity of the AE to product administration, there is a 

 
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reasonable possibility that the product may have caused the AE or may have contributed 
to the severity or duration of an event caused by other means.   
 
 
Table 2:  Event Relationship 
AE Relationship 
Description 
Not-related 
A temporal relationship to the use of the product, which makes a 
causal relationship clearly and incontrovertibly due to extraneous 
causes, such as other drugs, products, chemicals, underlying 
diseases, environment, etc.  Not-related to the use of the product. 
Possibly-related 
Occurring within a reasonable period of time relative to the use of 
the product, which makes a causal relationship possible, but 
plausible explanations may also be provided by other causes, 
such as other drugs, products, chemicals, underlying disease, 
environment, etc.  Possibly-related to the use of the product. 
Probably-related 
Occurring within a reasonable period of time relative to use of 
product, which makes a causal relationship probable where the 
relationship cannot be attributed to other causes, such as drugs, 
products, chemicals, underlying disease, environment, etc. 
Probably-related to the use of the product. 
 
9.2 
Assessing and Recording Adverse Events 
 
Each AE recorded must be documented on the Case Report Form.  All serious and device 
related events must be reported immediately to CorMatrix via telephone or email within 
24 hours of the Investigator becoming aware of the event.  The case report form will be 
submitted to CorMatrix.  The site will be contacted by CorMatrix for additional 
information including, but not limited to: 
 
 Description of the event and underlying cause (diagnosis), coexisting disease, or 
other.  In order to avoid vague, ambiguous, or colloquial expressions, the AE 
should be recorded in standard medical terminology rather than the subject’s own 
words when possible. 
 Date of onset and date of resolution.  If the event is present at the Month 12 
follow-up visit it will be marked as not resolved at study exit. 
 Intensity of the event:  mild, moderate, or severe. 
 Frequency of the event:  single episode, intermittent, or continuous. 
 Action taken:  none, medication, procedure, medication and procedure, or other.   
 Relationship to the study treatment:  not-related, possibly-related, or probably-
related.  
 
Any subject withdrawn from the study due to an AE will be followed until the outcome 
of the event is determined.  The Investigator must ensure that the details of the event are 
documented in the medical notes including full details of the outcome, in addition to 
recording the event on the appropriate case report form. 
 

 
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All femoral procedure and device related serious adverse events that are associated with 
the use of the device will be evaluated in accordance with the protocol and the Sponsor’s 
Incident/Event Reporting SOP.  Any serious adverse event that requires a Medical 
Device Report will be reported by the Sponsor to the FDA in accordance with Sponsor’s 
Medical Device Reporting SOP.  The site should contact: 
 
Stephanie Beall 
Project Administrator, CorMatrix 
(470) 514-4031 (direct) 
(678) 566-2628 (company) 
sbeall@cormatrix.com 
9.3 
Possible Adverse Events 
 
The following possible adverse events have been identified as possible risks from the 
CorMatrix ECM: 
 
• Acute or chronic inflammation (Initial application of the CorMatrix ECM may be 
associated with transient, mild, localized inflammation.)  
• Allergic reaction  
• Bleeding  
• Embolization of ECM  
• Infection (superficial or deep) 
• Patch dehiscence  
• Pseudoaneurysm  
• Recurrent stenosis  
• Stroke  
• Thrombosis  
• Vessel occlusion  
 
The following possible adverse events have been identified as possible risks from the 
surgical procedure: 
 
 Reactions to anesthesia 
 Bleeding 
 Infection 
 Nerve damage (skin numbness) 
 Blood clots 
 Hematoma 
 Leg swelling 
 Re-stenosis 
 
This study will capture events reported at treatment, post-operatively, 4-6 Weeks, 6 
months and 12 months follow up and as reported by the PI and/or subject and from a 
review of medical records.    

 
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10. Data Analysis   
Since this is a Phase IV, post-market study, analyses will consist of tabulated data and 
descriptive statistics.  Subject data listings and tabular and graphical presentations of the 
summary and statistical results will be provided.  At a minimum, an interim report will be 
completed after 50 subjects have completed their four to six week follow-up.  A final 
report will be completed at the end of the study.  Additional quantitative and qualitative 
comparisons will be made to contemporary literature and similar studies.  
11. Ethical Considerations 
 
11.1 Code of Conduct 
 
The Investigator will ensure that the clinical study is conducted in accordance with good 
clinical practice and all regulatory and institutional requirements, including those for 
subject privacy, Institutional Review Board or Ethics Committee approval, and record 
retention.  (Appendix E:  Investigator Qualifications and Responsibilities) 
 
11.2 Ethics Committee / Institutional Review Board Approval and Oversight 
 
The Investigator must obtain appropriate Ethics Committee (“EC”) or Institutional 
Review Board (“IRB”) approval before the study can be initiated.  A copy of the written 
approval from the EC/IRB and a copy of the Informed Consent/Patient Information Sheet 
should be sent to CorMatrix.  Appropriate study progress reports will be prepared for the 
EC/IRB by the Principal Investigator.  Any changes to the protocol must be discussed 
and approved by CorMatrix in writing unless the change is made to assure the safety of 
the subject.  In the non-emergent setting, after agreement on the changes has been 
reached, an amendment to the protocol will be provided by CorMatrix for submission to 
the EC/IRB for review and approval prior to initiation of the change.  Any change made 
emergently must be documented in the subject's medical record.  The Investigator must 
immediately forward to the EC/IRB any written safety reports or updates from 
CorMatrix.   
 
11.3 Informed Consent Process and Subject Confidentiality 
 
The investigator will be responsible for submitting the clinical study protocol and an 
Informed Consent or Patient Information Sheet (Waiver of Documentation of the 
Informed Consent Process) to their EC/IRB or centralized EC/IRB.  The protocol, 
Informed Consent/Patient Information Sheet and the waiver must be approved by the 
local/centralized EC/IRB before the study is initiated and subjects enrolled.  
 
Prior to obtaining any study specific information the approved Informed Consent must be 
signed and/or the Patient Information Sheet must be reviewed with the subject and the 
subject must provide verbal approval.  Documentation of the consent process must be 
completed by the research personnel.  The investigator shall provide a copy of the 
Informed Consent/Patient Information Sheet to the subject.  Completed documentation of 

 
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the consent process will be available for auditing by CorMatrix or their representative, as 
applicable.   
 
According to 45 CFR 46.117(c)(2) and 21 CFR 56.109 (c)(1), an IRB may waive the 
requirement for the investigator to obtain a signed consent form if: 
 
a) The research presents no more than minimal risk of harm to participants and 
b) The research involves no procedures for which written consent is normally 
required outside of the research context. 
 
 
CorMatrix will maintain the confidentiality of the identity of subjects enrolled in the 
study and the information contained in their study records.  CorMatrix will also instruct 
the study investigators in the importance of maintaining the confidentiality of study 
records.  Any publication of any data collected as part of this trial will only use de-
identified data, so that identification of any individual subject will not be possible.  The 
records will be made available as required for review by the FDA, or other applicable 
regulatory agency and a reviewing EC/IRB; however to the extent possible, the subject’s 
identity will not be disclosed.  The Case Report Forms will use a subject identification 
number, with the patient name and address NOT appearing anywhere on the study form 
to be submitted to the sponsor (Appendix D:  Sponsor’s Commitments). 
 
11.4. Clinical Study Monitoring 
 
Study monitors qualified by training and experience will be responsible for monitoring 
and overseeing the conduct of this study.  The Investigator shall cooperate with the study 
monitor designated by CorMatrix.  This includes, but is not limited to, allowing the 
inspection of facilities utilized by the investigator for this clinical investigation, providing 
access to subject medical records for auditing and verification purposes, providing all 
required reports, and providing all other reports, including any subject report forms 
reasonably requested.  The investigator, at reasonable times, shall also permit an 
authorized officer or employee of applicable regulatory agencies to inspect the facilities 
utilized by the investigator for the clinical investigation.  The investigator will also permit 
this representative to inspect, copy, and verify records required as part of or relevant to 
the investigation. 
 
 
Phone contacts and site visits will be conducted to ensure the protocol is being followed 
and all regulatory requirements are complete. Subject data will be reviewed and/or 
audited and all deficiencies corrected on site, if possible.  A complete report will be made 
of all monitoring visits.  When the study is terminated, a monitor will visit the site to 
ensure that all records are provided. 
 
The monitor will review the study conduct to determine compliance with the study 
protocol Good Clinical Practice guidelines.   
 

 
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12. Bibliography  
 
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Materials in Patients with Endocarditis. Thorac Cardiovasc Surg. 2014; 62(1):76-79. 
 
Toyoda Y, Kashem MA, Hisamoto K, Shiose A Tricuspid valve reconstruction with the 
extracellular matrix tube technique: A word of caution. J Thorac Cardiovasc Surg. 2014; Epub 
ahead of print. 
 
Deorsola L, Pace Napoleone C, Abbruzzese PA Repair of an unusual aortic coarctation using an 
extracellular matrix patch. Ann Thorac Surg. 2014; 97(3):1059-1061. 
 
Szczeklik M, Gupta P, Amersey R, Lall KS Reconstruction of the Right Atrium and Superior 
Vena Cava with Extracellular Matrix J Card Surg. 2014 
 
Zaidi AH, Nathan M, Emani S, Baird C, Del Nido PJ, Gauvreau K, Harris M, Sanders SP, 
Padera RF Preliminary experience with porcine intestinal submucosa (CorMatrix) for valve 
reconstruction in congenital heart disease: Histologic evaluation of explanted valves J Thorac 
Cardiovasc Surg. 2014;Epub ahead of print. 
 
Yanagawa B, Rao V, Yau TM, Cusimano RJ Potential myocardial regeneration with CorMatrix 
ECM: A case report. J Thorac Cardiovasc Surg. 2014; Epub Ahead of Print. 
 
Wallen J, Rao V Extensive Tricuspid Valve Repair After Endocarditis Using CorMatrix 
Extracellular Matrix Ann Thorac Surg. 2014;97(3):1048-1050. 
 
Cua CL, Kollins K, McConnell PI Echocardiographic Analysis of an Extracellular Matrix 
Tricuspid Valve. Echocardiography. 2014 
 
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Repair in a 90-Year-Old Woman Ann Thorac Surg. 2014; 97(5):e129-e131. 
 
Witt RG, Raff G, Van Gundy J, Rodgers-Ohlau M, Si MS Short-term experience of porcine 
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Surg. 2013; 44(1):72-76. 
 
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 Yeen WC, Faber C, Caldeira C, Nallamshetty L, Haddad T, Rolfe M Reconstruction of 
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Using CorMatrix Extracellular Matrix. Innovations (Phila). 2013; 8(5):348-352. 
 
Stelly M, Stelly TC. Histology of CorMatrix Bioscaffold 5 Years After Pericardial Closure. Ann 
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ahead of print Gerdisch MW, Shea RJ, Barron MD 
 
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treatment of mitral valve diseaseJ Thorac Cardiovasc Surg. 2013;Epub ahead of print. 
 
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90 Year-old Female.Ann Thorac Surg. 2013. 
 
Dearani JA, Said SM, O'Leary PW, Burkhart HM, Barnes RD, Cetta F. Anatomic repair of 
Ebstein's malformation: lessons learned with cone reconstruction. Ann Thorac Surg. 2013; 
95(1):220-6; discussion 226. 
 
Poulin F, Horlick EM, David T, Woo A, Thavendiranathan P. 3-Dimensional transesophageal 
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with extracellular matrix patch. J Heart Valve Dis. 2012; 21(1):138-139. 
 
Sundermann SH, Biefer HR, Emmert MY, Falk V. Use of Extracellular Matrix Materials in 
Patients with Endocarditis.Thorac Cardiovasc Surg. 2012;Epub ahead of print. DOI: 10.1055/s-
0032-1328920 
 
Smith CR, Stamou SC, Boeve TJ, Hooker RC. Repair of a penetrating ascending aortic ulcer 
with localized resection and extracellular matrix patch aortoplasty. Ann Thorac Surg. 2012; 
94(3):988-989. 
 
Chalajour F, Barboza LA, Boni L et al. Reconstruction of pulmonary artery in a newborn using a 
porcine small intestinal submucosal patch. Ann Thorac Surg. 2012; 93(4):1311-1315. 
 
Mavroudis CD, Casillan A, Rabbat M et al. Primary Intimal Sarcoma of the Pulmonary Vein 
with Extension into the Left Atrium: A Case Report. Open Journal of Thoracic Surgery. 2012; 
2(2):25-28. 
 

 
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Tweddell JS, Mitchell ME, Woods RK, Spray TL, Quintessenza JA. Construction of the Right 
Ventricle-to-Pulmonary Artery Conduit in the Norwood: The "Dunk" Technique. Operative 
Techniques in Thoracic and Cardiovascular Surgery. 2012; 17(2):81-98. 
 
Boyd WD, Tyberg JV, Cox JL. A review of the current status of pericardial closure following 
cardiac surgery. Expert Rev Cardiovasc Ther. 2012; 10(9):1109-1118. 
 
Quarti A, Nardone S, Colaneri M, Santoro G, Pozzi M. Preliminary experience in the use of an 
extracellular matrix to repair congenital heart diseases. Interact Cardiovasc Thorac Surg. 2011; 
13(6):569-572. 
 
Gerdisch MW, Akinwande AO, Matheny RG. Use of a novel acellular xenograft as a patch for 
aortic annular enlargement during aortic valve replacement. Innovations. 2010; 5(1):60-62. 
 
Scholl FG, Boucek MM, Chan KC, Valdes-Cruz L, Perryman R. Preliminary experience with 
cardiac reconstruction using decellularized porcine extracellular matrix scaffold: human 
applications in congenital heart disease. World Journal for Pediatric and Congenital Heart 
Surgery. 2010; 1(1):132-136. 
 
Boyd WD, Johnson WE, Sultan PK, Deering TF, Matheny RG. Pericardial reconstruction using 
an extracellular matrix implant correlates with reduced risk of postoperative atrial fibrillation in 
coronary artery bypass surgery patients. Heart Surg Forum. 2010; 13(5):E311-E316. 
 
Piterina AV, Cloonan AJ, Meaney CL et al. ECM-based materials in cardiovascular applications: 
Inherent healing potential and augmentation of native regenerative processes. Int J Mol 
Sci. 2009; 10(10):4375-4417. 
 
 

 
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Appendix A:  Sample Informed Consent/Patient Information Sheet 
(to be provided as separate documents) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix B:  Case Report Forms 
(to be provided as a separate document) 
 
 

 
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Appendix C:  Instructions for Use 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix D:  Sponsor Commitments 
 
 
CorMatrix is committed to: 
1. Complying with the Declaration of Helsinki and all applicable health authority 
regulations governing the conduct of clinical research studies. 
2. Protecting the rights, health, safety and welfare of study subjects. 
3. Informing the clinical investigators of any new information about the study which may 
affect the health, safety, or welfare of the subjects, or may influence their decision to 
continue participation in the study. 
4. Providing the clinical investigators with the study protocol and Case Report Forms on 
which to document the study evaluation variables for each subject entered into the study. 
5. Providing the clinical investigators and study staff training on the protocol and 
completion of the Case Report Form. 
6. Providing the statistical analysis and study report writing resources necessary to complete 
reporting of the study results. 
7. Certifying that EC/IRB approval of the protocol and Investigators Agreement will be 
completed prior to treatment at a clinical site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix E:  Investigator Qualifications and Responsibilities 
 
Each investigator must be a licensed physician who has received training for using the CorMatrix 
ECM for Vascular Repair.  The investigators have the following responsibilities: 
 
1. Subject Selection 
The investigator is responsible for assuring that all subjects entering the study are eligible to 
participate. 
 
2. Ethics Committee (EC)/Institutional Review Board (IRB) Approval 
The investigator must obtain approval for his participation in this protocol from an EC/IRB 
prior to entering any patients in the study.  Assurance that the EC/IRB approval of the study 
protocol and Informed Consent and/or Waiver of Documentation of Consent has been obtained 
will be provided to the Sponsor prior to initiation of the study. 
 
3. Subject Evaluation and Data Reporting 
The investigator is responsible for performing the patient evaluations as described in the 
study protocol.  All information generated by the patient evaluation will be recorded on the 
Subject Case Report Forms provided by the Sponsor.  The Case Report Forms will be filled 
out in black ink.  Any corrections will be made by lining out with a single line, providing the 
date of corrections and initials of person making the correction.  Correction fluid will not be 
used.  The Investigator will sign and date the forms and will send the form via fax / email to 
CorMatrix.  Copies of all Case Report Forms will be retained in the Investigator's office in 
order to be available for monitoring by CorMatrix personnel or by authorized regulatory 
agencies.  
 
Investigator(s) will not deviate from the protocol without prior approval of CorMatrix unless 
protection of the health, safety or welfare of study subjects requires prompt attention. 
 
4. Record Retention 
The Investigator must retain all subject records for at least 2 years, or longer, if required by 
local regulations.