Postmarket Registry for Evaluation of the Superion® Spacer
Conditions: Lumbar Spinal Stenosis
Sponsor: Boston Scientific Corporation

 
 
 
Postmarket Registry for Evaluation of the Superion® Spacer 
[PRESS Registry] 
 
Protocol No.:  16-VISS-01 Rev C 
 
July 20, 2016 
 
 
 
 
 
Sponsor: 
Vertiflex®, Inc. 
1351 Calle Avanzado, Suite 100 
San Clemente, CA  92673 
 
 
 
 
 
 
 
 
This document is a confidential communication of Vertiflex®, Inc. The recipient agrees that no 
unpublished information contained herein will be published or disclosed without prior written 
approval of Vertiflex®, Inc. except that this document may be disclosed to appropriate ethics 
committees or duly authorized representatives of the U.S. Food and Drug Administration or other 
responsible regulatory authorities under the condition that confidentiality is maintained. 
 
 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
Vertiflex®, Inc. 
 
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INVESTIGATOR SIGNATURE PAGE 
 
Title: 
Postmarket Registry for Evaluation of the Superion® Spacer 
 
[PRESS Registry] 
 
Protocol No.: 16-VISS-01 
 
Date: 
July 20, 2016 
 
 
By signing this page, the Investigator acknowledges that: 
He/she has read the protocol and agrees to comply with the protocol in accordance with Good 
Clinical Practices and use of the stipulated products as indicated in the protocol. 
All patients will provide signed Informed Consent (provided by Sponsor) prior to enrollment in 
the registry. 
Where/if applicable, Investigator agrees to conform to all procedures agreed to, or required by, the 
Institutional Review Board or Independent Ethics Committee. 
All data relevant to the clinical evaluation and regarding the subject response and safety, as 
stipulated in the protocol, will be documented and provided to the Sponsor. 
All unanticipated adverse device effects, and serious adverse device events that are definitely 
device- or procedure-related, will be reported as requested to the Sponsor within 24 hours. 
 
 
 
 
 
 
Signature of Investigator 
 
Date 
 
 
 
 
Printed Name of Investigator 
 
 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
Vertiflex®, Inc. 
 
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TABLE OF CONTENTS 
Investigator Signature Page 
2 
Table of Contents 
3 
Protocol Synopsis 
4 
1 PURPOSE 
5 
2 PRODUCT DESCRIPTION 
5 
 
2.1 
Device Description 
5 
 
2.2 
Indications for Use 
6 
3 POSTMARKET SURVEILLANCE PROCEDURES 
6 
 
3.1 
Registry Design 
6 
 
3.2 
Registry Endpoints 
6 
 
3.3 
Duration and Extent of Registry 
7 
 
3.4 
Registry Population & Source of Patients 
7 
 
3.5 
Registry Procedures 
7 
 
 
3.5.1 
Pre-Operative Assessment 
7 
 
 
3.5.2 
Intra-Operative Assessment 
8 
 
 
3.5.3 
Post-Operative Follow-Up Assessments 
8 
4 SERIOUS ADVERSE EVENTS 
9 
 
4.1 
Serious Adverse Events 
9 
5 TERMINATION OF PARTICIPATION 
9 
6 DEVICE EXPLANT AND RETRIEVAL 
10 
7 INVESTIGATOR RESPONSIBILITIES 
10 
8 SPONSOR OBLIGATIONS 
10 
 
8.1 
Investigator(s) Training 
10 
 
8.2 
Sponsor Registry Termination 
10 
 
8.3 
Registry Monitoring 
10 
9 LIST OF APPENDICES 
10 
 
 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
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Postmarket Registry for Evaluation of the Superion® Spacer 
[PRESS Registry] 
Protocol No. 16-VISS-01 
 
PROTOCOL SYNOPSIS 
 
Title 
Postmarket Registry for Evaluation of the Superion® Spacer 
Short Title 
PRESS Registry 
Protocol Number 
16-VISS-01 
Sponsor 
Vertiflex® Inc. 
1351 Calle Avanzado, Suite 100 
San Clemente, CA 92673 
Registry Treatment 
Superion® Indirect Decompression System (IDS) 
Control Treatment 
None 
Registry Design 
Prospective, single arm, multi-center 
Registry Objective 
The purpose of this postmarket surveillance registry is to gather 
evidence documenting the performance and clinical outcomes 
associated with treatment of moderate degenerative lumbar spinal 
stenosis using the Superion® Indirect Decompression System (IDS) . 
Registry Population 
Patients ≥45 years of age suffering from symptoms of neurogenic 
intermittent claudication secondary to a confirmed diagnosis of 
moderate degenerative lumbar spinal stenosis at one or two contiguous 
levels from L1 to L5. 
Number of Subjects 
A minimum of one hundred (100) patients will be enrolled in the 
registry. 
Number of Sites 
A minimum of twenty (20) sites will participate. 
Registry Enrollment 
Approximately 12 months for a minimum of 100 patients. 
Registry Duration 
Patients included in the clinical registry will return for follow-up visits 
at 3 weeks, and 6 and 12 months post-treatment to collect data for the 
primary evaluation.  Registry duration is approximately 24 months 
based upon 12 months’ enrollment plus 12 month follow-up for 100 
patients.  Sponsor reserves the right to enroll additional patients. 
Endpoints 
 VertiFlex® Patient Satisfaction Survey:  A score of ≥3 in each 
questionnaire component is considered clinically significant; 
 Visual Analogue Scale (VAS):  An improvement in back and leg 
pain of 20 mm (on a 100 mm scale) vs. baseline is considered 
clinically significant. 
 Achievement of Self-Defined Functional Objective.  A score of ≥3 
is considered evidence of significant improvement in function. 
Other Data Collected 
 Reports of serious procedure- or device-related adverse events; 
 Intraoperative metrics including estimated blood loss, operative time, 
type of anesthesia, and time to discharge. 
 
 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
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1 
PURPOSE 
The purpose of this postmarket registry is to gather evidence documenting the performance and 
clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using 
the Superion® Indirect Decompression System (IDS). 
2 
PRODUCT DESCRIPTION 
The Superion® Indirect Decompression System (IDS) (Superion® implant) is a spinal implant 
designed to treat symptoms of neurogenic intermittent claudication secondary to moderate 
degenerative lumbar spinal stenosis, and is implanted by minimally-invasive methods through a 
cannula with patient under general or local anesthesia.  The implant provides indirect 
decompression of spinal nerves, and functions as a spinal extension-blocker to prevent 
compression of neural elements in extension.  The device was approved by the U.S. Food and Drug 
Administration (FDA) for commercialization in the U.S. via PreMarket Approval (PMA) on May 
20, 2015.1 
2.1 
Device Description 
The Superion® implant is available in five (5) sizes, from 8mm to 16mm in 2mm increments, to 
accommodate a range of spinal anatomy.  It is composed of Titanium 6Al-4V alloy conforming to 
ASTM Standard Specification F136, Standard Specification for Wrought Titanium-6 Aluminum-4 
Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.  Figure 1 depicts 
the implant in its final position after placement between the spinous processes. 
Figure 1: Superion® Indirect Decompression System (IDS) in situ 
 
 
Lateral View 
A/P View 
 
 
 
1For a complete Summary of Safety and Effectiveness Data (SSED) derived from the clinical trial supporting FDA 
approval of the Superion® PMA, please refer to the SSED posted on the FDA website at 
http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140004b.pdf. 
 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
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The device may be implanted under general or local (e.g., conscious sedation) anesthesia.  A 
percutaneous or mini-open approach is used for placement of a cannula via sequential dilation.  A 
sizing tool is employed to determine the proper device size, and the Superion® implant is then 
inserted through the cannula and deployed under fluoroscopic guidance between spinous processes 
at the level to be treated.  The implant serves thereafter to maintain distraction between the spinous 
processes while preserving motion.  This maintains the intervertebral space and prevents 
narrowing of the canal by limiting extension at that level.  Where a second, contiguous level is 
also symptomatic, the same procedure is used to place a Superion® implant at that level. 
2.2 
Indications for Use 
Patients will conform to indications and contraindications delineated in the Superion® labeling. 
3 
POSTMARKET SURVEILLANCE PROCEDURES 
3.1 
Registry Design 
The PRESS registry is a prospective, single arm, multi-center registry intended to collect clinical 
experience with use of the Superion® Indirect Decompression System (IDS) in the treatment of 
moderate degenerative lumbar spinal stenosis.  A minimum of twenty (20) sites will be selected to 
participate, enrolling a minimum of one hundred (100) patients. 
Patient selection will conform to labeled indications for use, and physicians will treat patients in 
accordance with physician labeling and the Superion® Surgical Technique Manual.  All physicians 
must have completed training in the use of the device provided by Vertiflex®. 
3.2 
Registry Endpoints 
Registry endpoints will include the following outcomes reflective of clinical effectiveness: 
 Vertiflex® Patient Satisfaction Survey:  A score of ≥3 in each questionnaire component 
will be deemed a clinically meaningful outcome. 
 Visual Analogue Scale (VAS), Back and Leg Pain:  An improvement of 20 mm (on a 100 
mm scale) from baseline is considered a clinically meaningful outcome. 
 Achievement of Self-Defined Functional Objective.  A score of ≥3 is considered evidence 
of significant improvement in function. 
In addition, other information to be collected will include: 
 Reports of Serious Adverse Events (SAEs) determined by the Investigator to be definitely 
procedure- or device-related. 
Perioperative information that will be collected includes: 
 Type of anesthesia 
 Operative time (min.) 
 Estimated blood loss (cc) 
 Time to discharge (hrs.) 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
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3.3 
Duration and Extent of Registry 
Patients included in this registry will be assessed pre-operatively for eligibility in accordance with 
labeled indications for use, and will return for follow-up visits at 3 weeks (±2 weeks), 6 months 
(±2 months), and 12 months (±2 months) post-treatment.  Designed to enroll a minimum of one 
hundred (100) patients, Vertiflex® may elect to enroll additional patients. 
3.4 
Registry Population and Source of Patients 
The registry population will consist of male and female patients ≥45 years of age, with symptoms 
of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative 
lumbar stenosis at one or two contiguous levels from L1 to L5, meeting the labeled indications for 
use of the Superion® Indirect Decompression System (IDS) .  Patients will be identified and 
recruited by treating clinicians and/or their designated research staff.  The clinician Investigator at 
each site is responsible for verifying that a potential registry patient meets all eligibility criteria, as 
described in the labeled indications for use, and is not contraindicated. 
Patients will be considered evaluable after Informed Consent has been signed, the Investigator has 
verified eligibility, and Vertiflex® has assigned a unique patient identifier number. 
3.5 
Registry Procedures 
Data will be collected from all patients participating in the registry pre-operatively, intra-
operatively, and at follow-up visits at 3 weeks (±2 weeks), 6 months (±2 months), and 12 months 
(±2 months) post-treatment (See Visit Schedule, Appendix A).  Data will be recorded on approved 
Case Report Forms provided by Vertiflex®.  Procedures associated with individual visits are as 
follows: 
3.5.1 Pre-Operative Assessment 
The following information will be collected and documented on the Pre-Operative Assessment 
Case Report Form (Appendix B) by the Investigator or his/her authorized clinical research staff at 
the time of pre-operative assessment: 
 
Confirmation of Eligibility 
All potential registry participants shall be confirmed as meeting eligibility requirements, 
as described in labeled indications for use and contraindications. 
 
Informed Consent 
All patients seeking to participate in the registry, and whose eligibility has been confirmed 
by the Investigator, will be required to sign Sponsor-provided Informed Consent prior to 
enrollment. 
Demographic Information 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
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Date of birth, gender, height, weight, and smoking history will be collected. 
Establishment of Self-Defined Functional Objective 
3.5.2 Intra-Operative Assessment 
Perioperative metrics will be collected and documented on the Treatment Case Report Form 
(Appendix B) at the time of treatment, including: 
 Device size(s) 
 Device lot number(s) 
 Surgical level(s) treated 
 Type of anesthesia 
 Duration of surgery (min.), measured from start of anesthesia administration to completion 
of skin closure 
 Estimated blood loss (cc) 
 Time to discharge (hrs.), measured from completion of skin closure to discharge from 
treating facility 
In addition, any intra-operative complications/serious adverse events deemed by the Investigator 
to be definitely procedure- or device-related will be documented, as described in §4. 
3.5.3 Post-Operative Follow-Up Assessments 
At each follow-up visit, i.e., at 3 weeks (±2 weeks), 6 months (±2 months), and 12 months (±2 
months) post-treatment, the following information will be collected and documented on the 
Follow-Up Visit Case Report Form (Appendix B): 
 Patient identification number and initials, and date of follow-up visit and follow-up interval 
(e.g., 3 weeks, 6 or 12 months, etc.) will be recorded by the Investigator and/or his/her 
authorized clinical research staff. 
 Patients will complete a Vertiflex® Patient Satisfaction Survey.  A score of ≥3 in each 
questionnaire component will be deemed a clinically meaningful outcome. 
 Patients will complete a Visual Analogue Scale (VAS) for each leg, and for back pain.  An 
improvement of 20 mm (on a 100 mm scale) from baseline is considered a clinically 
meaningful outcome. 
 Patients will indicate the extent to which they have achieved their Self-Defined Functional 
Objective, on a 1 to 5 scale, with 1 indicating no progress at all, and 5 indicating complete 
achievement. 
In addition, the Investigator and/or his/her authorized clinical research staff will collect and 
document: 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
20 July 2016 
 
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 Reports of any Serious Adverse Events (SAEs) occurring since the last visit, and 
determined by the Investigator to be definitely procedure- or device-related. 
 
4 
SERIOUS ADVERSE EVENTS (SAEs) 
All Serious Adverse Events (SAEs) deemed by the Investigator to be definitely procedure- or 
device-related must be documented on the SAE Case Report Form (Appendix B). 
4.1 
Serious Adverse Events 
An adverse event is regarded as a Serious Adverse Event (SAE) if the injury or illness: 
A) Results in death 
B) Is life-threatening, 
C) Results in or prolongs hospitalization 
D) Results in permanent impairment of a body function or permanent damage to a body 
structure, or 
E) Necessitates medical or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. 
The Vertiflex® Clinical Research group must be notified of all Serious Procedure- or Device-
Related Adverse Events within 24 hours at: 
Vertiflex®, Inc., Clinical Research 
1351 Calle Avanzado, Suite 100 
San Clemente, CA 92673 USA 
Tel:  
(866) 355-4675 
Fax: (949) 940-1475 
clinical@vertiflex.net 
5 
TERMINATION OF PARTICIPATION 
Patients may voluntarily withdraw from the registry at any time for any reason.  The Investigator(s) 
may elect to withdraw a subject from the registry at any time due to lack of compliance or for any 
reason unrelated to the registry treatment if such a decision is in the patient’s best medical interest. 
6 
DEVICE EXPLANT AND RETRIEVAL 
In the event of a device removal, the device and the Investigator’s written explanation of the event 
will be sent to Vertiflex® following instructions from Vertiflex®. 
 
7 
INVESTIGATOR RESPONSIBILITIES 
Investigators will be deemed responsible for the following: 

Vertiflex®, Inc., PRESS Registry 
Protocol #: 16-VISS-01 Rev C 
 
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 This registry must have initial and continuing approval (at least annually) from an 
Institutional Review Board (IRB) responsible for approving clinical studies. 
 Acquisition of signed Informed Consent from each patient before performing any registry-
related activities. 
 Conduct of the registry in conformance with this protocol, and with Good Clinical 
Practices. 
 
8  
Vertiflex® OBLIGATIONS 
8.1 
Investigator(s) Training 
Vertiflex® will provide appropriate training to each Investigator that includes didactic and hands-
on elements, e.g., cadaver lab, sawbones model.  Training will including surgical procedures in 
accordance with the Superion® Surgical Technique Manual, selection of appropriate implant sizes, 
instrumentation for implantation, indications for use of the device, contraindications, and 
management of complications.  Vertiflex® will also provide appropriate training to the operating 
room staff at each investigational site, where applicable. 
8.2 
Vertiflex® Registry Termination 
Vertiflex® may close enrollment or terminate the registry at any site, at any time, for non-
compliance to GCP guidelines or this protocol, or for other valid reason. 
8.3 
Registry Monitoring 
Vertiflex® may elect to monitor the registry during its active phase.  Any such monitoring visits 
will be scheduled by prior arrangement with the Investigator, and monitoring will be carried out 
in compliance with GCP guidelines. 
9 
LIST OF APPENDICES 
 
Appendix A:  Visit Schedule 
 
Appendix B:  Case Report Forms