FAQ Brochure - Gore Medical

FREQUENTLY ASKED QUESTIONS
P E R F O R M A N C E
t h r o u g h c o l l a b o r a t i o n

Table of Contents
GORE ® VIABAHN ® Endoprosthesis with
PROPATEN Bioactive Surface FAQs
What is the GORE ® VIABAHN ® Endoprosthesis with
PROPATEN Bioactive Surface? ......................................................2
What is unique about the heparin technology of the GORE ®
VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface? ........3
How does end-point covalent bonding of heparin differ
from conventional covalent bonding of heparin and ionic
bonding of heparin? ....................................................................4
How long does the heparin last? ..................................................4
What kind of heparin is used for the GORE ® VIABAHN ®
Endoprosthesis with PROPATEN Bioactive Surface? ......................5
Does the PROPATEN Bioactive Surface change the
microstructure of the ePTFE? ........................................................5
How many International Units (IU) of heparin are on
the surface of a GORE ® VIABAHN ® Endoprosthesis with
PROPATEN Bioactive Surface? ......................................................5
Does heparin elute from the surface? ...........................................5
Can I change my anticoagulation procedure while
using the GORE ® VIABAHN ® Endoprosthesis with
PROPATEN Bioactive Surface? ......................................................5
Can systemic heparin be reduced while using the GORE ®
VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface? ......5
Can Protamine be used? ..............................................................5
Can I change my patients’ post-operative antiplatelet regime? ......5
What is HIT? ................................................................................6
How does the presence of PROPATEN Bioactive Surface
affect the risk of HIT? ...................................................................6
What treatment protocol should I follow if a GORE ®
VIABAHN ® Endoprosthesis with PROPATEN Bioactive
Surface patient develops HIT? ......................................................6
Can the GORE ® VIABAHN ® Endoprosthesis with
PROPATEN Bioactive Surface be revised if it occludes? ..................7
How is the device sterilized and can I resterilize it?.......................7
Does the PROPATEN Bioactive Surface require
any special storage requirements? ..............................................7
Will post-deployment dilation of the endoprosthesis
damage the PROPATEN Bioactive Surface? ...................................7
What is the benefit of the PROPATEN Bioactive Surface? ...............7
Who is Carmeda AB? ...................................................................7
What medical devices use Carmeda BioActive Surface
(CBAS ® ) technology? ...................................................................8
How does the PROPATEN Bioactive Surface on the
GORE ® VIABAHN ® Endoprosthesis compare to the heparin
coating on the Bx VELOCITY ® Coronary Stent with HEPACOAT ® ? .....8
What is the indication for the GORE ® VIABAHN ®
Endoprosthesis with PROPATEN Bioactive Surface? ......................8
GORE ® VIABAHN ® Endoprosthesis FAQs
What is ePTFE? ............................................................................9
What clinical data exists for the
GORE ® VIABAHN ® Endoprosthesis in the SFA? ..............................9
Are there any clinical considerations when using
the GORE ® VIABAHN ® Endoprosthesis? ........................................9
What about in-stent restenosis? ................................................10
Is there any Level 1 clinical data for the
GORE ® VIABAHN ® Endoprosthesis? ............................................10
What about SFA stent fractures with the
GORE ® VIABAHN ® Endoprosthesis? ............................................10
What are the potential failure modes of the
GORE ® VIABAHN ® Endoprosthesis? ............................................11
What is the effect of the contoured proximal edge?.....................11
What is the rate of thrombosis for the
GORE ® VIABAHN ® Endoprosthesis? ............................................12
References ................................................................................13
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GORE ® VIABAHN ® Endoprosthesis with
PROPATEN Bioactive Surface FAQs
What is the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface is a flexible, self-expanding
endoluminal endoprosthesis consisting of an expanded polytetrafluoroethylene (ePTFE) lining with
an external nitinol support extending along its entire length. The surface of the endoprosthesis is
modified with covalently bonded bioactive heparin (PROPATEN Bioactive Surface).
• Ultra thin wall ePTFE lining
• Unique, durable bonding film
• Polished nitinol stent
• Heparin-bonded surface
• Contoured proximal edge
• Lengths: 2.5, 5, 10, 15, 25 cm
• Diameters: 5 – 13 mm

What is unique about the heparin technology of the
GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
• Proprietary end-point covalent bonding
• Sustained bioactivity 1
• Minimal heparin elution within the first 24 hours
The heparin molecules are covalently bonded to the surface through a proprietary end-point
attachment mechanism (Carmeda ® BioActive Surface (CBAS ® )) which serves to anchor heparin
molecules to the surface while still maintaining heparin’s intrinsic bioactive properties.
The result: a surface that is intended to maintain thromboresistance over time.
AT-T
AT-T
T
A covalent end-point linkage mechanism
allows bonding of the heparin molecules to the
endoprosthesis while retaining heparin’s anticoagulant
activity. The active site of a heparin molecule enables
antithrombin (AT) to bind, thus increasing the efficiency
of AT to subsequently bind to thrombin (T).
When thrombin (T) binds to antithrombin (AT) an AT-
T complex is formed. The neutralized thrombin loses
its ability to catalyze the conversion of fibrinogen to
fibrin. Consequently, fibrin (a major component of
thrombus) deposition on the endoprosthesis surface
is suppressed.
The neutral AT-T complex detaches from the heparin
molecule thus leaving the heparin bioactive site available
to again bind antithrombin. The resulting catalytic cycle
enables the thromboresistant process to perpetuate.
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How does end-point covalent bonding of heparin differ from
conventional covalent bonding of heparin and ionic bonding of heparin?
Conventional Covalent Bonding
In conventional, multiple point, covalent bonding, the anticoagulant properties of heparin are lost
due to the fact that the heparin active site is not available to antithrombin.
Ionic Bonding
In ionic bonding, the attractive force of negatively charged heparin and positively charged coating
can be easily broken, thus allowing heparin to be released from the surface over time. Sustained
thromboresistance cannot be achieved.
End-point Covalent Bonding
How long does the heparin last?
The heparin molecule (yellow) is bonded (white) at
multiple points to the device surface (orange).
The heparin active site (red) is unavailable to
antithrombin. Without bioactivity, the anticoagulant
properties of heparin are lost.
The negatively (-) charged heparin molecule (yellow) is
attracted to a positively (+) charged coating (orange) on the
device surface. This attractive force can be broken, allowing
heparin to release from the surface over time. Sustained
thromboresistance cannot be achieved.
End-point covalent bonding is a unique concept that allows the anticoagulant
properties of heparin to be harnessed directly on the endoprosthesis surface. The
end of each heparin molecule is bonded to the surface, allowing the heparin active
site to freely interact with anti-thrombin. Consequently, heparin is retained on the
endoprosthesis surface in a bioactive form. This results in a endoprosthesis surface
with sustained thromboresistance.
In order to resist thrombus build-up, it is essential that heparin is present on the surface
and retains its bioactive function. While there is no specific data for the GORE ® VIABAHN ®
Endoprosthesis with PROPATEN Bioactive Surface, data from other devices modified using the
same proprietary end-point heparin-bonding technology gives some insight into the longevity
of the heparin activity. GORE ® PROPATEN ® Vascular Graft explants from an in vivo canine model
demonstrated the continued presence of heparin on the graft surface and showed sustained
heparin bioactivity over a period of 12 weeks 1 . Riesenfeld has reported substantial bioactivity
on Berlin Heart ventricular assist devices (same as the CBAS ® technology used on the GORE ®
VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface) removed from patients after 855
days 2 . Finally, a GORE ® PROPATEN ® Vascular Graft explanted after occlusion of outflow vessels after
1,111 days continued to exhibit heparin activity within the original manufacturing specifications.

What kind of heparin is used for the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
Reduced molecular weight heparin derived from USP heparin of porcine origin is used in the
construction of the PROPPATEN Bioactive Surface.
Does the PROPATEN Bioactive Surface change the microstructure of the ePTFE?
The thickness of a CBAS ® coating is approximately 200 nanometers (nm) 14 . This is not sufficient to
change the microstructure of the ePTFE.
How many International Units (IU) of heparin are on the surface of a
GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
Heparin activity in solution is typically measured in terms of International Units (IU). Surface
bound heparin, on the other hand, is normally measured in terms of picomoles of ATIII activity.
A reasonable estimate of the number of IUs on the endoprosthesis surface can be obtained via
theoretical calculations. Based on the mass of heparin on the surface, theoretical calculations yield
an estimate of < 400 IU per endoprosthesis (8 mm x 15 cm). This is very small compared to the
typical intraoperative heparin dose of ~5,000 IU.
Does heparin elute from the surface?
The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface binds heparin to the
endoprosthesis surface via a stable covalent linkage. In vitro experiments performed on the
GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface have shown that less than 30
IU of heparin are released into solution during the first 24 hours after initiation of flow (data on
file). Thereafter, there is minimal release of heparin and no systemic effect.
Can I change my anticoagulation procedure while using the
GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
The physician should consider the need for intraoperative and / or postoperative anticoagulation
therapy based on the pharmacological requirements and medical history of the patient.
The presence of heparin on the endoprosthesis is not intended to serve as an alternative to
the surgeon’s chosen intraoperative or postoperative anticoagulation regimens.
Can systemic heparin be reduced while using the
GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
The presence of heparin on the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface
is not intended to serve as an alternative to intraoperative or postoperative anticoagulation.
The anticoagulant effect of the heparin on the endoprosthesis is limited to the device surface
and does not have a systemic anticoagulant effect.
Can protamine be used?
There is no long-term effect by protamine on the bioactivity of the PROPATEN Bioactive Surface.
Although protamine reverses the anticoagulant activity of heparin, its effect is transitory.
Protamine can only remain bound to heparin when it is present in sustained excess quantities.
Since protamine is rapidly removed from the circulation, any effect is short-lived, as protamine
desorbs from the endoprosthesis surface into the blood stream.
Can I change my patients’ post-operative antiplatelet regime?
The presence of heparin on the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface
is not intended to serve as an alternative to the physician’s chosen postoperative antiplatelet
regimens. The post-operative antiplatelet regimen is left at the discretion of the physician.
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What is HIT?
Heparin-Induced Thrombocytopenia (HIT) occurs in a relatively small subset of the patient
population and is defined as a decrease in platelet count during or shortly following exposure to
heparin3 . There are two distinct types of HIT, each with very different clinical ramifications.
HIT type I is characterized by a mild and transient asymptomatic thrombocytopenia that develops
within the first few days of starting heparin treatment and disappears quickly following heparin
cessation4 . This type of HIT is benign and is not associated with an increased risk of thrombosis.
HIT type II is characterized by rapid or delayed-onset thrombocytopenia that is associated with
a risk of thrombosis5 . In the following discussion, HIT type II will be referred to simply as HIT.
The mechanism underlying HIT is an immune response as antibodies are formed against a
heparin-platelet factor 4 (PF4) complex. The antibody-heparin-PF4 immunocomplex binds to
platelets, inducing platelet activation and aggregation. Thrombocytopenia results from the clearance
of activated platelets and antibody-coated platelets by the reticulo-endothelial system5, 6 . Typically,
patients receiving heparin for the first time experience the onset of thrombocytopenia 5 – 8 days after
the administration of heparin; however, the onset can be rapid (< 1 day) in patients with antibodies
from a previous exposure7, 8 or delayed up to 3 weeks after heparin therapy has stopped9-12 .
How does the presence of PROPATEN Bioactive Surface affect the risk of HIT?
The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface is contraindicated for
patients with known hypersensitivity to heparin, including those patients who have had a previous
incidence of HIT type II.
For patients who do not have a known hypersensitivity to heparin, the theoretical potential of any
heparin bonded device to cause platelet aggregation and thrombocytopenia does exist. However,
since interventions in the vascular system almost invariably involve administration of systemic
heparin, it becomes difficult, if not impossible, to judge whether or not the heparin bonded device
contributed to the development of HIT.
The body of clinical evidence to date for the PROPATEN Bioactive Surface does not show any
relationship between the implantation of this product and HIT. In a study by Heyligers, et al13 ,
HIT-inducing antibodies were not detected in any of the patients that received the GORE ®
PROPATEN ® Vascular Graft even after six weeks of implantation.
The incidence of reported cases of HIT after implantation of the GORE ® PROPATEN ® Vascular Graft
is less than 0.1% worldwide. It is not known if the graft contributed to the development of HIT in
these patients.
The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface does not elute heparin
into the bloodstream and hence has no systemic effect. Based on the mass of heparin on the
surface of the endoprosthesis, theoretical calculations yield an estimate of < 400 IU of heparin per
endoprosthesis (8 mm x 15 cm). This is very small compared to the typical intraoperative heparin
dose of ~5,000 IU.
What treatment protocol should I follow if a GORE ® VIABAHN ® Endoprosthesis
with PROPATEN Bioactive Surface patient develops HIT?
The incidence of HIT type II is extremely low in vascular bypass patients receiving heparin over a
period of several days. If HIT type II is diagnosed, established procedures for the treatment of this
condition, including immediate cessation of systemic heparin administration, should be followed.
If symptoms persist, or the health of the patient appears compromised, alternative pharmaceutical
or surgical procedures, including surgical bypass and / or removal of the endoprosthesis, may be
considered at the discretion of the attending physician.
The incidence of reported cases of HIT after the implantation of the GORE ® PROPATEN ® Vascular
Graft is less than 0.1%. It is not known if the graft contributed to the development of HIT.

Can the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface be revised if it occludes?
The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface can be revised like the
non-heparin bonded GORE ® VIABAHN ® Endoprosthesis. Bioactivity of the PROPATEN Bioactive
Surface after a revision procedure has not been established.
How is the device sterilized and can I resterilize it?
The device is sterilized using Ethylene Oxide. The GORE ® VIABAHN ® Endoprosthesis with PROPATEN
Bioactive Surface should not be resterilized.
Does the PROPATEN Bioactive Surface require any special storage requirements?
The PROPATEN Bioactive Surface does have susceptibility to humidity. However, the foil pouch is
both a moisture and a sterile barrier, and sufficiently protects the device from humidity. DO NOT
use or store the device if the foil pouch has been compromised. The package should be stored in a
cool dry place (the shelf of a cath lab is fine). The product does have an expiration date and should
be used before the labeled “use by” (expiration) date marked on the box.
Will post-deployment dilation of the endoprosthesis damage the PROPATEN Bioactive Surface?
The PROPATEN Bioactive Surface is designed to withstand balloon touch up. In vitro tests show
that balloon touch up with the appropriately sized balloon will not affect the activity of the heparin
surface (data on file).
What is the benefit of the PROPATEN Bioactive Surface?
While there is no direct clinical evidence to indicate that the PROPATEN Bioactive Surface has
an affect on the effectiveness of the GORE ® VIABAHN ® Endoprosthesis, the Carmeda ® BioActive
Surface (CBAS ® ), upon which PROPATEN Bioactive Surface is based, has a long clinical history.
Some of the reported features and benefits of the CBAS ® bioactive coating technology include:
long-term bioactivity, non-leaching, reduced thrombus formation / platelet adhesion, decreased
inflammatory response, and antimicrobial protection 14 .
Who is Carmeda AB?
Carmeda AB, a Swedish company, invented the end-point heparin bonding technology used on the
GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface and other medical devices.
This end-point heparin bonding technology is termed the Carmeda ® BioActive Surface (CBAS ® ).
Carmeda AB is a world leader in heparin technology with a long history of pioneering research in
this field since the company was founded in 1984. In October, 2005, Carmeda AB became a wholly
owned subsidiary of W. L. Gore & Associates, Inc.
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What medical devices use Carmeda ® BioActive Surface (CBAS ® ) technology?
Carmeda AB has developed several successful partnerships with companies that manufacture
medical devices such as coronary stents, oxygenator circuits, ventricular assist devices, blood
gas sensors and central venous catheters. Over 200 scientific papers including numerous clinical
studies have demonstrated the safety, efficacy and superiority of the CBAS ® technology.
The reported features and benefits of the CBAS ® bioactive coating technology include: long-term
bioactivity, non-leaching, reduced thrombus formation / platelet adhesion, decreased inflammatory
response, and antimicrobial protection14 .
The GORE ® PROPATEN ® Vascular Graft utilizes the same process used to create the PROPATEN
Bioactive Surface. Since its 2002 market introduction in the European Union and in several
countries worldwide, the GORE ® PROPATEN ® Vascular Graft has been used in several peripheral
applications including lower extremity revascularization. Several prospective and retrospective
studies undertaken thus far support the safety and efficacy of the GORE ® PROPATEN ® Vascular
Graft15 .
How does the PROPATEN Bioactive Surface on the GORE ® VIABAHN ® Endoprosthesis
compare to the heparin coating on the Bx VELOCITY ® Coronary Stent with HEPACOAT ® ?
Although these devices have different indications and therefore cannot be directly compared,
the heparin surface on both devices utilizes the same CBAS ® technology to create a permanent,
bioactive heparin surface. However, there are two distinct differences between a heparin-bonded
stent and a heparin-bonded stent-graft: the amount of lesion coverage provided by the coated
device and the length of time that the surface is exposed to the blood stream.
Lesion coverage Placement of a coated bare stent leaves a substantial part of the diseased vessel
lumen exposed. The effect of the surface-bound heparin is limited to the stent struts and not the
entire stented region. However, the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive
Surface completely lines the diseased vessel. The surface-bound heparin is present throughout the
treated region.
Exposure time Bare coronary stents rapidly re-endothelialize following implantation16 . Thus, within
weeks after implantation, any heparin bound to the stent struts would be masked by neointimal
and endothelial cells, rendering it irrelevant. In contrast, the ePTFE lining of the GORE ® VIABAHN ®
Endoprosthesis with PROPATEN Bioactive Surface inhibits cellular infiltration, thus leaving the
heparin exposed and bioactive. Studies of an ePTFE vascular graft with the same heparin coating
have shown sustained heparin bioactivity out to at least 3 months1 . Riesenfeld has reported
substantial bioactivity on a CBAS ® -coated Berlin Heart ventricular assist devices (same as the
CBAS ® technology used on the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface)
removed from patients after 855 days2 . Finally, a GORE ® PROPATEN ® Vascular Graft explanted
after occlusion of outflow vessels after 1,111 days continued to exhibit heparin activity within the
original manufacturing specifications. Theoretically, as long as the endoprosthesis is free from
neointimal or pseudo intimal overgrowth, the heparin is available and active.
What is the indication for the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface?
The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface is a flexible, selfexpanding
endoluminal prosthesis for endovascular grafting of peripheral arteries.

GORE ® VIABAHN ® Endoprosthesis FAQs
What is ePTFE?
ePTFE is an acronym for expanded polytetrafluoroethylene. PTFE is an extremely inert,
biocompatible biomaterial composed solely of carbon and fluorine. When PTFE is expanded at a
high temperature and rate, ePTFE is formed with a node-fibril microstructure. This discovery was
made by Bob Gore in 1969. Since the mid-1970’s, ePTFE vascular grafts have been the synthetic
material of choice by vascular surgeons performing peripheral bypass operations or creating
dialysis access grafts.
What clinical data exists for the GORE ® VIABAHN ® Endoprosthesis in the SFA?
The GORE ® VIABAHN ® Endoprosthesis has an impressive amount of published clinical data. There have
been 17 independent studies reporting primary patency for the endoprosthesis with greater than 30
patients. For the published 1103 limbs, with an average lesion length of 16 cm, the weighted average
one year primary patency is 77%.
Reported Patencies of GORE ® VIABAHN ® Endoprosthesis /
GORE ® HEMOBAHN ® Endoprosthesis (5 – 8mm) treating the SFA in Studies of at least 30 limbs
Author Year Journal Publication / Presentation
No. of
Limbs
Lesion
Length
(cm)
%
Occlusions
Primary Patency
(years / %)
1 2 3 4
Lammer 2000 Radiology, 217:95-104 80 13.8 NR 79
Jahnke 2003 J Vasc Interv Radiol, 14:41-51 52 8.5 83 78 74 62
Bleyn 2004 Edizioni Minerva Medica, 14:87-91 67 14.3 100 82 73 68 54
Panetta 2005 Endovasc Today, August 41 30.4 90 86 77
Chopra 2006 AIM Symposium, November 13 – 16 70 20 71 93 87 72
Coats 2006 Endovasc Today, September 83 NR 47 89
Fischer 2006 J Endovasc Ther, 13:281-290 59 10.7 87 67 58 57 52
Zander 2006 SIR Meeting, April 3 31 16.6 NR 86 78 78 78
Saxon 2007 J Vasc Interv Radiol, 18:1341-1350 87 14.2 42 76 65 60 55
Alimi 2008 Eur J Vasc Endovasc Surg, 35:346-352 102 11.7 NR 74 71 71
Djelmami-Hani 2008 SCAI Meeting, March 29 – April 1 132 21 39 80
Saxon 2008 J Vasc Interv Radiol, 18:823-832 97 7 21 65
VIBRANT 2009 VIVA, September 19 – 22 72 19 60 53
Kougias 2009 Am J Surgery, 198:645-649 31 23 100 75
Farraj 2009 J Invasive Cardiol, 21:278-281 32 15.4 100 80
Rebellino 2009 Cath Cardiovasc Interv, 73:701-705 32 NR NR 82 75 75 75
McQuade 2010 J Vasc Surg, 52:584-591 50 25.6 NR 72 63 63 59
Average / Total
NR = Not Reported
1103 16.1 62 77 72 67 59
Are there any clinical considerations when using the GORE ® VIABAHN ® Endoprosthesis?
Some key clinical learnings that have emerged include:
• Avoid non-compliant lesions
• Ensure adequate inflow and outflow (i.e., at least one vessel run-off)
• Correct sizing is key
• Land device at least 1 cm into healthy vessel proximally and distally to the lesion
• Every region pre-treated with PTA needs to be covered by the device
• During post dilatation, only balloon inside the region covered by the device
• Consider an antiplatelet regimen post-procedure
• Do not use the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface in patients
with known hypersensitivity to heparin, including those patients who have had a previous
incidence of Heparin-Induced Thrombocytopenia (HIT) type II.
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What about in-stent restenosis?
The ePTFE lining of the GORE ® VIABAHN ® Endoprosthesis limits in-stent restenosis, and because of
this, patency is independent of lesion length. For the studies presented in the table above, a plot
of the 1 year primary patency versus lesion length (17 studies, 1103 limbs) shows that patency is
indeed independent of lesion length.
1 Year Primary Patency
100%
80%
60%
40%
20%
0%
0 5 10
15 20 25 30 35
Average Lesion Length Treated (cm)
Is there any Level 1 clinical data for the GORE ® VIABAHN ® Endoprosthesis?
There are 2 published studies that present Level 1 clinical data for the GORE ® VIABAHN ®
Endoprosthesis.
From 1998 – 1999, the GORE ® VIABAHN ® Endoprosthesis was evaluated in a randomized,
multicenter trial, and published in the Journal of Vascular and Interventional Radiology in 200828 .
The purpose of the study was to compare the safety and effectiveness of the GORE ® VIABAHN ®
Endoprosthesis to percutaneous transluminal angioplasty (PTA) in patients with chronic lower
limb ischemia or chronic lifestyle altering claudication due to superficial femoral artery (SFA)
atherosclerotic disease. A total of 241 patients or 244 cases (limbs) were treated in the study. Each
site was permitted up to two training cases. A total of 47 training cases were performed; 197 cases
were randomized with 100 assigned to PTA and 97 to the GORE ® VIABAHN ® Device. The GORE ®
VIABAHN ® Endoprosthesis showed 25% better 12-month redefined primary patency than PTA: 65%
vs. 40%. Patency in this study was defined as target vessel, not target lesion, patency (PSVR < 2.0
via DUS at 12 months).
A second study was published in the Journal of Vascular Surgery by McQuade et al33 in 2010. In this
randomized, single center study, the GORE ® VIABAHN ® Endoprosthesis was compared to prosthetic
fem-pop surgical bypass in treating superficial femoral artery occlusive disease. Fifty limbs were
enrolled into each study arm with ankle-brachial indices and color duplex flow sonography imaging
performed at 3, 6, 9, 12, 18, 24, 36, and 48 months. The primary patency rate for the stent graft
group at 12, 24, 36, and 48 months was 72%, 63%, 63%, and 59%, respectively, while the primary
patency for the surgical bypass group was 76%, 63%, 63%, and 58%, respectively,The average
treatment length was 25.6 cm for the GORE ® VIABAHN ® Endoprosthesis.
What about SFA stent fractures with the GORE ® VIABAHN ® Endoprosthesis?
The device has excellent flexibility and is well-suited for the SFA. There is a very low incidence
(

What are the potential failure modes of the GORE ® VIABAHN ® Endoprosthesis?
Although primary patency at 1 year is excellent (77%), the literature does report some failure
modes and how they can be mitigated. Examples include:
Failure Mode Mitigators
Edge Restenosis Don’t balloon outside the device; properly oversize the device (5 – 20%)
Progression of Disease Cover all of the diseased vessel; distal and proximal landing zones should be in healthy vessel
Thrombosis Complete post-dilatation; appropriate antiplatelet therapy; regular patient follow-up
What is the effect of the contoured proximal edge?
The contoured proximal edge is a manufacturing change that was implemented to improve
repeatability in processing, and leads to improved apposition of the device to the vessel wall. The
conformable fit of the stent-graft may improve flow dynamics at the proximal edge of the stent.
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What is the rate of thrombosis for the GORE ® VIABAHN ® Endoprosthesis?
There are two thrombosis events to consider: acute and late.
Acute Thrombosis (< 30 days of procedure). As reported in the literature, the GORE ® VIABAHN ®
Endoprosthesis has an acute thrombosis rate of 2 – 5% 17, 19, 34, 35 . This is similar to the 3 – 4% acute
thrombosis rates of bare nitinol stents36, 37 . Thus, this acute thrombosis rate is likely procedure related
rather than related to any inherent thrombogenicity of the device.
Late Thrombosis (> 30 days of procedure). If a GORE ® VIABAHN ® Endoprosthesis fails, it may present
itself as a thrombosed endoprosthesis. Often this is secondary to another failure mode (edge stenosis
or disease progression) and a result of low blood flow through the endoprosthesis. The occluded
endoprosthesis can be revised, and the adjacent disease treated using an additional endoprosthesis.
The long-term patency of the GORE ® VIABAHN ® Endoprosthesis at 5 years in a selected patient
population was recently reported to be 62% (primary patency) and 90% (secondary patency) by
Fischer, et al 23 . This secondary patency demonstrates the durability and patency of the endoprosthesis
after revision.
Occluded
GORE ® VIABAHN ® Device
(arrow indicates
proximal edge of device)
Images courtesy of Richard Saxon
After lysis,
edge stenosis apparent PTA of the edge stenosis

References
1. Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX ® Vascular Graft performance by Carmeda ® bioactive surface heparin
immobilization. European Journal of Vascular and Endovascular Surgery 2003;25(5):432-437.
2. Riesenfeld J, Ries D, Hetzer R. Analysis of the heparin coating of an EXCOR ® Ventricular Assist Device after 855 days in a patient. Abstract presented at the 32nd Society
for Biomaterials Annual Meeting. April 18-21, 2007. Chicago, IL. Abstract 180.
3. Warkentin TE. An overview of the heparin-induced thrombocytopenia syndrome. Seminars in Thrombosis & Hemostasis 2004;30(3):273-283.
4. Franchini M. Heparin-induced thrombocytopenia: an update. Thrombosis Journal 2005;3(1):14-18.
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