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S H O R T W I R E
B I L I A R Y E N D O P R O S T H E S I S
Maximize Control.
Minimize Migration.
New
SHORT
WIRE
Delivery System
Improved treatment of biliary strictures
The self-expanding, fully-covered metal stent is intended for palliation of malignant strictures in the
biliary tree. The GORE®
VIABIL®
Short Wire Biliary Endoprosthesis is the only fully covered metal stent
with anti-migration technology proven to minimize the risk of reintervention. Additionally, it offers
substantiated evidence in studies that demonstrate sustained long-term patency.
The precision you expect.
Non-foreshortening*
stent design and short wire delivery system provide optimal deployment positioning.
The outcomes you demand.
Designed to reduce the risk of migration and premature obstruction, while sustaining long-term patency.
The assurance you can count on.
With a 0.2% average reported migration rate1
, GORE®
VIABIL®
Short Wire Biliary Endoprosthesis is backed
by a device replacement program if a migration occurs.2
We’re so confident, we now offer an
ANTI-MIGRATION ASSURANCE PROGRAM
Replacement if a device migrates within one full year post implantation**
*If deployed as instructed, the endoprosthesis will not appreciably foreshorten.
**See back for the details of the assurance program.
Demonstrated low migrations
	 Fully covered anchoring fins
Securely holds the device within the duct to minimize
the risk of migration, with a reported 0–1.4%
migration rate range outperforming BOSTON
SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent
migration rates ranging up to 0–13%.1
	
Optimal Conformability
	 Nitinol Wire based stent design
Optimal balance of Radial and Axial force provides
the right fit and flexibility to help prevent migration
and sludge formation.3,4
	
Prevents tissue ingrowth and
promotes conformability
	 Durable, non-porous FEP/ePTFE liner
Prevents tissue ingrowth and promotes conformability.
Proven highest patency helps provide a high standard
of palliative care for your patients.5,6
	
1
1
3
2 BOSTON SCIENTIFIC WALLFLEX
Biliary RX Fully Covered Stent
GORE®
VIABIL®
Short Wire
Biliary Endoprosthesis
Precise delivery
New short wire delivery system
Combined short wire delivery system and stent
flexibility provides accurate delivery with optimal
positioning and deployment.
Non-foreshortening design
for precision you can count on.
During delivery:
• Unlike other stents, eliminates repositioning
associated with typical push/pull delivery
• Will not appreciably change in length
2
3
Anti-migration design
Unique anti-migration design features atraumatic anchoring fins to help minimize the risk of migration
and mitigate clinical challenges.
MIGRATION RATE COMPARISON1
Based on 23 papers published from 2002 to 2015.
Unique combination for the treatment of biliary obstruction
0.0% Bezzi M et al.
0.0% Fanelli F et al.
0.0% Hatzidakis A et al.
0.0% Krokidis M et al.
0.0% Irurzun J et al.
0.0% Krokidis M et al.
0.0% Marzio A et al.
0.0% Scheer F et al.
0.0% Schoder M et al.
0.0% Van Steenbergen W
0.0% Zurstrassen CE et al.
1.4% Bakhru M et al.
0–1.4%
(0.2%weightedaverage)
Siddiqui et al. 5.0%
Lee et al. 7.0%
Chedid et al. 8.8%
Ryozawa et al. 13.0%
Kahaleh et al. 1.5%
Nakai et al. 0.0%
Kitano et al. 0.0%
Korenblit et al. 3.9%
Sampaziotis et al. 4.7%
Petersen et al. 1.7%
Ogawa et al. 2.8%
BOSTON SCIENTIFIC WALLFLEX
Biliary RX Fully Covered Stent
0–13%
(4.6%weightedaverage)
GORE®
VIABIL®
Biliary Endoprosthesis
Average reported
migration rate is ≈ 0.2%.1
We’re so confident, we now offer an
ANTI-MIGRATION
ASSURANCE PROGRAM
Replacement if a device migrates
within one full year post implantation
Compared to the BOSTON SCIENTIFIC
WALLFLEX Biliary RX Fully Covered
Stent, the GORE®
VIABIL®
Biliary
Endoprosthesis has low Af and
moderate Rf, the preferred
combination for reducing migration
and achieving higher patency.4
TRAIGHTENING AXIAL FORCE
Higher primary patency
Clinical performance demonstrates GORE®
VIABIL®
Biliary Endoprosthesis maintains higher primary patency
than the leading competitor at 3, 6, and 12-months.5,6
Improved long-term patency can mean an improved
quality of life for patients.
Preferred combination
Preferred balance of Axial and Radial forces*
conform to duct anatomy
According to studies by Isayama et al., 2012, stent migration and sludge formation is related to the device
conformability in the bile duct, which is influenced by the device’s axial force (Af).3
A balance of low
axial force and moderate radial force (Rf) is preferred for optimal performance.4
GORE®
VIABIL®
Biliary Endoprosthesis is the preferred combination of low Af
and moderate Rf to minimize risk of migration, conforming naturally to the
bile duct anatomy.4
SEMS with high Af do not conform well in the curved bile duct, increasing the
risk of stent migration. Additionally, the duct tends to kink at the proximal edge
of the stent, causing sludge formation or cholangitis.3
STRAIGHTENING AXIAL FORCE
High axial force
Low axial force
RadialForce(N)
14
12
10
8
6
4
2
0
Axial Force (mN)
0 20 40 60 80 100 120
GORE®
VIABIL®
Biliary Device (ø10mn)
GORE®
VIABIL®
Biliary Device (ø8mn)
BOSTON SCIENTIFIC WALLFLEX Biliary RX Stent (ø10mn)
BOSTON SCIENTIFIC WALLFLEX Biliary RX Stent (ø8mn)
100%
90%
80%
70%
60%
50%
12 months6 months3 months
100%
98.3%
96.2%
84.3% 76.5%
63.5%BOSTON SCIENTIFIC WALLFLEX
Biliary RX Fully Covered Stent
GORE®
VIABIL®
Biliary
Endoprosthesis
* Axial force is the recovery force that leads to straightening after being bent, while
Radial force maintains and expands the luminal patency at the stricture once deployed.
Economic impact of migration
Assume your hospital does 100 endoscopic retrograde cholangiopancreatography (ERCP) with stent
placements per year, with the average patient survival for malignant strictures being six months.
GORE®
VIABIL®
Short Wire
Biliary Endoprosthesis
BOSTON SCIENTIFIC WALLFLEX
Biliary RX Fully Covered Stent
Migration Rate (average)1
0.2% 4.6%
Estimated number of reinterventions
to manage migrations (per year)
1 5
Estimated patency at six months5,6
96.2% 84.3%
Estimated number of reinterventions
to manage loss of patency (per year)
4 16
Total number of reinterventions expected per year 5 21
Estimated additional cost per year due to
reinterventions (includes ERCP + Stent cost)*
$32,205 $151,221
*Average cost of inpatient ERCP is $4649. Source: National Healthcare payer database, 2015
Gore has used reasonable efforts to ensure the completeness and accuracy of the information contained herein as of the date this document was prepared. Gore is not
liable for any claims or actions attributable to the use of this, nor for any errors or omissions involved in the use of the information, or the results. Payment policies are
variable depending on the payer, geographic location and provider specific contracts. The models provided here are for illustrative purposes only and are not intended
to be indicative of payment from any payer.
Potential economic impact
If GORE®
VIABIL®
Short Wire Biliary
Endoprosthesis was used to treat
100 patients with unresectable
malignant biliary strictures, your
institution is estimated to annually:
ELIMINATE 16 REINTERVENTIONS
due to migrations and reduced patency, and
SAVE $116,716
versus using BOSTON SCIENTIFIC
WALLFLEX Biliary RX Fully Covered Stent.
Sizing and specifications
Endoscopic
GORE®
VIABIL®
Short Wire Biliary
Endoprosthesis
Catalogue Number
GORE®
VIABIL®
Biliary
Endoprosthesis
Catalogue Number
Endoprosthesis
Diameter (mm) ×
Length (cm)
Working Length
of Delivery
Catheter (cm)
Drainage Holes
Located At the
Hilar Region
Transmural
Drainage Holes
Length (cm)
VSWVN0804 VN0804200 8 x 4 200 No holes —
VSWVN0806 VN0806200 8 x 6 200 No holes —
VSWVN0808 VN0808200 8 x 8 200 No holes —
VSWVN0810 VN0810200 8 x 10 200 No holes —
VSWVN1004 VN1004200 10 x 4 200 No holes —
VSWVN1006 VN1006200 10 x 6 200 No holes —
VSWVN1008 VN1008200 10 x 8 200 No holes —
VSWVN1010 VN1010200 10 x 10 200 No holes —
VSWVH0806 VH0806200 8 x 6 200 Holes 2
VSWVH0808 VH0808200 8 x 8 200 Holes 2
VSWVH0810 VH0810200 8 x 10 200 Holes 2
VSWVH1006 VH1006200 10 x 6 200 Holes 2
VSWVH1008 VH1008200 10 x 8 200 Holes 2
VSWVH1010 VH1010200 10 x 10 200 Holes 2
Sizing, availability, and pricing varies by country.
Please check with your representative for availability.
W. L. Gore  Associates, Inc.
Flagstaff, AZ 86004
+65.67332882 (Asia Pacific)	 800.437.8181 (United States)
00800.6334.4673 (Europe)	 928.779.2771 (United States)
goremedical.com
Products listed may not be available in all markets.
WALLFLEX is a trademark of Boston Scientific Corporation
GORE®
, VIABIL®
, and designs are trademarks of W. L. Gore  Associates.
© 2017 W. L. Gore  Associates, Inc. AW0305-EN1 JUNE 2017
REFERENCES
1.	W. L. Gore  Associates, Inc. Migration Summary for GORE®
VIABIL®
Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent.
Flagstaff, AZ: W. L. Gore  Associates, Inc; 2017. [Literature Summary]. AW0010-EN3.
2. W. L. Gore  Associates, Inc. Reduce the risk of reintervention. GORE®
VIABIL®
Biliary Endoprosthesis Assurance Brochure. Flagstaff, AZ: W. L. Gore  Associates, Inc;
2017. [Flyer]. AW0165-EN1.
3.	Isayama H, Mukai T, Itoi T, et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal
malignant biliary obstruction: the WATCH study. Gastrointestinal Endoscopy 2012;76(1):84-92.
4.	Isayama H, Nakai Y, Toyokawa Y, et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointestinal Endoscopy 2009;70(1):37-44.
5. Kitano M, Yamashita Y, Tanaka K, et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications
compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22.
6.	Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil
stent versus uncovered Wallstents. Cardiovascular  Interventional Radiology 2010;33(1):97-106.
ANTI-MIGRATION ASSURANCE PROGRAM DETAILS
Gore will provide a replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation.
The replacement device is only available if GORE®
VIABIL®
Biliary Endoprosthesis is implanted in accordance with the device Instructions for Use
(The GORE®
VIABIL®
Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree) and the other terms of the program are
satisfied. Replacement devices provided under this program are not eligible for the program. Claims under the program are limited to the replacement
device. Upon receipt of the appropriate documentation, a replacement device will be provided pursuant to the program accompanied by a no-charge
invoice shipped directly to the hospital. The hospital is responsible for reporting the no-charge replacement stent as a discount on the hospital’s cost
report. All reports of migration will be documented appropriately within the Gore internal product surveillance process and additional information
may be requested. Migrations are a known risk of any biliary endoprosthesis. The provision of a replacement device as part of the program does not
constitute an admission that there was a device malfunction or defect or that Gore, its employees or agents, or the Gore device caused or contributed
to any complications or injuries. Please see the device Instructions for Use for further information on the device contraindications, warnings,
precautions, and potential adverse events. The program is subject to modification or termination by W. L. Gore  Associates without prior notification
and this program is only applicable for the United States.

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GORE® VIABIL® Short Wire Biliary Endoprosthesis - Product Brochure

  • 1. S H O R T W I R E B I L I A R Y E N D O P R O S T H E S I S Maximize Control. Minimize Migration. New SHORT WIRE Delivery System
  • 2. Improved treatment of biliary strictures The self-expanding, fully-covered metal stent is intended for palliation of malignant strictures in the biliary tree. The GORE® VIABIL® Short Wire Biliary Endoprosthesis is the only fully covered metal stent with anti-migration technology proven to minimize the risk of reintervention. Additionally, it offers substantiated evidence in studies that demonstrate sustained long-term patency. The precision you expect. Non-foreshortening* stent design and short wire delivery system provide optimal deployment positioning. The outcomes you demand. Designed to reduce the risk of migration and premature obstruction, while sustaining long-term patency. The assurance you can count on. With a 0.2% average reported migration rate1 , GORE® VIABIL® Short Wire Biliary Endoprosthesis is backed by a device replacement program if a migration occurs.2 We’re so confident, we now offer an ANTI-MIGRATION ASSURANCE PROGRAM Replacement if a device migrates within one full year post implantation** *If deployed as instructed, the endoprosthesis will not appreciably foreshorten. **See back for the details of the assurance program.
  • 3. Demonstrated low migrations Fully covered anchoring fins Securely holds the device within the duct to minimize the risk of migration, with a reported 0–1.4% migration rate range outperforming BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent migration rates ranging up to 0–13%.1 Optimal Conformability Nitinol Wire based stent design Optimal balance of Radial and Axial force provides the right fit and flexibility to help prevent migration and sludge formation.3,4 Prevents tissue ingrowth and promotes conformability Durable, non-porous FEP/ePTFE liner Prevents tissue ingrowth and promotes conformability. Proven highest patency helps provide a high standard of palliative care for your patients.5,6 1 1 3 2 BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent GORE® VIABIL® Short Wire Biliary Endoprosthesis Precise delivery New short wire delivery system Combined short wire delivery system and stent flexibility provides accurate delivery with optimal positioning and deployment. Non-foreshortening design for precision you can count on. During delivery: • Unlike other stents, eliminates repositioning associated with typical push/pull delivery • Will not appreciably change in length 2 3
  • 4. Anti-migration design Unique anti-migration design features atraumatic anchoring fins to help minimize the risk of migration and mitigate clinical challenges. MIGRATION RATE COMPARISON1 Based on 23 papers published from 2002 to 2015. Unique combination for the treatment of biliary obstruction 0.0% Bezzi M et al. 0.0% Fanelli F et al. 0.0% Hatzidakis A et al. 0.0% Krokidis M et al. 0.0% Irurzun J et al. 0.0% Krokidis M et al. 0.0% Marzio A et al. 0.0% Scheer F et al. 0.0% Schoder M et al. 0.0% Van Steenbergen W 0.0% Zurstrassen CE et al. 1.4% Bakhru M et al. 0–1.4% (0.2%weightedaverage) Siddiqui et al. 5.0% Lee et al. 7.0% Chedid et al. 8.8% Ryozawa et al. 13.0% Kahaleh et al. 1.5% Nakai et al. 0.0% Kitano et al. 0.0% Korenblit et al. 3.9% Sampaziotis et al. 4.7% Petersen et al. 1.7% Ogawa et al. 2.8% BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent 0–13% (4.6%weightedaverage) GORE® VIABIL® Biliary Endoprosthesis Average reported migration rate is ≈ 0.2%.1 We’re so confident, we now offer an ANTI-MIGRATION ASSURANCE PROGRAM Replacement if a device migrates within one full year post implantation
  • 5. Compared to the BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent, the GORE® VIABIL® Biliary Endoprosthesis has low Af and moderate Rf, the preferred combination for reducing migration and achieving higher patency.4 TRAIGHTENING AXIAL FORCE Higher primary patency Clinical performance demonstrates GORE® VIABIL® Biliary Endoprosthesis maintains higher primary patency than the leading competitor at 3, 6, and 12-months.5,6 Improved long-term patency can mean an improved quality of life for patients. Preferred combination Preferred balance of Axial and Radial forces* conform to duct anatomy According to studies by Isayama et al., 2012, stent migration and sludge formation is related to the device conformability in the bile duct, which is influenced by the device’s axial force (Af).3 A balance of low axial force and moderate radial force (Rf) is preferred for optimal performance.4 GORE® VIABIL® Biliary Endoprosthesis is the preferred combination of low Af and moderate Rf to minimize risk of migration, conforming naturally to the bile duct anatomy.4 SEMS with high Af do not conform well in the curved bile duct, increasing the risk of stent migration. Additionally, the duct tends to kink at the proximal edge of the stent, causing sludge formation or cholangitis.3 STRAIGHTENING AXIAL FORCE High axial force Low axial force RadialForce(N) 14 12 10 8 6 4 2 0 Axial Force (mN) 0 20 40 60 80 100 120 GORE® VIABIL® Biliary Device (ø10mn) GORE® VIABIL® Biliary Device (ø8mn) BOSTON SCIENTIFIC WALLFLEX Biliary RX Stent (ø10mn) BOSTON SCIENTIFIC WALLFLEX Biliary RX Stent (ø8mn) 100% 90% 80% 70% 60% 50% 12 months6 months3 months 100% 98.3% 96.2% 84.3% 76.5% 63.5%BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent GORE® VIABIL® Biliary Endoprosthesis * Axial force is the recovery force that leads to straightening after being bent, while Radial force maintains and expands the luminal patency at the stricture once deployed.
  • 6. Economic impact of migration Assume your hospital does 100 endoscopic retrograde cholangiopancreatography (ERCP) with stent placements per year, with the average patient survival for malignant strictures being six months. GORE® VIABIL® Short Wire Biliary Endoprosthesis BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent Migration Rate (average)1 0.2% 4.6% Estimated number of reinterventions to manage migrations (per year) 1 5 Estimated patency at six months5,6 96.2% 84.3% Estimated number of reinterventions to manage loss of patency (per year) 4 16 Total number of reinterventions expected per year 5 21 Estimated additional cost per year due to reinterventions (includes ERCP + Stent cost)* $32,205 $151,221 *Average cost of inpatient ERCP is $4649. Source: National Healthcare payer database, 2015 Gore has used reasonable efforts to ensure the completeness and accuracy of the information contained herein as of the date this document was prepared. Gore is not liable for any claims or actions attributable to the use of this, nor for any errors or omissions involved in the use of the information, or the results. Payment policies are variable depending on the payer, geographic location and provider specific contracts. The models provided here are for illustrative purposes only and are not intended to be indicative of payment from any payer. Potential economic impact If GORE® VIABIL® Short Wire Biliary Endoprosthesis was used to treat 100 patients with unresectable malignant biliary strictures, your institution is estimated to annually: ELIMINATE 16 REINTERVENTIONS due to migrations and reduced patency, and SAVE $116,716 versus using BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent.
  • 7. Sizing and specifications Endoscopic GORE® VIABIL® Short Wire Biliary Endoprosthesis Catalogue Number GORE® VIABIL® Biliary Endoprosthesis Catalogue Number Endoprosthesis Diameter (mm) × Length (cm) Working Length of Delivery Catheter (cm) Drainage Holes Located At the Hilar Region Transmural Drainage Holes Length (cm) VSWVN0804 VN0804200 8 x 4 200 No holes — VSWVN0806 VN0806200 8 x 6 200 No holes — VSWVN0808 VN0808200 8 x 8 200 No holes — VSWVN0810 VN0810200 8 x 10 200 No holes — VSWVN1004 VN1004200 10 x 4 200 No holes — VSWVN1006 VN1006200 10 x 6 200 No holes — VSWVN1008 VN1008200 10 x 8 200 No holes — VSWVN1010 VN1010200 10 x 10 200 No holes — VSWVH0806 VH0806200 8 x 6 200 Holes 2 VSWVH0808 VH0808200 8 x 8 200 Holes 2 VSWVH0810 VH0810200 8 x 10 200 Holes 2 VSWVH1006 VH1006200 10 x 6 200 Holes 2 VSWVH1008 VH1008200 10 x 8 200 Holes 2 VSWVH1010 VH1010200 10 x 10 200 Holes 2 Sizing, availability, and pricing varies by country. Please check with your representative for availability.
  • 8. W. L. Gore Associates, Inc. Flagstaff, AZ 86004 +65.67332882 (Asia Pacific) 800.437.8181 (United States) 00800.6334.4673 (Europe) 928.779.2771 (United States) goremedical.com Products listed may not be available in all markets. WALLFLEX is a trademark of Boston Scientific Corporation GORE® , VIABIL® , and designs are trademarks of W. L. Gore Associates. © 2017 W. L. Gore Associates, Inc. AW0305-EN1 JUNE 2017 REFERENCES 1. W. L. Gore Associates, Inc. Migration Summary for GORE® VIABIL® Biliary Endoprosthesis and BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent. Flagstaff, AZ: W. L. Gore Associates, Inc; 2017. [Literature Summary]. AW0010-EN3. 2. W. L. Gore Associates, Inc. Reduce the risk of reintervention. GORE® VIABIL® Biliary Endoprosthesis Assurance Brochure. Flagstaff, AZ: W. L. Gore Associates, Inc; 2017. [Flyer]. AW0165-EN1. 3. Isayama H, Mukai T, Itoi T, et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointestinal Endoscopy 2012;76(1):84-92. 4. Isayama H, Nakai Y, Toyokawa Y, et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointestinal Endoscopy 2009;70(1):37-44. 5. Kitano M, Yamashita Y, Tanaka K, et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22. 6. Krokidis M, Fanelli F, Orgera G, Bezzi M, Passariello R, Hatzidakis A. Percutaneous treatment of malignant jaundice due to extrahepatic cholangiocarcinoma: covered Viabil stent versus uncovered Wallstents. Cardiovascular Interventional Radiology 2010;33(1):97-106. ANTI-MIGRATION ASSURANCE PROGRAM DETAILS Gore will provide a replacement device of identical dimensions for use with the patient whose device migrates within one year post implantation. The replacement device is only available if GORE® VIABIL® Biliary Endoprosthesis is implanted in accordance with the device Instructions for Use (The GORE® VIABIL® Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree) and the other terms of the program are satisfied. Replacement devices provided under this program are not eligible for the program. Claims under the program are limited to the replacement device. Upon receipt of the appropriate documentation, a replacement device will be provided pursuant to the program accompanied by a no-charge invoice shipped directly to the hospital. The hospital is responsible for reporting the no-charge replacement stent as a discount on the hospital’s cost report. All reports of migration will be documented appropriately within the Gore internal product surveillance process and additional information may be requested. Migrations are a known risk of any biliary endoprosthesis. The provision of a replacement device as part of the program does not constitute an admission that there was a device malfunction or defect or that Gore, its employees or agents, or the Gore device caused or contributed to any complications or injuries. Please see the device Instructions for Use for further information on the device contraindications, warnings, precautions, and potential adverse events. The program is subject to modification or termination by W. L. Gore Associates without prior notification and this program is only applicable for the United States.