SlideShare a Scribd company logo
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.

More Related Content

What's hot

Cross pinning implants by Mike Tapealava
Cross pinning implants by Mike TapealavaCross pinning implants by Mike Tapealava
Cross pinning implants by Mike Tapealava
Mike Tapealava
 
Bone grafting
Bone graftingBone grafting
Bone grafting
Patnaik Gourishankar
 
Bone augmentation for implants / orthodontics training courses
Bone augmentation for implants / orthodontics training coursesBone augmentation for implants / orthodontics training courses
Bone augmentation for implants / orthodontics training courses
Indian dental academy
 
Bone grafts and growth factors implantology
Bone grafts and growth factors implantologyBone grafts and growth factors implantology
Bone grafts and growth factors implantology
Dr. vasavi reddy
 
H ridge augmentation with a collagen membrane and combination of particulated...
H ridge augmentation with a collagen membrane and combination of particulated...H ridge augmentation with a collagen membrane and combination of particulated...
H ridge augmentation with a collagen membrane and combination of particulated...
threea3a
 
Selection of bone grafts in periodontics
Selection of bone grafts in periodonticsSelection of bone grafts in periodontics
Selection of bone grafts in periodontics
R Viswa Chandra
 
ACM poster from Michigan University
ACM poster from Michigan UniversityACM poster from Michigan University
ACM poster from Michigan University
Kei Lim
 
BONE GRAFTS
BONE GRAFTSBONE GRAFTS
BONE GRAFTS
DR. REBICCA RANJIT
 
bone graft /certified fixed orthodontic courses by Indian dental academy
 bone graft /certified fixed orthodontic courses by Indian dental academy  bone graft /certified fixed orthodontic courses by Indian dental academy
bone graft /certified fixed orthodontic courses by Indian dental academy
Indian dental academy
 
Bone grafts in dentistry
Bone grafts in dentistryBone grafts in dentistry
Bone grafts in dentistry
KirtiRanka1
 
Bone grafts and periodontal
Bone grafts and periodontalBone grafts and periodontal
Bone grafts and periodontal
Navneet Randhawa
 
bone graft
bone graftbone graft
bone graft
Khaldoon Hassan
 
Bone grafts
Bone graftsBone grafts
Bone grafts
Murtaza Kaderi
 
Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...
Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...
Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...
Indian dental academy
 
Biotec Dental Implants Product Catalog 2019
Biotec Dental Implants Product Catalog 2019Biotec Dental Implants Product Catalog 2019
Biotec Dental Implants Product Catalog 2019
HikmatNajjar
 
Prosthetic guide - 151210 update
Prosthetic guide - 151210 updateProsthetic guide - 151210 update
Prosthetic guide - 151210 update
Kei Lim
 
Immediate Implants
Immediate ImplantsImmediate Implants
Immediate Implants
Jehan Dordi
 
Cranioplasty portfolio
Cranioplasty portfolio Cranioplasty portfolio
Cranioplasty portfolio
Dan Melendez
 
Prosthetic platforms in implant dentistry
Prosthetic platforms in implant dentistryProsthetic platforms in implant dentistry
Prosthetic platforms in implant dentistry
Bryan Luis
 
Autogenous bone graft harvesting
Autogenous bone graft harvestingAutogenous bone graft harvesting
Autogenous bone graft harvesting
Rakesh Chandran
 

What's hot (20)

Cross pinning implants by Mike Tapealava
Cross pinning implants by Mike TapealavaCross pinning implants by Mike Tapealava
Cross pinning implants by Mike Tapealava
 
Bone grafting
Bone graftingBone grafting
Bone grafting
 
Bone augmentation for implants / orthodontics training courses
Bone augmentation for implants / orthodontics training coursesBone augmentation for implants / orthodontics training courses
Bone augmentation for implants / orthodontics training courses
 
Bone grafts and growth factors implantology
Bone grafts and growth factors implantologyBone grafts and growth factors implantology
Bone grafts and growth factors implantology
 
H ridge augmentation with a collagen membrane and combination of particulated...
H ridge augmentation with a collagen membrane and combination of particulated...H ridge augmentation with a collagen membrane and combination of particulated...
H ridge augmentation with a collagen membrane and combination of particulated...
 
Selection of bone grafts in periodontics
Selection of bone grafts in periodonticsSelection of bone grafts in periodontics
Selection of bone grafts in periodontics
 
ACM poster from Michigan University
ACM poster from Michigan UniversityACM poster from Michigan University
ACM poster from Michigan University
 
BONE GRAFTS
BONE GRAFTSBONE GRAFTS
BONE GRAFTS
 
bone graft /certified fixed orthodontic courses by Indian dental academy
 bone graft /certified fixed orthodontic courses by Indian dental academy  bone graft /certified fixed orthodontic courses by Indian dental academy
bone graft /certified fixed orthodontic courses by Indian dental academy
 
Bone grafts in dentistry
Bone grafts in dentistryBone grafts in dentistry
Bone grafts in dentistry
 
Bone grafts and periodontal
Bone grafts and periodontalBone grafts and periodontal
Bone grafts and periodontal
 
bone graft
bone graftbone graft
bone graft
 
Bone grafts
Bone graftsBone grafts
Bone grafts
 
Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...
Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...
Implants & prosthetics / /certified fixed orthodontic courses by Indian denta...
 
Biotec Dental Implants Product Catalog 2019
Biotec Dental Implants Product Catalog 2019Biotec Dental Implants Product Catalog 2019
Biotec Dental Implants Product Catalog 2019
 
Prosthetic guide - 151210 update
Prosthetic guide - 151210 updateProsthetic guide - 151210 update
Prosthetic guide - 151210 update
 
Immediate Implants
Immediate ImplantsImmediate Implants
Immediate Implants
 
Cranioplasty portfolio
Cranioplasty portfolio Cranioplasty portfolio
Cranioplasty portfolio
 
Prosthetic platforms in implant dentistry
Prosthetic platforms in implant dentistryProsthetic platforms in implant dentistry
Prosthetic platforms in implant dentistry
 
Autogenous bone graft harvesting
Autogenous bone graft harvestingAutogenous bone graft harvesting
Autogenous bone graft harvesting
 

Similar to GORE® VIABIL® Short Wire Biliary Endoprosthesis - Product Brochure

Implants And Prosthetics
Implants And ProstheticsImplants And Prosthetics
Implants And Prosthetics
shabeel pn
 
Short Implants and their role in prosthetic replacement of missing tooth
Short Implants and their role in prosthetic replacement of missing toothShort Implants and their role in prosthetic replacement of missing tooth
Short Implants and their role in prosthetic replacement of missing tooth
SivaRaman Sms
 
Implant supported over dentures / lingual orthodontics courses in india
Implant supported over dentures / lingual orthodontics courses in indiaImplant supported over dentures / lingual orthodontics courses in india
Implant supported over dentures / lingual orthodontics courses in india
Indian dental academy
 
Copy of implant supported overdenturespp/ dentistry schools
Copy of implant supported overdenturespp/ dentistry schoolsCopy of implant supported overdenturespp/ dentistry schools
Copy of implant supported overdenturespp/ dentistry schools
Indian dental academy
 
Piis1553465012002166
Piis1553465012002166Piis1553465012002166
Piis1553465012002166
Sandip Datta Roy
 
JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...
JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...
JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...
NAMITHA ANAND
 
Implant supported over dentures / oral surgery courses
Implant supported over dentures  / oral surgery courses  Implant supported over dentures  / oral surgery courses
Implant supported over dentures / oral surgery courses
Indian dental academy
 
Implant supported overdentures/dental courses
Implant supported overdentures/dental coursesImplant supported overdentures/dental courses
Implant supported overdentures/dental courses
Indian dental academy
 
MAXILLOFACIAL 2.pptx
MAXILLOFACIAL 2.pptxMAXILLOFACIAL 2.pptx
MAXILLOFACIAL 2.pptx
drayeshasadaf
 
Flapless implant surgery
Flapless implant surgeryFlapless implant surgery
Flapless implant surgery
Dr Ripunjay Tripathi
 
PI-424803-AA Eluvia In-Service (FINAL).pptx
PI-424803-AA Eluvia In-Service (FINAL).pptxPI-424803-AA Eluvia In-Service (FINAL).pptx
PI-424803-AA Eluvia In-Service (FINAL).pptx
reman1184
 
Zest brochure l7010
Zest brochure l7010Zest brochure l7010
Zest brochure l7010
Centric Learning
 
Au0525 eu1.vbn.vascularspecialist.ad.fnl
Au0525 eu1.vbn.vascularspecialist.ad.fnlAu0525 eu1.vbn.vascularspecialist.ad.fnl
Au0525 eu1.vbn.vascularspecialist.ad.fnl
Salutaria
 
All on 4 and all on 6
All on 4 and all on 6All on 4 and all on 6
All on 4 and all on 6
DR PAAVANA
 
Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...
Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...
Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...
Julio Plata
 
Enteral stents
Enteral stentsEnteral stents
Enteral stents
Varun Karri
 
Corticotomy in the Modern Orthodontics
Corticotomy in the Modern OrthodonticsCorticotomy in the Modern Orthodontics
Corticotomy in the Modern Orthodontics
Abu-Hussein Muhamad
 
Corticotomy in the Modern Orthodontics
Corticotomy in the Modern OrthodonticsCorticotomy in the Modern Orthodontics
Corticotomy in the Modern Orthodontics
iosrjce
 
Biomechanics and Treatment Planning
Biomechanics and Treatment PlanningBiomechanics and Treatment Planning
A Review of Atherectomy in Peripheral Arterial Disease
A Review of Atherectomy in Peripheral Arterial DiseaseA Review of Atherectomy in Peripheral Arterial Disease
A Review of Atherectomy in Peripheral Arterial Disease
asclepiuspdfs
 

Similar to GORE® VIABIL® Short Wire Biliary Endoprosthesis - Product Brochure (20)

Implants And Prosthetics
Implants And ProstheticsImplants And Prosthetics
Implants And Prosthetics
 
Short Implants and their role in prosthetic replacement of missing tooth
Short Implants and their role in prosthetic replacement of missing toothShort Implants and their role in prosthetic replacement of missing tooth
Short Implants and their role in prosthetic replacement of missing tooth
 
Implant supported over dentures / lingual orthodontics courses in india
Implant supported over dentures / lingual orthodontics courses in indiaImplant supported over dentures / lingual orthodontics courses in india
Implant supported over dentures / lingual orthodontics courses in india
 
Copy of implant supported overdenturespp/ dentistry schools
Copy of implant supported overdenturespp/ dentistry schoolsCopy of implant supported overdenturespp/ dentistry schools
Copy of implant supported overdenturespp/ dentistry schools
 
Piis1553465012002166
Piis1553465012002166Piis1553465012002166
Piis1553465012002166
 
JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...
JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...
JOURNAL CLUB PRESENTATION IN PROSTHODONTICS on HYPERBARIC OXYGEN THERAPY FOR ...
 
Implant supported over dentures / oral surgery courses
Implant supported over dentures  / oral surgery courses  Implant supported over dentures  / oral surgery courses
Implant supported over dentures / oral surgery courses
 
Implant supported overdentures/dental courses
Implant supported overdentures/dental coursesImplant supported overdentures/dental courses
Implant supported overdentures/dental courses
 
MAXILLOFACIAL 2.pptx
MAXILLOFACIAL 2.pptxMAXILLOFACIAL 2.pptx
MAXILLOFACIAL 2.pptx
 
Flapless implant surgery
Flapless implant surgeryFlapless implant surgery
Flapless implant surgery
 
PI-424803-AA Eluvia In-Service (FINAL).pptx
PI-424803-AA Eluvia In-Service (FINAL).pptxPI-424803-AA Eluvia In-Service (FINAL).pptx
PI-424803-AA Eluvia In-Service (FINAL).pptx
 
Zest brochure l7010
Zest brochure l7010Zest brochure l7010
Zest brochure l7010
 
Au0525 eu1.vbn.vascularspecialist.ad.fnl
Au0525 eu1.vbn.vascularspecialist.ad.fnlAu0525 eu1.vbn.vascularspecialist.ad.fnl
Au0525 eu1.vbn.vascularspecialist.ad.fnl
 
All on 4 and all on 6
All on 4 and all on 6All on 4 and all on 6
All on 4 and all on 6
 
Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...
Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...
Periodontology 2000 - 2023 - Yu - Simultaneous or staged lateral ridge augmen...
 
Enteral stents
Enteral stentsEnteral stents
Enteral stents
 
Corticotomy in the Modern Orthodontics
Corticotomy in the Modern OrthodonticsCorticotomy in the Modern Orthodontics
Corticotomy in the Modern Orthodontics
 
Corticotomy in the Modern Orthodontics
Corticotomy in the Modern OrthodonticsCorticotomy in the Modern Orthodontics
Corticotomy in the Modern Orthodontics
 
Biomechanics and Treatment Planning
Biomechanics and Treatment PlanningBiomechanics and Treatment Planning
Biomechanics and Treatment Planning
 
A Review of Atherectomy in Peripheral Arterial Disease
A Review of Atherectomy in Peripheral Arterial DiseaseA Review of Atherectomy in Peripheral Arterial Disease
A Review of Atherectomy in Peripheral Arterial Disease
 

Recently uploaded

一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
gjsma0ep
 
HUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COM
HUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COMHUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COM
HUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COM
priyabhojwani1200
 
Luxurious Spa In Ajman Chandrima Massage Center
Luxurious Spa In Ajman Chandrima Massage CenterLuxurious Spa In Ajman Chandrima Massage Center
Luxurious Spa In Ajman Chandrima Massage Center
Chandrima Spa Ajman
 
Hypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in itHypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in it
Vishal kr Thakur
 
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
nirahealhty
 
Top massage center in ajman chandrima Spa
Top massage center in ajman chandrima  SpaTop massage center in ajman chandrima  Spa
Top massage center in ajman chandrima Spa
Chandrima Spa Ajman
 
Letter to MREC - application to conduct study
Letter to MREC - application to conduct studyLetter to MREC - application to conduct study
Letter to MREC - application to conduct study
Azreen Aj
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
Vishal kr Thakur
 
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DR Jag Mohan Prajapati
 
Professional Secrecy: Forensic Medicine Lecture
Professional Secrecy: Forensic Medicine LectureProfessional Secrecy: Forensic Medicine Lecture
Professional Secrecy: Forensic Medicine Lecture
DIVYANSHU740006
 
Time line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGY
Time line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGYTime line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGY
Time line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGY
DianaRodriguez639773
 
CANSA support - Caring for Cancer Patients' Caregivers
CANSA support - Caring for Cancer Patients' CaregiversCANSA support - Caring for Cancer Patients' Caregivers
CANSA support - Caring for Cancer Patients' Caregivers
CANSA The Cancer Association of South Africa
 
Common Challenges in Dermatology Billing and How to Overcome.pptx
Common Challenges in Dermatology Billing and How to Overcome.pptxCommon Challenges in Dermatology Billing and How to Overcome.pptx
Common Challenges in Dermatology Billing and How to Overcome.pptx
patriciaava1998
 
DRAFT Ventilator Rapid Reference version 2.4.pdf
DRAFT Ventilator Rapid Reference  version  2.4.pdfDRAFT Ventilator Rapid Reference  version  2.4.pdf
DRAFT Ventilator Rapid Reference version 2.4.pdf
Robert Cole
 
Bringing AI into a Mid-Sized Company: A structured Approach
Bringing AI into a Mid-Sized Company: A structured ApproachBringing AI into a Mid-Sized Company: A structured Approach
Bringing AI into a Mid-Sized Company: A structured Approach
Brian Frerichs
 
2024 HIPAA Compliance Training Guide to the Compliance Officers
2024 HIPAA Compliance Training Guide to the Compliance Officers2024 HIPAA Compliance Training Guide to the Compliance Officers
2024 HIPAA Compliance Training Guide to the Compliance Officers
Conference Panel
 
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Levi Shapiro
 
Vicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdfVicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdf
Arunima620542
 
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURYDR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
SHAMIN EABENSON
 
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdfComprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Dr Rachana Gujar
 

Recently uploaded (20)

一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
一比一原版(EUR毕业证)鹿特丹伊拉斯姆斯大学毕业证如何办理
 
HUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COM
HUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COMHUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COM
HUMAN BRAIN.pptx.PRIYA BHOJWANI@GAMIL.COM
 
Luxurious Spa In Ajman Chandrima Massage Center
Luxurious Spa In Ajman Chandrima Massage CenterLuxurious Spa In Ajman Chandrima Massage Center
Luxurious Spa In Ajman Chandrima Massage Center
 
Hypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in itHypotension and role of physiotherapy in it
Hypotension and role of physiotherapy in it
 
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...
 
Top massage center in ajman chandrima Spa
Top massage center in ajman chandrima  SpaTop massage center in ajman chandrima  Spa
Top massage center in ajman chandrima Spa
 
Letter to MREC - application to conduct study
Letter to MREC - application to conduct studyLetter to MREC - application to conduct study
Letter to MREC - application to conduct study
 
Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.Pneumothorax and role of Physiotherapy in it.
Pneumothorax and role of Physiotherapy in it.
 
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
DELIRIUM BY DR JAGMOHAN PRAJAPATI.......
 
Professional Secrecy: Forensic Medicine Lecture
Professional Secrecy: Forensic Medicine LectureProfessional Secrecy: Forensic Medicine Lecture
Professional Secrecy: Forensic Medicine Lecture
 
Time line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGY
Time line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGYTime line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGY
Time line.ppQAWSDRFTGYUIOPÑLKIUYTREWASDFTGY
 
CANSA support - Caring for Cancer Patients' Caregivers
CANSA support - Caring for Cancer Patients' CaregiversCANSA support - Caring for Cancer Patients' Caregivers
CANSA support - Caring for Cancer Patients' Caregivers
 
Common Challenges in Dermatology Billing and How to Overcome.pptx
Common Challenges in Dermatology Billing and How to Overcome.pptxCommon Challenges in Dermatology Billing and How to Overcome.pptx
Common Challenges in Dermatology Billing and How to Overcome.pptx
 
DRAFT Ventilator Rapid Reference version 2.4.pdf
DRAFT Ventilator Rapid Reference  version  2.4.pdfDRAFT Ventilator Rapid Reference  version  2.4.pdf
DRAFT Ventilator Rapid Reference version 2.4.pdf
 
Bringing AI into a Mid-Sized Company: A structured Approach
Bringing AI into a Mid-Sized Company: A structured ApproachBringing AI into a Mid-Sized Company: A structured Approach
Bringing AI into a Mid-Sized Company: A structured Approach
 
2024 HIPAA Compliance Training Guide to the Compliance Officers
2024 HIPAA Compliance Training Guide to the Compliance Officers2024 HIPAA Compliance Training Guide to the Compliance Officers
2024 HIPAA Compliance Training Guide to the Compliance Officers
 
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
Michigan HealthTech Market Map 2024 with Policy Makers, Academic Innovation C...
 
Vicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdfVicarious movements or trick movements_AB.pdf
Vicarious movements or trick movements_AB.pdf
 
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURYDR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
 
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdfComprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
Comprehensive Rainy Season Advisory: Safety and Preparedness Tips.pdf
 

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.