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GORE® PROPATEN® Vascular Graft Below-knee bypass primary patency 

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GORE PROPATEN Vascular Graft Below-knee bypass primary patency

 

* Overall weighted average primary patency is based on data from 10 peer-reviewed publications meeting pre-determined inclusion criteria.

Study size (N) reflects the initial cohort size of the study 

Below-knee data

StudyYearLocationNPrimary Patency 
    Year 1 Year 2 Year 3 Year 4Year 5Year 9
Kaisar et al 2018Infrapopliteal 6285% 71%64% 57%   
Uhl et al 2015Infrapopliteal 8964% 49% 34%   
Neville et al 2014Infrapopliteal 6275%     
Monaca et al 2013Infrapopliteal 212    52%41% 
Dorigo et al 2012BK fem-pop 
Infrapopliteal 
414 
142 
   45% 
39% 
  
Pulli et al 2010BK fem-pop 
Infrapopliteal 
238 
86
75% 
66% 
67% 
57% 
61% 
52% 
   
Daenens et al 2009BK fem-pop 
Infrapopliteal 
57 
97
92% 
79%
83% 
69%
    
Hugl et al 2009BK fem-pop 
Infrapopliteal 
37 
15
74% 
79% 
     
Lösel-Sadée et al 2009BK fem-pop 
Infrapopliteal 
30 
45
77% 
64%
71% 
57% 
71% 
50% 
71% 
50% 
71% 
50%
 
Peeters et al 2008 BK fem-pop 
Infrapopliteal 
41 
37
86% 
71% 
79% 
60% 
75% 
60% 
   

IFU Consult instructions

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

INDICATIONS FOR USE IN EUROPE: GORE® PROPATEN® Vascular Graft is indicated for patients who require replacement or bypass of peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD).

GORE® PROPATEN® Vascular Graft Configured for Pediatric Shunt is indicated for staged palliative repair of cyanotic congenital heart disease (CCHD).

CONTRAINDICATIONS: DO NOT use the GORE® PROPATEN® Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.

DO NOT use any of the below configurations of GORE® PROPATEN® Vascular Graft for coronary artery bypass or cerebral reconstruction procedures:

  • GORE® PROPATEN® Vascular Graft Integrated Rings
  • GORE® PROPATEN® Vascular Graft Fixed Ring
  • GORE® PROPATEN® Vascular Graft Removable Ring
  • GORE® PROPATEN® Vascular Graft Removable Ring Axillobifemoral

DO NOT use GORE® PROPATEN® Vascular Graft as a patch. If cut and used as a patch, GORE® PROPATEN® Vascular Graft may lack adequate transverse strength.

FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE® ACUSEAL Cardiovascular Patch.

Product may not be available in all countries. Please check with your Gore representative for availability.