W L Gore & Associates (Gore) has announced a positive outcome of the Gore Revise clinical study of Viabahn Endoprosthesis with Heparin Bioactive Surface (Gore Viabahn Endoprosthesis) in AV access graft outflow interventions.
The device is a low profile, flexible, self-expanding, small-diameter endoprosthesis and a stent-graft which has been approved for its usage for superficial femoral artery (SFA), in-stent restenosis of bare-metal stents in the SFA, iliac artery, and AV access.
The Gore Revise Clinical Study is the first AV access stent-graft study to involve patients with thrombosed grafts.
During the study, Gore Viabahn Endoprosthesis was placed across the elbow joint, displaying its functionality during clinical treatment on inaccessible anatomy.
Since its placement, the device has delivered 72% target lesion primary patency at six months and 83% access secondary patency at 24 months.
Arteriovenous grafts (AVG) are created during hemodialysis in end-stage renal disease.
A failed dialysis circuit often necessitates infection-prone central venous catheters (CVCs) and balloon angioplasty which sometimes is rendered ineffective for patients.
However, the study has exhibited a better outcome with minimised interventions following the placement of the Gore Viabahn Endoprosthesis.
St. Louis vascular access services Interventional Radiologist Thomas Vesely said: "Patients with failing dialysis circuits that are unresponsive to balloon angioplasty are a real problem for physicians.
"Historically, angioplasty has been a popular treatment option, but our study found its six-month primary patency rates to be well below the reasonable goal of 50% stated by the 2006 K/DOQI guidelines for vascular access.
"The data shown in the Gore REVISE Clinical Study manuscript makes a compelling argument for GORE VIABAHN Endoprosthesis use in those challenging cases."
The device features a durable, reinforced, biocompatible, expanded polytetrafluorethylene (ePTFE) liner and is connected to an external nitinol stent structure.
It also features Gore's CBAS Heparin Surface based on the proven, lasting heparin bonding technology which resists thrombus formation.
Image: Gore Viabahn Endoprosthesis. Photo: courtesy of Business Wire.