One-Year Results Presented From the Gore Viabahn Japan IDE Clinical Study

September 21, 2016—Gore & Associates, Inc. announced positive results from the prospective multicenter investigational device exemption (IDE) clinical study, which occurred in Japan, that evaluated the company’s Viabahn endoprosthesis with heparin bioactive surface. Principal Investigator Prof. Takao Ohki, MD, presented the findings during a Gore symposium hosted in conjunction with VIVA 16, the Vascular InterVentional Advances conference held September 18–22 in Las Vegas, Nevada.

According to the company, the Viabahn device demonstrated excellent outcomes in treating long, complex lesions in the superficial femoral artery, achieving 88% primary patency at 12 months.

The prospective single-arm study enrolled 103 patients for analysis across 15 trial sites. The trial enrolled a challenging patient population with > 10-cm long lesions, including 84.5% TASC II C and D lesions and 65.7% of lesions had chronic total occlusions.

The company noted that these favorable outcomes were consistent with previous clinical studies. Primary patency at 12 months in all lesions (average of 21.8 cm) was 88% and lesions ≤ 20 cm showed 93% primary patency. The study also demonstrated 100% limb salvage with no cases of acute limb ischemia, bypass, or amputation.

In Gore’s press release, Dr. Ohki commented, “Eighty-eight percent is an extremely high primary patency for these long complex lesions with an average length of 22 cm, especially given the scrutiny of the study design: a prospective multicenter IDE clinical study that was core lab adjudicated and reviewed by the Japanese regulatory authority. The Viabahn endoprosthesis, for the first time in endovascular history, may replace bypass surgery for femoropopliteal disease.”