FDAnews Device Daily Bulletin

W.L. Gore: Viabahn Better Than Standard Care for Narrow Blood Vessels

Feb. 24, 2014

Results of the REVISE clinical trial show the Gore Viabahn Endoprosthesis with heparin bioactive surface outperforms percutaneous angioplasty in the treatment of stenosis or thrombotic occlusions, W. L. Gore & Associates says.

According to the Delaware-based chemical company, patients treated with Viabahn had “statistically superior” vessel patency compared with PTA, the current standard of care, during 24 months of follow-up. Noninferiority was demonstrated by on absence of major adverse events compared it the control group. Patients treated with Viabahn also needed fewer repeat interventions, Gore said.

The company presented the results at the 10th Annual Scientific Meeting of the American Society of Diagnostic and Interventional Nephrology Feb. 23 in Phoenix.

“In addition to its proven clinical benefit, the Gore Viabahn Endoprosthesis is both flexible and durable, allowing it to conform to the anatomy of a moving arm and cover every curve,” said Tom Vesely, medical director of the REVISE study. “The device provides physicians with an endovascular tool to treat even the most challenging venous anastomotic locations.”

The FDA approved Viabahn for the stenosis and thrombotic occlusion indications in December. That followed the November approval of a 25 cm version of the Gore Viabahn Endoprosthesis for treating symptomatic peripheral arterial disease lesions in the superficial femoral artery. — Ferdous Al-Faruque

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