FDA approves the Gore Viabahn endoprosthesis to treat peripheral artery disease

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Gore announced it has received FDA approval for the Gore Viabahn endoprosthesis with heparin bioactive surface on a lower profile delivery system. This device is designed to percutaneously treat peripheral artery disease by relining the native vessel.

This next generation device enables a reduction in delivery profile to 6 Fr for 5 and 6mm devices and 7 Fr for 7 and 8mm devices and is delivered over a 0.018” or 0.014” guidewire. No changes have been made to the endoprosthesis. The reduced delivery profile will provide interventionalists with greater options for delivery with the same trackability and device performance in treating stenoses and occlusions of the superficial femoral artery and iliac artery.

“While most technology has stagnated over the past several years, Gore continues to optimise the Gore Viabahn endoprosthesis which allows physicians to broaden the potential patient population that we can treat,” said Gary Ansel, interventional cardiologist at Riverside Methodist Hospital, Columbus, Ohio, USA.

The Gore Viabahn with heparin bioactive is the only stent-graft approved for use in the superficial femoral artery and iliac artery. The new device is available with a 120cm long delivery catheter and incorporates the Carmeda BioActive surface, which utilises end-point immobilisation of derivatised heparin to the endoprosthesis luminal surface. This proprietary surface technology preserves the heparin bioactive sites such that they remain free to interact with the blood at the device surface without being consumed.

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