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Gore also received approval from the FDA for a modification to it's manufacturing process of the GORE VIABAHN® Endoprosthesis. The modification is a result of implementation of the precision laser trimming technology which enables the removal of excess material at the device margin. This change affects all diameters (5 - 13 mm) of the currently approved GORE VIABAHN® Endoprosthesis and GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface. The removal of the excess material at the proximal end improved device apposition to the vessel wall in those circumstances where oversizing does not allow complete expansion of the endoprosthesis. This improved apposition to the vessel wall may improve the flow dynamics of the blood entering the endoprosthesis.
"The recent modifications to the GORE VIABAHN® Endoprosthesis underscores our commitment to continually provide our customers with next generation, innovative products for the treatment of Peripheral Arterial Disease (PAD) in the iliac and superficial femoral arteries," said Erin Hutchinson with the Gore Peripheral Vascular Business. "Gore is fully committed to the ongoing development of this product so that interventionalists can continue to treat their patients with the most up-to-date, innovative solution." |
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