Vascular Solutions signs 'cooperation agreement' to get ITGI's stent on the U.S. market

November 18, 2013 by Arezu Sarvestani

Vascular Solutions and ITGI Medical announce a "cooperation agreement" in pursuit of FDA Humanitarian Device Exemption for ITGI's Aneugraft Dx coronary covered stent.

Vascular Solutions signs 'cooperation agreement' to get ITGI's stent on the U.S. market

Stent makers Vascular Solutions (NSDQ:VASC) and ITGI Medical Ltd. (TASE:ITGI) joined forces this week in pursuit of regulatory and commercial progress for ITGI's Aneugraft Dx coronary covered stent.

Under the terms of the agreement Vascular Solutions will become the exclusive U.S. distributor for the Aneugraft Dx system when it lands market approval, and the companies are sharing development costs. The project is slated to begin in Q1 2014 and should take 2-3.5 years, the companies said.

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The duo is hoping to land FDA Humanitarian Device Exemption for Aneugraft Dx "in the treatment of perforations and dissections of native coronary arteries, coronary aneurysms, and diseased saphenous vein grafts."
ITGI is handling the pre-clinical research phase of development and Vascular Solutions will handle all FDA communications and executive the U.S. clinical trial, according to a company statement.

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