ITGI Signs Strategic Cooperation Deal With Vascular Solutions

(RTTNews) - ITGI (ITGI) on Monday announced the initiation of its activity in the U.S. market, with the company inking a strategic cooperation agreement with Vascular Solutions Inc. (VASC), a company engaged in the cardiolog device market.

As per the deal, the companies will collaborate to complete a U.S. development program and apply to the Food and Drug Administration for approval under the Humanitarian Device Exemption process for ITGI's novel Aneugraft Dx coronary covered stent.

Upon approval, Vascular Solutions will distribute ITGI's coronary stent in the U.S. for use in the treatment of perforations and dissections of native coronary arteries, coronary aneurysms, and diseased saphenous vein grafts.

Under the U.S. clinical development program, ITGI will be responsible for the pre-clinical research phase, while Vascular Solutions will be responsible for all communications with the FDA and the execution of the clinical study in the U.S.

ITGI expects the U.S. development program to start during the first quarter of 2014 and expects the development and review process to take approximately two and a half to three years.

The coronary covered stent developed by ITGI (Aneugraft Dx) is a unique stent that has been engineered to allow easy, convenient navigation and deployment, with a flexible delivery system that allows tracking through tortuous blood vessels. The marketing of the stent commenced in 2011 in Europe after receiving CE approval.

ITGI deals with the fields of research and development and manufacturing of pericardium covered stents.