ITGI announces today the initiation of its activity in the
U.S. market. The company has signed a strategic cooperation agreement
with U.S.-based Vascular Solutions, Inc. VASC, an international
leader in the interventional cardiology device market. 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 (HDE) 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.
See full press release
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