ITGI pericardium stents net FDA HUD

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The FDA has granted Humanitarian Use Device (HUD) designation to ITGI Medical's Over and Under and Aneugraft pericardium-covered stents for treatment of perforations and dissections of native coronary arteries and saphenous vein grafts.

The Or Akiva, Israel-based ITGI said its Over and Under and AneuGraft are stents covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. The company's stents are commercially available in Europe, Israel and Latin America for treatment of saphenous vein graft stenosis, aneurysms and for emergency situations, such as perforations.