FDA has Granted HUD (Humanitarian Use Device) Designation to ITGI's Pericardium Covered Stents, Over and Under(R) and Aneugraft(R)

OR AKIVA, Israel, April 28 (HSMN NewsFeed) -- ITGI Medical, Ltd. (TASE: ITGI) a company engaged in research, development, manufacturing and marketing of heterologous tissue covered stents, announced that the US Food and Drug Administration (FDA) has granted HUD (Humanitarian Use Device) designation to Over and Under(R) and Aneugraft(R) Pericardium Covered Stents for treatment of perforations and dissections of native coronary arteries and Saphenous Vein Grafts.

This is the first step towards obtaining marketing approval.Over and Under(R) and AneuGraft(R) are stents 100% covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. 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.

Full text >>