FDA has Granted HUD (Humanitarian Use Device) Designation to ITGI's Pericardium Covered Stents, Over and Under(R) and Aneugraft(R), for Treatment of Perforations and Dissections of Native Coronary Arteries and Saphenous Vein Grafts.

PR Newswire | April 28, 2009 | Copyright

OR AKIVA, Israel, April 28 /PRNewswire-FirstCall/ -- ITGI Medical, Ltd. 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 ...

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