FDA Grants HUD Designation for Pericardium Covered Stents for Perforations, Dissections of Coronaries, Vein Grafts
May 5, 2009 - ITGI Medical Ltd. Said last week the FDA granted HUD (humanitarian use device) designation to Over and Under and Aneugraft pericardium covered stents for treatment of perforations and dissections of native coronary arteries and saphenous vein grafts.
HUD is the first step towards obtaining market approval from the FDA, the company said.
The Over and Under and AneuGraft are stents that are covered 100 percent with a heterologous tissue designed as 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.
Pericardium covered stents are unique stents covered with heterologous tissue designed to set a barrier between the blood vessel wall and its lumen. Pericardium covered stents are indicated for treatment of bypass stenosis, aneurysms and for emergency situations such as perforations.
ITGI medical is engaged in research and development, manufacturing and marketing of heterologous tissue covered stents.
For more information: www.itgimedical.com