Pericardium-covered stents
This article was originally published in The Gray Sheet
Executive Summary
FDA grants humanitarian use device designation to ITGI Medical's Over and Under and AneuGraft equine pericardium-covered stainless steel stents for treatment of perforations and dissections of native coronary arteries and saphenous vein grafts. The pericardium creates a barrier between the blood vessel wall and the lumen, the Israeli company explains. The HUD designation is the first step toward humanitarian device exemption approval. FDA grants HDE approvals for devices that treat a disease affecting 4,000 or fewer patients in the U.S. each year if the sponsor can demonstrate safety and probable benefit. The devices are already available in Europe, Israel and Latin America