ITGI Medical, based in Or Akiva, Israel, just received the Humanitarian Use Device designation, an initial step in receiving marketing approval, for the firm’s two coronary stenting systems. The pericardium covered stents include the AneuGraft (pictured), already approved in Europe, which is designed for tortuous arteries, and the Over and Under which is indicated for “post PTCA treatment of Saphenous Vein Graft (SVG) stenosis, aneurysms and for emergency situations such as perforations”.
Here’s a company video introducing the Over and Under:
Flashbacks: AneuGraft Stent from ITGI Medical Wins Approval in Europe ; Over and Under Pericardium Covered Stent from ITGI Medical
Product page: ITGI Medical Coronary…
(hat tip: Globes [online])