Malin Corporation announced it has secured FDA 510(k) clearance for its Hourglass Peripheral Embolization Plug.
The device allows physicians to provide secure, over-the-wire delivery and immediate occlusion in one device. It is already approved in Europe.
The device is designed to provide physicians with accurate, stent-like delivery. The plug has also undergone clinical studies in several interventional cases in Ireland and New Zealand, according to the company.