www.fdanews.com/articles/183230-malin-corporation-gets-marketing-clearance-for-peripheral-embolization-plug
Malin Corporation Gets Marketing Clearance for Peripheral Embolization Plug
August 24, 2017
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.