FDA Clears Malin's Hourglass Peripheral Embolization Plug
August 22, 2017—Malin Corporation plc, an Ireland-based company, announced that its Hourglass peripheral embolization plug was granted US Food and Drug Administration 510(k) clearance to commence marketing in the United States. The company stated that the Hourglass device is designed to provide precise, secure, over-the-wire delivery and immediate occlusion in a single integrated device. The device received European CE Mark approval in 2015.
In the company's announcement, Andrew Cragg, MD, commented, "The Hourglass device is designed to provide immediate occlusion in a wide range of vessel sizes with a single device. The device's unique design was created to take advantage of natural hemodynamic forces to provide immediate, focal, stable occlusions." Dr. Cragg, a Co-Developer of Hourglass, is an interventional radiologist in Minneapolis, Minnesota. The Hourglass device was a product of Emba Medical Limited, which Malin acquired in 2015.