Emba Medical said today it won CE Mark approval in the European Union for its Hourglass peripheral embolization plug device.
The Dublin, Ireland-based embolization plug maker said the device features over-the-wire delivery, which the company claims increases precision of placement.
“This is the 1st integrated, over-the-wire device designed for peripheral embolization procedures. The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel. We believe that the Hourglass implant will provide a level of confidence, precision, and control for peripheral embolization procedures that physicians have come to enjoy over the years while performing other types of over-the-wire endovascular procedures,” CEO George Wallace said in a press release.
The product is being manufactured in Miramar, Florida, the company said. Emba Medical’s Hourglass is currently not FDA approved within the U.S.
“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,” Hourglass co-developer Dr. Andrew Cragg said in prepared remarks.
Last June, Emba Medical raised $2.3 million in an equity funding round with 31 unnamed participants, according to an SEC filing.