Emba Medical has announced receiving the European CE mark for the Hourglass peripheral embolization plug making the device the first over-the-wire embolic device cleared for EU commercial release.
Hourglass peripheral embolization plug was awarded a CE certificate on July 10, 2015, enabling the company to pursue commercial activities in EU nations. The Hourglass device represents a breakthrough in peripheral embolization devices in that it is designed to provide precise, secure, over-the-wire delivery and immediate occlusion with a single integrated device, a press release from the company states.
“This is the first integrated, over-the-wire device designed for peripheral embolization procedures,” said George Wallace, CEO of Emba Medical. “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.”
Andrew Cragg (Minneapolis, USA) interventional radiologist and Hourglass co-developer, noted: “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 haemodynamic forces to provide immediate, focal, stable occlusions.”
The device is not approved for sale in the United States.