DUBLIN--(BUSINESS WIRE)--EMBA Medical™ Limited announced today that the company has received CE certification for its revolutionary peripheral embolization device. The device, known as the 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.
“This is the first integrated, over-the-wire device designed for peripheral embolization procedures,” said George Wallace, CEO of EMBA Medical™ Limited. “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, MD, a Minneapolis, MN, USA-based 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 hemodynamic forces to provide immediate, focal, stable occlusions.”
The Hourglass™ Peripheral Embolization Plug is a class IIb medical device and will be manufactured in the EMBA Medical™ Limited ISO-certified manufacturing facility in Miramar, Florida, USA. The facility received ISO certification (ISO 13485:2003) on July 10, 2015. The device is not approved for sale in the United States.
EMBA Medical™ Limited is a Dublin, Ireland, domiciled medical device company that designs and develops innovative peripheral embolization technologies focused on improving safety, control, and outcomes. Ireland-based Malin Corporation plc, a global life sciences company, is the lead investor in EMBA Medical™. Intersect Partners, a medical device incubator with extensive experience in vascular interventions, is the developer of the technology. EMBA Medical™ Limited is located at Block 2 Harbour Square, Crofton Road, Dun Laoghaire, Dublin, Ireland. EMBA Medical and Hourglass are trademarks of EMBA Medical, Inc.
The company can be contacted at info@EMBAmedical.com.