Bolton Medical announced today that they have received approval from the U.S. Food and Drug Administration for the Relay Thoracic Stent-Graft with Plus Delivery System.
Specifically designed for the thoracic aorta, the Relay device is offered in a wide range of sizes to help to expand the use of this minimally-invasive treatment for thoracic aortic aneurysms and penetrating atherosclerotic ulcers.
Bolton Medical stent-grafts have been widely used in Europe and other international markets since 2005 and, to date, more than 7,000 Relay and Relay NBS Thoracic Stent-Grafts have been implanted worldwide. The U.S. pivotal study included 120 endovascular patients at 30 hospitals across the country.
National Principal Investigator, Dr. Mark Farber, Director, UNC Aortic Center; Vascular Surgery Program Director; Associate Professor of Surgery and Radiology stated, “The Relay Thoracic Stent-Graft allows for precision and conformability, especially in patients with more challenging anatomies. As a physician, I find that the Relay device makes it easier for me to offer this life-saving treatment to a broader population of patients suffering from thoracic aortic aneurysm.”
The Relay system offers the following features:
- Distinct performance zones provide varying levels of radial support and apposition.
- Four-step dual sheath delivery system.
- Wide range of sizes to meet patient needs: lengths of 100mm-250mm, diameters of 22-46mm, straight and tapered.
“With worldwide experience of the Relay family of devices, we are pleased that the FDA has now approved the use of this device in the United States. We believe that U.S. physicians will benefit tremendously from access to the latest medical technology of the Relay Thoracic Stent-Graft with Plus Delivery System,” said Oscar Rospigliosi, CEO, Bolton Medical, Inc.
Source: Bolton Medical