FDA Approves Bolton Medical's Relay Thoracic Stent Graft

September 24, 2012—Bolton Medical, Inc. (Sunrise, FL) announced that the US Food and Drug Administration has approved the company's Relay thoracic stent graft with Plus delivery system.

According to Bolton Medical's press release, the Relay device is specifically designed for the thoracic aorta and is offered in a wide range of sizes to expand the use of this endovascular treatment for thoracic aortic aneurysms and penetrating atherosclerotic ulcers. The Relay system features distinct performance zones for varying levels of radial support and apposition, a four-step dual-sheath delivery system, and a wide range of sizes with lengths of 100 to 250 mm and diameters of 22 to 46 mm, straight and tapered.

Bolton Medical noted that its stent grafts have been used in Europe and other international markets since 2005. The company advised that the United States pivotal study of the device included 120 endovascular patients at 30 hospitals across the country.

Mark A. Farber, MD, served as National Principal Investigator for the trial. He is the Director of the University of North Carolina's Aortic Center and Vascular Surgery Program Director.

“The Relay thoracic stent graft allows for precision and conformability, especially in patients with more challenging anatomies,” commented Dr. Farber. “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.”