Florida-based stent maker Bolton Medical won FDA clearance for its thoracic-specific stent-graft system, the company announced today.
Bolton’s Relay thoracic stent-graft device and delivery system is designed specifically for minimally invasive treatment of thoracic aortic aneurysms and penetrating atherosclerotic ulcers, and it comes in a range of sizes, according to a press release.
The devices have long been cleared by European regulators, and in 2009 Bolton won additional approval for its Relay Plus delivery system.
"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," CEO Oscar Rospigliosi said in prepared remarks. "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."
About 7,000 of Bolton’s Relay and Relay NBS thoracic stent-grafts have been implanted worldwide, according to a press release.