FDA clears way for thoracic stent-graft

The FDA approved Bolton Medical’s thoracic stent-graft and delivery system as a treatment for thoracic aortic aneurysms and penetrating atherosclerotic ulcers.

The Relay Thoracic Stent-Graft with Plus Delivery System is offered in lengths of 100mm to 250mm, diameters of 22mm to 46mm, and straight and tapered. Other features include performance zones that provide varying levels of radial support and apposition, a four-step dual sheath delivery system.

Bolton Medical stent-grafts have been used in Europe and other international markets since 2005.

The Relay Thoracic Stent-Graft with Plus Delivery System is approved for an open surgery in patients who have a fusiform aneurysm or saccular aneurysm/penetrating ulcer of the aorta in the chest or instead of another manufacturer’s endovascular stent-graft, according to the FDA. It is not to be used be in patients who have a condition that threatens to infect the graft or in patients with known sensitivities or allergies to the device materials.

Bolton Medical is based in Barcelona with U.S. operations in Sunrise, Fla.