FDA clears Bolton's stent graft system for TAAs

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The FDA has approved Bolton Medical's Relay thoracic stent graft with Plus delivery system to use as a minimally invasive treatment for thoracic aortic aneurysms (TAAs) and penetrating atherosclerotic ulcers.

The Relay system offers performance zones to provide varying levels of radial support and apposition; a four-step dual sheath delivery system; various sizes with lengths of 100 to 250 mm and diameters of 22 to 46 mm; and straight and tapered.

Bolton stent grafts have been available in Europe and other international markets since 2005. The U.S. pivotal study included 120 endovascular patients at 30 hospitals across the U.S.