The US Food and Drug Administration (FDA) has given approval to Bolton Medical for its Relay Thoracic Stent-Graft with Plus Delivery System which is designed to be used in the treatment of thoracic aortic aneurysms and penetrating atherosclerotic ulcers.
The FDA’s approval was supported by a US pivotal study including 120 endovascular patients at 30 hospitals across the country. According to Bolton Medical, more than 7,000 Relay and Relay NBS Thoracic Stent-Grafts have been implanted worldwide.
“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,” said national principal investigator, Mark Farber, associate professor of Surgery and Radiology, director, UNC Aortic Center.
The Relay system provides varying levels of radial support and apposition, a four-step dual sheath delivery system and is available in lengths of 100mm-250mm, diameters of 22-46mm, straight and tapered.