The US Food and Drug Administration (FDA) has approved the use of Bolton Medical's Relay Thoracic Stent-Graft with Plus Delivery system in treating thoracic aortic aneurysm and penetrating atherosclerotic ulcers.
The minimally-invasive device, which is available in lengths of 100mm-250mm and diameters of 22-46mm, features four-step dual sheath delivery system and distinct performance zones which provide varying levels of radial support and apposition.
The approval was accorded based on the pivotal study which included 120 endovascular patients at 30 hospitals across the country.
UNC Aortic Center vascular surgery program director, surgery and radiology associate professor and national principal investigator Mark Farber said 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," Farber added.