The US Food and Drug Administration (FDA) has granted approval to Medtronic to market its Valiant Captivia stent graft system for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta. This expanded indication includes the treatment of transections, commonly known as blunt traumatic aortic injuries, as an alternative to invasive surgery.
The device was previously approved by the FDA for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta.
Results from the RESCUE trial supported the new FDA indication approval for thoracic aortic transections. RESCUE enrolled 50 patients across 20 US and Canadian sites and met its primary endpoint with a 30-day all-cause mortality rate of 8.0%. Six-month results from the RESCUE trial will be presented at the upcoming VEITHsymposium (New York, USA, 14–18 November).
“This new indication of the Valiant Captivia stent graft system reduces the morbidity and mortality rates associated with surgical repair of transected aortas,” said Rodney White, chief of vascular surgery at Harbor-UCLA Medical Center, Torrance, USA and the principal investigator of the RESCUE trial. “When surgery is the only other option for repairing an aortic transection, the Valiant Captivia system can literally be a life-saver.”