Medtronic's Valiant Captivia Stent Graft Approved for Aortic Transection Repair

November 13, 2012—Medtronic, Inc. (Minneapolis, MN) announced that the US Food and Drug Administration (FDA) has approved the company's 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 (blunt traumatic aortic injuries).

According to the company, the Valiant stent graft can now be used in clinical practice in the United States to stabilize bleeding from descending thoracic aortic transections as an alternative to surgery. The device was previously approved by the FDA for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta and has been marketed for that indication in the United States since May 2012.

Medtronic advised that the new indication for thoracic aortic transections followed the FDA's review of the results of the RESCUE trial, which enrolled 50 patients across 20 sites in the United States and Canada. RESCUE met its primary endpoint with a 30-day all-cause mortality rate of 8%. The 6-month results from the RESCUE trial will be presented this week at the VEITH symposium, which is held November 14 through 18 in New York City.

Rodney White, MD, served as Principal Investigator for RESCUE and is Chief of Vascular Surgery at Harbor-UCLA Medical Center in Torrance, California. In the Medtronic press release, Dr. White commented, “This new indication of the Valiant Captivia stent graft system reduces the morbidity and mortality rates associated with surgical repair of transected aortas. When surgery is the only other option for repairing an aortic transection, the Valiant Captivia system can literally be a life-saver.”