FDA expands indication for Medtronic's stent graft

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The FDA has approved Medtronic'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, or blunt traumatic aortic injuries, according to the company. 

The Valiant stent graft, a tubular medical device consisting of a woven fabric sewn onto a flexible wire-mesh frame, can now be used in U.S. clinical practice to stabilize bleeding from descending thoracic aortic transections as an alternative to invasive surgery. Previously approved by the FDA for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta, the Valiant Captivia stent graft system has been available since May in the U.S.

The device is implanted in a minimally invasive procedure that uses a catheter inserted into the femoral artery, which requires only a small incision to access the aorta as opposed to larger incisions required for open surgery. Compressed inside the delivery system, the device passes through several arteries in the abdomen and up the aorta to the location of the damaged area. By turning a mechanism on the handle of the delivery system, Medtronic said, the stent graft opens from top to bottom, creating a new path for blood flow.

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 U.S. and Canadian sites. Six-month results from the RESCUE trial will be presented at the VEITHsymposium in New York City, Nov. 14-18.