Medtronic Stent Graft for Aortic Transection Repair

New indication expands labeled uses for Valiant Captivia System in the United States


November 14, 2012

The second leading cause of traumatic death after head injuries, transection of the thoracic aorta represents a dire medical emergency in which the upper area of the body’s main artery tears due to extreme force to the chest, usually the result of motor vehicle accidents, elevated falls or other high-impact deceleration episodes. Medtronic's Valiant Captivia stent graft system, a tubular medical device consisting of a specially woven fabric sewn onto a flexible wire-mesh frame, can be used in U.S. clinical practice to stabilize bleeding from descending thoracic aortic transections as an alternative to invasive surgery.

The Valiant Captivia stent graft system has been widely available in the United States since May 2012. It was previously approved by the U.S. Food and Drug Administration (FDA) for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta, and was approved for the endovascular repair of isolated lesions (excluding dissections) of the descending segment of the thoracic aorta in November 2012. This expanded indication includes the treatment of transections.

The device is implanted in a minimally invasive procedure that uses a catheter inserted into the femoral artery, located in the groin. This technique 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, the stent graft flowers open from top to bottom, creating a new path for blood flow and reducing the risk of rupture, a complication that usually results in death.

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