Medtronic gains FDA approval for stent delivery system for TAA repair

9 Nov 2010

Medtronic, Inc. has received US FDA approval for its Talent Thoracic Stent Graft with Captivia Delivery System, which features a tip capture mechanism for controlled deployment and precise placement of the implantable medical device.

The Talent Captivia System is used in the endovascular repair of thoracic aortic aneurysms (TAA), dangerous bulges in the body’s main artery (near the heart) that can rupture with fatal consequences if left untreated. While an estimated 60,000 people in the United States have a TAA, only about half are ever diagnosed due to lack of symptoms.

During thoracic endovascular aortic repair (TEVAR), the Talent Captivia System is inserted into the femoral artery in the patient’s groin and moved up through blood vessels to the aorta. With the device at the site of the aneurysm, the physician expands the stent graft within the aorta, creating a new path for blood flow that reduces pressure on the bulge and the risk of rupture.

“The Captivia Delivery System’s tip capture mechanism is designed to provide excellent control of the stent graft during deployment to ensure that blood flow isn’t occluded into the nearby arteries,” said Dr Edward Y Woo, MD, vice-chief and program director of vascular surgery and endovascular therapy for the University of Pennsylvania Hospital System. “This improvement to the delivery system also increases my confidence in the device’s deployment accuracy.”

Medtronic now offers the Talent Thoracic Stent Graft in longer lengths (up to 215 mm in total length) to accommodate the aortic anatomies of more patients. In addition to tip capture, the Captivia Delivery System features a hydrophilic coating to ease insertion into the femoral artery and navigation through the iliac arteries (around the pelvis) en route to the aorta.

“In partnership with physicians around the world, Medtronic stent grafts have been used to treat more than 180,000 patients with aortic disease or injury – more than all other manufacturers combined,” said Tony Semedo, vice president and general manager of Medtronic’s Endovascular Innovations business. “FDA approval of the Talent Captivia System builds on this legacy of leadership in the field of endovascular aortic repair.”

The Talent Captivia System is indicated specifically for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy.