FDA clears Medtronic's thoracic stent graft

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The FDA has approved Medtronic’s Talent thoracic stent graft with Captivia delivery system, which features a tip capture mechanism for deployment and placement of the implantable medical device.

Now available for clinical practice in the U.S., the Talent Captivia System is used in the endovascular repair of thoracic aortic aneurysms (TAA). While an estimated 60,000 people in the U.S. have a TAA, only about half are ever diagnosed due to lack of symptoms. During thoracic endovascular aortic repair, the Talent Captivia system can be inserted into the femoral artery and moved up through blood vessels to the aorta, the company said. 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 Minneapolis-based 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 for insertion into the femoral artery and navigation through the iliac arteries en route to the aorta.