FDA Approves Medtronic’s Valiant Captivia Thoracic Stent Graft System for Aortic Dissections
February 3, 2014
February 3, 2014 — The U.S. Food and Drug Administration (FDA) Medtronic Inc.’s Valiant Captivia Thoracic Stent Graft System to treat type B aortic dissections.
Supported by the results of the U.S. Medtronic DISSECTION trial, the new indication provides physicians a minimally invasive alternative to open surgical repair and medical therapy.
12-month data from the 50 patients evaluated in DISSECTION demonstrate safety and efficacy of the Valiant Captivia System in the treatment of dissections, with technical success.
Conducted at 16 U.S. sites, the trial met its primary safety endpoint by achieving an 8 percent all-cause mortality rate at 30 days, which represents a three- to four-fold mortality improvement over open surgical repair. 100 percent technical success and 100 percent coverage of the primary entry tear at implant were achieved in the trial.
Indicated for a variety of thoracic aortic lesions, the Valiant Captivia System features a proximal tip-capture mechanism, enabling controlled deployment and accurate placement of the stent graft. The Valiant stent graft maintains apposition to the vessel wall regardless of angulation or oversizing. Since its initial 2005 launch in Europe, the Valiant stent graft has been implanted in about 50,000 patients worldwide.
Medtronic expanded the size matrix of the Valiant Captivia Thoracic Stent Graft System with 11 proximal FreeFlo tapered pieces. This increased configuration possibilities by 30 percent to address a wider range of patient anatomies. The line extension enables physicians to use the thoracic stent graft system in tapered aortas, which account for approximately 20 percent of all thoracic aortic aneurysm cases. The pieces all taper by 4 mm along their approximately 150 mm length, and have proximal diameters ranging 26 mm to 46 mm. These additional system components received FDA approval, CE marking and Health Canada approval in January 2013. In Europe, they are approved for use in treating thoracic aortic aneurysms, transections and dissections; in the United States, for thoracic aortic aneurysms and transections; and in Canada, for thoracic aortic aneurysms.
For more information: www.medtronic.com