FDA approves Medtronic's Captivia to deliver new Talent
This article was originally published in Clinica
Executive Summary
Medtronic's Captivia delivery system is now available in the US, after the FDA granted a premarket approval (PMA) supplement for its use with the firm's Talent thoracic stent graft. The Talent Captivia system is used to repair thoracic aortic aneurysms, bulges in the artery that can rupture if left untreated. Captivia is already available in Canada and Europe, where it is used to deliver the Valiant thoracic stent graft; however, Valiant is not yet approved in the US. The Talent stent has been available in the US since 2008 (www.clinica.co.uk, 25 April 2008), but was previously sold in smaller sizes and administered using another delivery system. Talent is now available in lengths up to 215mm.