Oct 9 2009
Adding to its market-leading portfolio of innovative medical technology for endovascular aortic repair (EVAR), Medtronic, Inc. (NYSE: MDT), announced today the CE (Conformité Européene) mark and international launch of the Captivia Delivery System for the Valiant® Thoracic Stent Graft, a minimally invasive treatment for aneurysms and other lesions of the thoracic aorta.
The Captivia Delivery System features tip capture for enhanced control of the Valiant Thoracic Stent Graft during deployment and a hydrophilic coating applied to the graft cover to facilitate iliac access and delivery through patients’ vasculature. The new Valiant Captivia system enables physicians to treat a wide range of anatomies with a highly conformable stent graft, with accuracy and ease of delivery to achieve optimal clinical results. Both the Valiant Thoracic Stent Graft and Captivia Delivery System are investigational in the United States, where their use is limited to clinical trials approved by the U.S. Food and Drug Administration.
Prof. Giovanni Torsello, chief of vascular surgery at St. Franziskus-Hospital in Muenster, Germany, performed the first Valiant Thoracic Stent Graft implantation with the Captivia Delivery System.
“The Captivia Delivery System’s tip capture feature provides excellent control of the stent graft during deployment, which is critically important when treating lesions in the thoracic aorta,” Prof. Torsello said. “Its hydrophilic coating has also made a significant improvement in stent graft delivery. These added features will provide greater confidence in physicians’ ability to treat these very challenging cases.”
Indicated for the treatment of a variety of thoracic aortic lesions, the Valiant Thoracic Stent Graft has emerged as the minimally invasive “system of choice” for thoracic endovascular aortic repair (TEVAR) outside the United States. In four years of clinical experience, more than 15,000 patients worldwide have received the Valiant Thoracic Stent Graft.
“Given the widespread acceptance and growing use of our Valiant Thoracic Stent Graft, the Captivia Delivery System represents an enhancement that provides physicians with outstanding ease of access and delivery, as well as deployment accuracy and control,” said Tony Semedo, vice president and general manager of Endovascular Innovations, part of the CardioVascular business at Medtronic. “Combined with the Valiant Thoracic Stent Graft, which retains its hallmark attribute of conformability, the new system will expand endovascular treatment to more patients with complex aortic disease.”