Oct 22 2008
Extending an unmatched record of innovation in the field of endovascular aortic repair, Medtronic, Inc., today announced the U.S. market launch of the Talent Thoracic Stent Graft on the Xcelerant Delivery System, which makes minimally-invasive treatment of thoracic aortic aneurysms easier to perform.
A thoracic aortic aneurysm is a dangerous bulge or weakness in the main artery extending from the heart that affects nearly 10 of every 100,000 elderly people in the United States. Thoracic endovascular aortic repair (TEVAR) is a minimally invasive procedure in which a stent graft is threaded through the femoral artery and expanded at the site of the aneurysm. Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm and the risk of rupture. Left untreated, aortic aneurysms can burst, an emergency situation that commonly results in death due to extensive internal bleeding. The alternative to TEVAR is open surgical repair.
Recently approved by the FDA, the Talent Thoracic Stent Graft with the new delivery system is now available to physicians across the United States. The Talent Thoracic Stent Graft expands the applicability of TEVAR to more patients with thoracic aortic aneurysms. The unique features of the Xcelerant Delivery System and the Talent Thoracic Stent Graft provide meaningful benefits to both physician and patient: a wide range of sizes so more patients can be treated; improved trackability and controlled deployment for easier and more accurate stent graft placement; and high radial force as shown in competitive bench testing.
Dr. Karthikeshwar Kasirajan, vascular surgeon and professor at Emory University Hospital in Atlanta, is among the first U.S. physicians to have implanted a Talent Thoracic Stent Graft using the Xcelerant Delivery System. “This combination of a proven stent graft and an advanced delivery system marks a major step forward for the minimally invasive treatment of thoracic aortic aneurysms,” Dr. Kasirajan said. “The system facilitates stent graft delivery and deployment with greater ease and control, especially through narrow vessels and challenging anatomies.”
Dr. Ronald Fairman, professor and chief of the Division of Vascular Surgery and Endovascular Therapy at the Hospital of the University of Pennsylvania in Philadelphia, served as the principal investigator of the clinical study that supported FDA approval of the Talent Thoracic Stent Graft. “Given the wide diameter treatment range, 25 percent of implanted subjects in the VALOR trial could not have been treated with current commercially available devices,” he said.
“The Xcelerant Delivery System unlocks the full potential of the Talent Thoracic Stent Graft by combining unique features that are unavailable in the current alternatives,” said Tony Semedo, vice president and general manager of Endovascular Innovations, part of the CardioVascular business at Medtronic. “Medtronic’s latest innovation in aortic repair technology represents our continued commitment to leadership in this field and to ensuring that thousands more patients will benefit from minimally-invasive treatment.”
As the pioneer of endovascular therapy, Medtronic has been an innovator and leader in the aortic stent graft industry for more than a decade. Its long history includes more than 140,000 patients treated with stent grafts dating back to 1996. Medtronic currently offers the broadest portfolio of aortic stent grafts in the industry. These include the Talent Abdominal and Thoracic Stent Graft Systems worldwide; the AneuRx AAAdvantage® Abdominal Stent Graft System in the United States; and the Endurant Abdominal and Valiant® Thoracic Stent Graft Systems outside the United States.
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