Extending the availability of its endovascular innovations into another major world market, Medtronic, Inc. announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Talent? Thoracic Stent Graft, a lifesaving technology that allows more patients to benefit from a minimally-invasive treatment for certain types of aneurysms of the descending thoracic aorta.
At the same time, the MHLW granted approval for the Reliant® Stent Graft Balloon Catheter, which is used in abdominal and thoracic endovascular procedures to facilitate endograft modeling and fixation to the vessel wall.
Medtronic plans to launch the Talent Thoracic Stent Graft and the Reliant Stent Graft Balloon Catheter in Japan after reimbursement approval.
An aortic aneurysm is a dangerous bulge or weakness in the main artery extending from the heart. Left untreated, aortic aneurysms can burst, an emergency situation that commonly results in death due to extensive internal bleeding. Thoracic endovascular aortic repair (TEVAR) is a minimally invasive procedure in which a stent graft ? a fabric tube reinforced with a metal springs ? 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. The alternative to TEVAR is open surgical repair.
?We look forward to collaborating with physicians in Japan so more patients with aortic aneurysms can avoid open surgical repair, and benefit from our innovative stent graft systems,? said Tony Semedo, vice president of the CardioVascular business and general manager of the Endovascular Innovations division at Medtronic. ?Japan is a high-priority market for Medtronic. Pending the requisite regulatory and reimbursement approvals, in the years ahead, we intend to follow the Talent Thoracic Stent Graft with many other aortic repair technologies from our extensive portfolio and pipeline to extend the option of minimally-invasive treatment to even more patients.?
With more than 10 years of clinical use worldwide, the Talent Thoracic Stent Graft has been implanted in more than 20,000 patients. Approved by the FDA in June 2008, it expands the applicability of TEVAR to more patients. The unique features of the Talent Thoracic Stent Graft with the CoilTrac Delivery System include a broad range of diameters to treat a variety of anatomies, a low profile to ease insertion and navigation, and high overall radial force for secure fixation. The size matrix spans more diameters (from 22 mm to 46 mm) than any other commercially available thoracic stent graft in Japan.
The safety and efficacy of the Talent Thoracic Stent Graft have been well characterized. In the VALOR clinical trial, the 30-day mortality was 2.1 percent and aneurysm-related mortality at 12 months was 3.1 percent, showing that treatment with the Talent Thoracic Stent Graft results in lower mortality than open surgery, as well as low rates of morbidity and device-related adverse events. The CoilTrac Delivery System demonstrated 99.5 percent technical success in its simple, ?one-step,? pull mechanism and low-profile design.
A pioneer of endovascular aortic repair, Medtronic has been an innovator and leader in the stent graft industry since the 1990s. Its history includes more than 150,000 patients treated with stent grafts. Medtronic offers the broadest portfolio of aortic stent grafts. The AneuRx AAAdvantage® and Talent Abdominal Stent Grafts with the Xcelerant® Hydro Delivery System and the Talent Thoracic Stent Graft with the Xcelerant Delivery System are commercially available in the United States. The Valiant® Thoracic Stent Graft and the Endurant® Stent Graft Systems are commercially available only outside the United States and are currently under clinical investigation in the United States.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology ? alleviating pain, restoring health and extending life for millions of people around the world.