FDA Clears Medtronic's Talent Abdominal Stent Graft for AAA
April 17, 2008 - Medtronic Inc. received clearance from the FDA for use of the Talent Abdominal Stent Graft on the CoilTrac Delivery System, a medical device that expands patient access to a minimally-invasive treatment option for abdominal aortic aneurysms.
The Talent Abdominal System aims to offer AAA patients minimally-invasive repair as an alternative to open surgical repair. The Talent Abdominal Stent Graft System makes endovascular repair (EVAR) accessible to reportedly an additional 20 percent of AAA patients because of its proximal aortic neck length requirement of only 10 mm. Consisting of a woven polyester membrane supported by a tubular metal lattice, the device is specifically indicated for endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. The stent graft is available in diameters of up to 36 mm, as well as flared and tapered iliac limbs of 8 mm to 24 mm.
The Talent Abdominal Stent Graft is designed to provide broad patient applicability, suprarenal fixation and positioning accuracy. The stent graft features radiopaque markers for visual guidance during deployment and follow up, and the delivery system uses a single-step release mechanism for smooth deployment and a coiled rod for enhanced trackability and flexibility.
"The Talent Abdominal Stent Graft has provided excellent patient outcomes in clinical practice and in clinical study," said Dr. Michael L. Marin, professor of Vascular Surgery and chairman of the Department of Surgery at The Mount Sinai Medical Center in New York. "In my own experience, with more than 750 successful implants using the Talent System, the performance of this stent graft has been very consistent, and its safety and efficacy have been well characterized through the results of our own clinical trial."
The Medtronic-sponsored clinical study of the Talent Abdominal Stent Graft System enrolled 166 patients at 13 medical centers between February 2002 and April 2003. All 166 patients received a Talent Abdominal Stent Graft; their outcomes were compared to those of 243 patients from the Society of Vascular Surgery (SVS) Surgical Control Group at 30 days and one year post-implant. Dr. Frank Criado, director of Union Memorial Hospital's Endovascular Program in Baltimore, was the principal investigator for the study.
The study demonstrated that the Talent Abdominal Stent Graft well exceeded the SVS Control in freedom from major adverse events at 30 days, with a statistically significant difference between the two groups: Talent, 89.2 percent; SVS Control, 44.0 percent. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, at 30 days post-implant they experienced lower rates of major adverse events compared with subjects treated with open surgery. Importantly, there were no aneurysm ruptures and no conversions to open surgery in the Talent group up to 12 months after device implantation.
For more information: www.medtronic.com
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