FDA OK’s Endovascular Talent Stent for AAAs

Medtronic’s minimally-invasive Endovascular Talent™ for AAAs, first mentioned in Medgadget back in December 2007, has now been approved for marketing in the United States.

The Talent Abdominal Stent Graft System makes endovascular repair (EVAR) accessible to an additional 20 percent of AAA patients, because of its unique 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.
With a 12-year history of strong clinical performance including more than 45,000 implants worldwide, the Talent Abdominal Stent Graft is designed to offer 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 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%; SVS Control, 44.0%. 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…
In previous studies, EVAR has been shown to be an effective therapy for AAA, with fewer postoperative complications and shorter recovery times than open surgical repair. Results from a U.S. study published recently in The New England Journal of Medicine (Jan. 31, 2008), for example, indicate that perioperative mortality was significantly lower after EVAR than after open repair: 1.2 percent vs. 4.8 percent – a fourfold difference. Similarly, in a landmark study conducted in the United Kingdom and published in The Lancet (Sept. 4, 2004), the 30-day mortality rate for EVAR patients was 1.7 percent compared to 4.7 percent for patients who underwent open repair – a nearly threefold difference.

Press release: FDA Approves Medtronic’s Talent™ Abdominal Stent Graft for Repairing Aortic Aneurysms…