Five-Year Data Presented for Medtronic's AAA Talent at SVS Annual Meeting
June 15, 2009—Medtronic, Inc. (Minneapolis, MN) announced that 5-year results from the study of the company's Talent abdominal stent graft for the endovascular treatment of abdominal aortic aneurysms (AAAs) were presented by Luis Sanchez, MD, at the Society for Vascular Surgery's 2009 Vascular Annual Meeting in Denver, Colorado. Frank Criado, MD, is the study's principal investigator. These data constitute the final results of the study, which involved 166 patients enrolled between February 2002 and April 2003 at 13 clinical research sites in the United States. Earlier data from the study contributed to the original US Food and Drug Administration approval for the device in April 2008.
According to the company, the device demonstrated durable safety and effectiveness even in AAA patients with challenging anatomies. The study enrolled a significant number of patients with challenging AAA morphology who would have been excluded from investigational device exemption trials of other stent graft products because of stricter inclusion criteria and limited device size offerings in those trials.
The study's primary safety endpoint compared a composite of major adverse events (MAE) to a historical control of 243 patients who underwent conventional open surgical AAA repair. Freedom from MAE at 30 days was 89.2% in the Talent AAA group and 44% in the open surgical repair group. The effectiveness endpoint assessed successful aneurysm treatment, defined as technical success with device placement, as well as freedom from aneurysm growth > 5 mm and freedom from type I or III endoleak at 1 year. Successful aneurysm treatment at 12 months was obtained in 90.2% of the Talent AAA study population. The 5-year outcomes also included a 96.5% freedom from aneurysm-related death, 98.2% freedom from AAA rupture, 99.1% freedom from conversion to open repair, and 97.7% freedom from migration, the company stated.
"In a population with more challenging anatomical characteristics than in other clinical trials of similar technologies for endovascular repair of AAAs, the Talent stent graft system compared favorably with open repair through 1 year," commented Dr. Sanchez. "More importantly, the Medtronic device also provided sustained protection from aneurysm-related mortality through 5 years, with minimal reinterventions."