June 12, 2007 — Dr. Ronald M. Fairman, principal investigator for the VALOR clinical study evaluating the Talent Thoracic Stent Graft System, today presented positive 12-month results at a late-breaking session during the annual meeting of the Society for Vascular Surgery in Baltimore.
Sponsored by Medtronic, VALOR is a prospective, multi-center study of 195 test group patients with thoracic aortic aneurysms who were considered candidates for open surgical repair. The primary endpoint is "all cause" mortality at 12 months, comparing minimally invasive endovascular stent graft treatment to a historical surgical control group.
Dr. Fairman reported that patients in the test group who received the Talent Thoracic Stent Graft had a statistically significant reduction in all-cause mortality 16.1% compared to the surgical control rate of 29.8% (p= less than0.001) - using literature-derived figures for the open surgery group. Aneurysm-related mortality in the VALOR trial was 3.1% at 12 months. The Talent Thoracic system also had a successful aneurysm treatment rate of 89.2%. This was defined as no aneurysm growth greater than 5 mm between 1 and 12 months and the absence of a Type I endoleak.
In addition, the Talent Thoracic Stent Graft system demonstrated 100% patency, which is a measure of the graft's ability to resist collapse and remain open for proper blood flow, and there was a 99.5% success rate in deploying the stent graft. Also, the stent graft system used in the study was available in diameters ranging from 22 mm to 46 mm. Without this wide range of sizes, approximately 25% of the test arm patients in the VALOR trial would not have had the minimally-invasive stent graft therapy available to them as a treatment alternative.
Based on the VALOR data, Medtronic submitted its pre-market approval application to the U.S. Food and Drug Administration in March 2007. The device is awaiting approval. The Talent Thoracic system has been available outside the United States since 1998, with more than 20,000 implants.
For more information: www.medtronic.com