One-Year VALOR II Data Presented for Medtronic's Valiant TEVAR System

June 18, 2011—Medtronic, Inc. (Minneapolis. MN) announced that 1-year follow-up clinical results from the VALOR II pivotal study of the company's Valiant thoracic stent graft system were presented at the Society for Vascular Surgery's 2011 Vascular Annual Meeting in Chicago. VALOR II Principal Investigator Ronald Fairman, MD, presented the data, which showed that the study met all of its prespecified endpoints.

The prospective, single-arm VALOR II study is designed to evaluate the safety and effectiveness of the Valiant device for the endovascular repair of descending thoracic aortic aneurysms (TAAs). The study involved 160 patients at 24 medical centers in the United States.

“The VALOR II 12-month results demonstrate that the Medtronic Valiant stent graft is a safe and effective treatment for patients with descending TAA of degenerative etiology," concluded Dr. Fairman. "Through 12 months, there were no cases of rupture or conversion to open surgery. Overall, treatment results were quite promising."

According to Medtronic, the primary safety and effectiveness endpoints were 12-month all-cause mortality and 12-month successful aneurysm treatment. Successful treatment was defined as the absence of aneurysm growth (> 5 mm) at 1 and 12 months, and type I and/or type III endoleak for which a secondary procedure was performed or recommended at or before the 12-month visit. Through 1 year of follow-up in VALOR II, the rate of all-cause mortality was 12.6%, with a 3.3% rate of aneurysm-related mortalities. Approximately all patients (97.4%) achieved 12-month successful aneurysm treatment, and very few stent grafts (2.9%) migrated from their original placement.

Medtronic advised that the Valiant thoracic stent graft system is indicated for the endovascular repair of fusiform aneurysms, saccular aneurysms, and penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm; and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm.