An innovative medical device used in the minimally invasive treatment of thoracic aortic aneurysms, the Valiant® Thoracic Stent Graft System from Medtronic, Inc. (NYSE: MDT), delivered excellent clinical results through one year of patient follow-up in the company's U.S. pivotal study, VALOR II, according to data presented today at a meeting for vascular surgeons.
A thoracic aortic aneurysm (TAA) is a dangerous bulge in the body's main artery near where it branches off the heart; those that rupture usually result in death. An estimated 60,000 people in the United States alone have a TAA. Those that are detected before rupturing can usually be effectively treated with stent grafts or invasive surgery.
One-year results of the VALOR II study were presented today during a late-breaking clinical trials session at the annual meeting of the Society for Vascular Surgery by principal investigator Dr. Ronald Fairman, M.D., the Clyde F. Barker - William Maul Measey Professor of Surgery at the Hospital of the University of Pennsylvania, where he is chief of the division of vascular surgery and endovascular therapy, and the department of surgery's vice-chairman of clinical affairs. Attended by more than 1,500 vascular surgeons, the three-day 2011 Vascular Annual Meeting in Chicago ends today.
"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," Dr. Fairman concluded. "Through 12 months, there were no cases of rupture or conversion to open surgery. Overall, treatment results were quite promising."
VALOR II is a prospective, single-arm study that involved 160 patients at 24 U.S. medical centers. It was designed to evaluate the safety and effectiveness of the Valiant Thoracic Stent Graft System for thoracic endovascular aortic repair (TEVAR) of aneurysms in the descending thoracic aorta.
The study met all of its prespecified endpoints. The primary safety and effectiveness endpoints were 12-month all-cause mortality and 12-month successful aneurysm treatment, defined as the absence of (a) aneurysm growth (>5 mm) at one and 12 months, and (b) type I and/or type III endoleak for which a secondary procedure was performed or recommended at or before the 12-month visit.
Through one-year of follow up in VALOR II, the rate of all-cause mortality was 12.6 percent, with only 3.3 percent of mortalities deemed aneurysm-related. Nearly all patients (97.4%) achieved 12-month successful aneurysm treatment, and very few stent grafts (2.9%) migrated from their original placement.