Medtronic Presents 30-Day VALOR II Data for Valiant TEVAR Device

November 19, 2010—At the VEITH Symposium in New York City, Medtronic, Inc. (Minneapolis, MN) announced 30-day follow-up data from the United States pivotal trial for the company's Valiant thoracic stent graft system.

According to Medtronic, the prospective, single-arm VALOR II study involved 160 patients at 24 medical centers in the United States. The study was designed to evaluate the safety and effectiveness of using the Valiant device for thoracic endovascular aortic repair (TEVAR) of aneurysms in the descending thoracic aorta. The study was conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE).

Through 30 days of follow-up in VALOR II, the company reported rates of 0.7% for type I endoleaks, 3.4% for type II endoleaks, and 0.0% for both type III and IV endoleaks. In addition, no patient treatment plans were converted from TEVAR to open surgery, and no patients experienced aneurysm rupture. The rate of all-cause mortality through 30 days was 3.1%.

“These compelling interim data from VALOR II show great promise for the Valiant thoracic stent graft,” commented principal investigator Ronald Fairman, MD. “We look forward to seeing whether these results persist at the primary endpoint of 12 months and supply the evidence needed so that clinicians in the United States can use the Valiant stent graft in their practice.”

The study's primary safety and effectiveness endpoints are 12-month all-cause mortality and 12-month successful aneurysm treatment, which is 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. The 1-year results of VALOR II will be presented in mid-2011, along with 5-year TEVAR data from VALOR, the FDA-approved IDE study of Medtronic's Talent thoracic stent graft.

The Valiant thoracic stent graft system received the CE Mark approval in October 2009. In the United States, it is an IDE that is limited to use in FDA-approved clinical studies. VALOR II data will be used in Medtronic's submission to the FDA for premarket approval of the Valiant device, the company stated.