Medtronic's Valiant Studies Complete Enrollment

October 7, 2009—Medtronic, Inc. (Minneapolis, MN) announced the completion of enrollment in two clinical trials studying the use of the company's Valiant thoracic stent graft system for treating descending thoracic aortic aneurysms (TAAs) and descending thoracic aortic dissections, respectively. The Valiant device is Medtronic's next-generation thoracic endograft, which is designed for minimally invasive treatment of thoracic aortic diseases.

According to the company, the VALOR II clinical trial enrolled 160 patients at 27 investigational sites in the United States. The trial will examine the safety and efficacy of Valiant in treating descending TAAs. The data from this trial will be used to support an application to the US Food and Drug Administration for product approval in the United States.

Additionally, Medtronic stated that the VIRTUE registry enrolled 100 patients at 14 clinical centers in Western Europe. VIRTUE will evaluate the use of the Valiant graft for treatment of descending thoracic aortic (or type B) dissections. The device has been available outside the United States since 2005 for the treatment of TAAs, dissections, and other lesions. The objective of the VIRTUE registry is to collect additional health economics and clinical performance data on Valiant for the treatment of acute dissections, complicated or expanding subacute dissections, and expanding chronic dissections.

The company also announced the European launch of its Captivia delivery system for the Valiant thoracic stent graft. Captivia features tip capture for enhanced control during stent graft deployment and a hydrophilic coating that is applied to the graft cover to facilitate iliac access and stent graft delivery. These features will allow the treatment of a wide range of anatomies with a highly conformable stent graft, the company stated.

"The Captivia delivery system's tip capture feature provides excellent control of the stent graft during deployment, which is critically important when treating lesions in the thoracic aorta," commented Professor Giovanni Torsello, MD, who performed the first Valiant thoracic stent graft implantation with the Captivia delivery system. "Its hydrophilic coating has also made a significant improvement in stent graft delivery. These added features will provide greater confidence in physicians' ability to treat these very challenging cases."