Medtronic to Launch Valiant Captivia Thoracic Stent Graft in United States, Japan, and China

May 8, 2012—Medtronic, Inc. (Minneapolis, MN) announced that it is expanding availability of the Valiant Captivia thoracic stent graft system in several countries, including China, Japan, and the United States.

The Valiant Captivia stent graft is approved by the US Food and Drug Administration (FDA) for endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta in patients with a nonaneurysmal aortic diameter in the range of 18 to 42 mm and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm. The device's approved indications in China and Japan are similar.

According to Medtronic, the Valiant Captivia stent graft system updates earlier generation devices by featuring an eight-peak crown that secures the deployed device inside the aorta. The device's design provides more flexibility and conformability by eliminating a longitudinal connecting bar.

In related news, Medtronic announced the completion of enrollment in the RESCUE trial, an investigational clinical study of the Valiant Captivia system as an endovascular treatment for blunt thoracic aortic injuries. Data from RESCUE will be used to seek an expanded indication for the device to treat aortic transections. Rodney A. White, MD, is the study's Principal Investigator.

In RESCUE, 50 patients were enrolled at 20 sites in the United States to investigate the safety and effectiveness of stent grafts for the treatment of blunt thoracic aortic injuries. Early results on the first 33 patients enrolled in the study showed that all-cause mortality at 30 days, which is the study's primary endpoint, was 12% for this patient group. Alan Matsumoto, MD, presented the data in March at the 38th annual scientific meeting of the Society of Interventional Radiology in San Francisco.

“Traditionally, the mortality rates associated with surgical repair of blunt thoracic aortic injuries range from 15% to 20%. With this frame of reference, the early data from RESCUE is very encouraging,” Dr. Matsumoto commented in a press release. “We look forward to reporting the final results on all 50 patients in the study at a major upcoming scientific medical meeting.”