First Patient Treated With Valiant Thoracic Stent Graft in RESCUE Study
May 19, 2010—Medtronic, Inc. (Minneapolis, MN) announced that the first patient has been enrolled in its RESCUE clinical trial. The RESCUE trial will evaluate the safety and effectiveness of the Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of patients with blunt thoracic aortic injuries (BTAI).
Medtronic initiated the RESCUE clinical trial in March 2010 and expects to enroll a total of 50 patients at up to 25 sites in the United States. Anthony Murphy, MD, and Joshua Rovin, MD, collaborated on the first Valiant Captivia implant in RESCUE. They successfully treated a 21-year-old patient with a BTAI resulting from a motor vehicle accident.
“Many patients with BTAI never make it to the emergency room,” commented Dr. Rovin, “Those who do typically arrive with tears of the aortic wall and internal bleeding that require surgery to repair. But for some patients, due to other circumstances of their injury, surgery is too risky to attempt.”
Dr. Murphy added, “This trial will help to determine if Valiant Captivia is effective for patients with BTAI. If the technology works in demanding clinical situations such as total aortic transection, it may have positive implications for the treatment of other aortic injuries.”
Both the Valiant thoracic stent graft and Captivia delivery system are investigational devices in the United States, Medtronic advised.