Medtronic touts study data for thoracic aortic stent

Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study.

The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented at The Society of Thoracic Surgeons annual meeting in San Diego this week. It was the first five-year, industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).

BTAI is an emergency medical condition in which the aorta is damaged due to traumatic force to the chest, usually the result of elevated falls or other high-impact injuries such as motor vehicle accidents. It is the second leading cause of traumatic death after head injuries.

“These data from the Rescue trial demonstrate that TEVAR with Valiant Captivia continues to be a valuable, safe, and less-invasive alternative to open surgery for patients facing life-threatening aortic injury of BTAI, especially in the setting of critical multi-system injuries,” said Himanshu Patel, M.D., of the University of Michigan Department of Cardiac Surgery, in a prepared statement.  “This is the first five-year industry-issued dataset ever disseminated. The outcomes demonstrate Valiant Captivia to be a safe and durable therapy for high-risk BTAI patients.”

Patel presented the data at the conference. The Rescue study is a prospective, multi-center, non-randomized, descriptive study that evaluated 50 patients with BTAI of the descending thoracic aorta.  Highlights at five-year follow-up include:

• Kaplan Meier Freedom from All-Cause Mortality of 85.2%.
• No stroke or spinal cord ischemia observed.
• 100% freedom from Type I or III endoleaks.
• Kaplan-Meier Freedom from Secondary Procedures of 90.6%.
• 100% freedom from retrograde type A dissections, conversions to open repair, or aortic perforations.
• 100% complete exclusion of the traumatic injury maintained.
• No instances of stent graft kinking, fracture, loss of patency, or migration.

Subjects enrolled had a mean injury severity score of 38.4 ± 14.4 and 70% (35 of 50 subjects) whose BTAI extent was grade III or higher, including one grade IV free rupture, indicative of this extremely high-risk patient cohort. The extent of arch repair required full (40%, or 20 of 50) or partial (18%, or 9 of 50) left subclavian artery coverage. Of the 31 patients available at five years, 90.3% (28 of 31) received clinical follow-up, while 67.7%  (21 of 31) received imaging follow-up.

“The Valiant Captivia five-year transection results demonstrate our commitment to life-saving treatments and transparency in reporting long-term data to improve patient safety,” said John Farquhar, vice president and general manager of Medtronic’s aortic business. “These data also support our continuing focus on providing safe and durable endovascular repair to patients who have traditionally been challenging to treat.”

 

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