Medtronic's Valiant Captivia thoracic stent graft system is now approved for type B aortic dissections, a deadly tear in the aorta, the body's main artery.
|The Valiant Captivia stent graft system--Courtesy of Medtronic|
With this FDA win, Medtronic ($MDT) follows its Flagstaff, AZ-based competitor, W.L. Gore, in stent grafts--a larger, fabric-covered type of stent used to repair blood vessels. In September, Gore won a similar broadened indication for its own stent graft system, the TAG thoracic endoprosthesis. At the time, TAG was the only device to win FDA backing for use in aneurysm, trauma and dissection.
Medtronic's Tuesday announcement followed investigators' presentation of 12-month data from 50 patients this week at the Society for Thoracic Surgeons annual meeting in Orlando, FL. The data showed 100% technical success and an 8% all-cause mortality rate at 30 days in treating dissections, the company announced. According to Medtronic's release, it was a three- to fourfold mortality improvement over open surgical repair.
Valiant Captivia is now approved to treat aneurysms, penetrating ulcers and--since November, 2012--aortic injuries from major accidents.
Type B dissections are not as frequently treated with surgery as the type A category. Medtronic says its data on Valiant Captivia are part of a growing body of evidence that thoracic endovascular aortic repair (TEVAR) operations are effective in the treatment of type B aortic dissections.
"Acute type B aortic dissection is a potentially life-threatening condition that historically has been treated with either medical therapy or, when necessary, through invasive surgical techniques," trial investigator Dr. Joseph Bavaria of the University of Pennsylvania in Philadelphia said in a prepared statement. "The trial we conducted shows that endovascular repair with the Valiant Captivia System provides a safe, effective and potentially life-saving treatment option for acute dissection patients."
- read Medtronic's press release
- get more at angioplasty.org