Medtronic ($MDT) gained the FDA's approval to expand the use of its Valiant Captivia thoracic stent graft system to treat patients with aortic injuries from major accidents, a bid that will help boost the company's global market share in the endovascular repair space.
"Our vision is for endovascular repair to be applicable to more patients," Tony Semedo, vice president and general manager for Medtronic's endovascular therapies business, said in a statement. "With this new indication … that vision comes into sharper focus."
Valiant Captivia first won FDA approval for the endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta, and has been marketed widely in the U.S. since May. Now, the product can also be used domestically to help stabilize bleeding from descending thoracic aortic transections, the company notes, instead of invasive surgery. These kinds of injuries can happen with trauma relating to auto accidents, major falls or other trauma that leaves a huge pressure impact on the chest, Medtronic explains.
The Valiant Captivia, constructed from specially woven fabric and sewn onto a flexible wire mesh frame, is implanted using a catheter placed into the femoral artery in the groin. A mechanism on the delivery system handle "flowers" the stent graft open, allowing blood to flow through a new path and preventing rupturing. The stent graft travels through several abdominal arteries and through the aorta to reach its targeted treatment area.
To gain the expanded indication, Medtronic relied on results from its 50-person RESCUE trial in the U.S. and Canada, which reached its primary endpoint, in part, by achieving a 30-day mortality rate of about 8%. Medtronic expects to release 6-month results this week.
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