Medtronic will begin a new feasibility study to evaluate the Valiant Mona LSA branch thoracic stent graft system’s safety and effectiveness, the Ireland-based devicemaker announced Tuesday. The endovascular device treats aortic aneurysms invading the left subclavian artery.
The study expects to enroll 24 patients across seven U.S. sites and will evaluate the device acutely and at 30 days.
The first device was successfully implanted last week. The process is simplified by eliminating the routine requirement for LSA surgical bypass using an off-the-shelf stent graft system with a built-in branch, says national primary investigator Dr. Eric Roselli.
Based on the company’s Valiant Captivia thoracic stent graft system, the device features a main graft for the aneurysmal segment aortic placement and a branch graft for LSA placement.
The Valiant Mona LSA system previously took part in an FDA medical device early feasibility pilot program in 2012. The FDA has approved the system for investigational use only. — Jason Scott