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Enrollment begins for study evaluating branch thoracic stent graft system
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Medtronic announced that it has begun enrollment for a feasibility study assessing the safety and efficacy of a branch thoracic stent graft system.
The Valiant Mona LSA system is an investigational device intended as a fully endovascular treatment for aortic aneurysms encroaching on the left subclavian artery (LSA), according to a company press release. The trial will include 24 patients collected from up to seven facilities throughout the United States, with safety and efficacy evaluated acutely and at 30 days after implantation.
Eric Roselli
The system features a main graft to be placed in the aneurysmal segment and a branch graft to be placed in the LSA. The branch graft fits inside a tapered opening within the main graft in order to maintain LSA patency while excluding the aneurysm, according to the release.
“Thoracic aortic aneurysms involving branch vessels such as the LSA can be particularly challenging to treat,” primary investigator Eric Roselli, MD, a cardiothoracic surgeon at Cleveland Clinic, said in the release. “The use of an off-the-shelf stent graft system with a built-in branch has the potential to simplify this challenge by eliminating the routine requirement for surgical LSA bypass.”
Disclosure: Roselli serves as a consultant and receives honoraria for teaching from Medtronic.