Medtronic (NYSE:MDT) said today that it launched a new feasibility study of its Valiant Mona LSA stent graft in treating aortic aneurysms affecting the left subclavian artery.
Fridley, Minn.-based Medtronic said the 24-patient study is designed to evaluate the safety & effectiveness of the Valiant Mona LSA device acutely and at 30 days. About 40% of AA cases treated endovascularly need LSA coverage, according to the company, and Society for Vascular Surgery guidelines recommend LSA revascularization in some cases.
Lead investigator Dr. Eric Roselli of the Cleveland Clinic said aneurysms involving branch vessels like the LSA can be particularly challenging.
"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," Roselli said in prepared remarks. Medtronic said it pays consulting fees and teaching honoraria to Roselli.
The Valiant Mona LSA system consists of a main graft for the aorta and a branch graft for the LSA, which fit together when deployed to cover the aneurysm while keeping the LSA open, Medtronic said.
"The start of this study represents another step forward in our efforts to develop standardized stent graft systems for the treatment of aortic disease involving branch vessels," Medtronic vice president Daveen Chopra said in prepared remarks. "We remain committed to innovating safe and effective endovascular solutions for these complex clinical challenges in support of vascular interventionalists and their patients around the world."
In November 2013, Medtronic released data from a 7-patient pilot study of Valiant Mona LSA showing 100% technical success in placing the devices and 100% patency in both the main and branch grafts, with no reported type I or III leaks. The device was 1 of only 9 selected in 2012 for the FDA’s Innovation Pathway, designed to "reduce the overall time and cost it takes for the development, assessment, and review of safe and effective medical devices that address unmet medical needs, so these devices can get to the patients who need them sooner without jeopardizing patient safety."
