The 7-patient trial, run under Investigational Device Exemption from the FDA, was designed to examine the Valiant Mona LSA in treatment of aortic aneurysms involving the left subclavian artery, which feeds part of the brain and the left arm.
The 1st look at study results showed 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, Medtronic reported.
"The initial results of this early feasibility study are extremely encouraging," said Dr. Frank Arko, one of the study’s 2 investigators. "This new technology could potentially minimize the need for invasive surgery and extend the benefits of endovascular repair without additional surgery to more patients with thoracic aortic aneurysms."
The Valiant Mona LSA was 1 of only 9 devices selected in 2012 to undergo review via 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."