Reverse Medical Corp.’s Micro Vascular Plug for Peripheral Embolization Gains FDA 510k Clearance; First U.S. Clinical Cases Announced
Reverse Medical Corp. officials announced FDA clearance for U.S. commercialization of the MVP Micro Vascular Plug system for peripheral artery embolization, and the first U.S. clinical cases. The MVP system indication for use is to obstruct or reduce the rate of blood flow in the peripheral vasculature.
“Our first case with the MVP-3 was impressive, and resulted in immediate vessel occlusion, which decreased procedure time. The device tracked easily through tortuous anatomy and was successfully retracted and recaptured prior to final deployment, allowing for more precise control than conventional coils,” states Ripal Gandhi, MD, Miami Baptist Cardiac and Vascular Institute.
James Benenati, MD, Medical Director, Miami Baptist Cardiac and Vascular Institute, adds, “The Microcatheter deliverability of the MVP and the opportunity to quickly occlude a vessel with one device positions the MVP as an important addition to our embolic armamentarium.”
Reverse Medical President and CEO Jeffrey Valko comments, “The MVP system represents a platform technology with broad clinical utility for Peripheral and eventual Neurovascular indications. I’m very enthusiastic about our timing with this technology, as the Embolization market is poised for dramatic growth. We forecast more than 75,000 annual procedures in the US alone. Additionally, following European CE-Mark approval, we have completed the MVP system clinical evaluation study with profound clinical success and are beginning commercialization.”