FDA Approves Reverse Medical’s Micro Vascular Plug

Reverse Medical Corporation has received U.S. Food and Drug Administration 510(k) clearance to commercialize its MVP Micro Vascular Plug system for peripheral artery embolization. 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,” stated Ripal Gandhi, M.D., of the Miami Baptist Cardiac and Vascular Institute in Miami, Fla.

James Benenati, M.D., medical director at Miami Baptist, added, “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.”

The plug helps decrease blood flow in the peripheral vasculature and is “completely re-sheathable” for use in procedures where a patient needs only temporary blood flow reduction. The FDA’s approval occurs just three months after the company received European regulators’ blessing and began treating the first patients there.

“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 U.S. alone. Additionally, following European CE-Mark approval, we have completed the MVP system clinical evaluation study with profound clinical success and are beginning commercialization,” Reverse Medical President and CEO Jeffrey Valko said.

Reverse Medical Corporation is a privately held medical device company focused on expanding a technology driven pipeline of  endovascular treatments for a broad spectrum of peripheral and neurovascular disorders and diseases. The company is based in Irvine, California.