FDA Clears MVP Micro Vascular Plug
Reverse Medical Corporation Announces FDA 510k Clearance of the MVP™ Micro Vascular Plug for Peripheral Embolization™
IRVINE, Calif.--(BUSINESS WIRE)--Reverse Medical Corporation today announced FDA clearance for US commercialization of their MVP™ Micro Vascular Plug system for peripheral artery embolization, and the first US clinical cases. The MVP system indication for use is to obstruct or reduce the rate of blood flow in the peripheral vasculature.
“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.”
“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, MD, Miami Baptist Cardiac and Vascular Institute.
James Benenati, MD, Medical Director, Miami Baptist Cardiac and Vascular Institute, 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.”
Reverse Medical President and CEO Jeffrey Valko commented, “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.”
Reverse Medical Corporation is a privately held medical device company focused on expanding a technology driven pipeline of innovative, state-of-the-art endovascular treatments for a broad spectrum of peripheral and neurovascular disorders and diseases. The company is based in Irvine, California.
Reverse Medical Corporation
Jeffrey Valko, President & CEO
949-215-0660, ext. 200
Posted: August 2013