Reverse Medical Corporation Announces FDA 510k Clearance of the MVP-5 Micro Vascular Plug for Peripheral Embolization

December 10, 2013 06:15 AM Eastern Standard Time
IRVINE, Calif.--(BUSINESS WIRE)--Reverse Medical Corporation today announced FDA clearance for US commercialization of their MVP-5 Micro Vascular Plug system for peripheral vessel embolization, and the first US clinical case. The MVP-5 system is indicated for use to obstruct or reduce the rate of blood flow in the peripheral vasculature, in vessels measuring between 3.0 mm and 5.0 mm.

“Our first procedure with the MVP-5 was impressive, and consistent with our prior experience with the MVP-3, resulting in accurate and immediate vessel occlusion upon deployment. The device tracked easily through tortuous anatomy, allowing for more precise control than conventional embolization coils. The MVP product line has become an essential device in my lab. I’m particularly excited for its utilization in my growing Interventional Oncology practice,” stated Rahul Patel, MD, Assistant Professor, Interventional Radiology, Mount Sinai Hospital, New York, NY.

Reverse Medical Vice President Global Sales Alex Thomson commented, “The MVP-5 Micro Vascular Plug system represents an important addition to the MVP product line worldwide, soon to be followed by an MVP-7 and MVP-9, addressing a broad spectrum of peripheral vascular anatomy. Physician enthusiasm from MVP-3 clinical use created strong demand for larger sizes, and we quickly responded. Embolization coils have been known to be the favored device for vessel occlusion, largely because of no available alternative technology. The MVP has changed this paradigm by consistently demonstrating clinical, safety and economic superiority. The MVP is a platform technology with broad clinical utility for peripheral and eventual additional indications throughout the body.”