Reverse Medical® Corporation has gained FDA 510(k) clearance to market its MVP®-5 Micro Vascular Plug system for peripheral vessel embolization, together with news of the first US clinical case.
Reverse Medical’s MVP® Micro Vascular Plug family of products are designed to occlude vessels in the peripheral vasculature quickly and predictably, with a single device. The implantable device comprises a microvascular stented occlusion device which is delivered using a microcatheter directly to distal, superselective vessels for targeted treatment. The devices are fully resheathable to facilitate accurate placement.
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 and 5.0 mm, increasing the maximum target vessel size compared with its previous iteration, the MVP-3 system.
Fine the FDA clearance here.
“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.”
Source: Reverse Medical Corporation, Business Wire