Reverse Medical this month won 510(k) clearance from the FDA for its MVP-5 micro vascular plug system.
The MVP-5 is indicated for the treatment of peripheral vessel embolization. The vascular plug is designed to obstruct or reduce the rate of blood flow in the peripheral vasculature, particularly in vessels measuring between 3.0 and 5.0 mm, according to a press release.
"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," global sales VP Alex Thomson said in prepared remarks. "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."
Irvine, Calif.-based Reverse recently landed CE Mark and 510(k) clearance for its ReVerse 21 and 27 neurovascular microcatheters. The regulatory nods are for use in the neurological, peripheral and coronary vasculature for the infusion of diagnostic and therapeutic agents.