Reverse Medical Corporation has gained FDA clearance for US commercialization of its MVP™ Micro Vascular Plug system for peripheral artery embolization, and the first US clinical cases.
We first covered endovascular device company, Reverse Medical Coropration’s MVP device back in June of this year, with the announcement that it had gained CE mark approval and seen first clinical use in Europe.
As with the CE mark indication, the FDA clearance allows MVP to be used 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, 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.”
Source: Reverse Medical Corporation, Business Wire