Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization.
MVP Micro Vascular Plug system is used to obstruct or reduce the rate of flow of blood in the peripheral vasculature.
The company also reported the first clinical use of MVP Micro Vascular Plug system in the US.
Miami Baptist Cardiac and Vascular Institute Dr Ripal Gandhi noted the 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," Dr Gandhi added.
Reverse Medical president and CEO Jeffrey Valko noted the MVP system represents a platform technology with broad clinical utility for peripheral and eventual neurovascular indications.
"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," Valko added.
