CE Mark And Clinical Use For MVP™ Micro Vascular Plug In Peripheral Embolization

California-based Reverse Medical Corporation has announced the initial clinical use of its MVP™ Micro Vascular Plug system for peripheral artery embolization. The device has been granted CE Mark approval to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Background

The MVP™ system was introduced May 1st during the 2013 Global Embolization Symposium and Technologies (GEST 2013 – Europe) conference in Prague, Czech Republic, by GEST co-chairman Jafar Golzarian, MD (U. Minnesota, Minneapolis, MN). The clinical cases presented were performed by GEST co-chairman Marc Sapoval, MD PhD and Olivier Pellerin, MD MSc (Hôpital Européen Georges-Pompidou, Paris, France), and Geert Maleux, MD PhD (U. Hospital, Leuven, Belgium).

Physician comments

Commenting on their MVP system experiences, Drs. Sapoval and Pellerin agreed “the MVP represents a unique advancement for the Interventional Radiologist as being microcatheter deliverable to select distal targets in tortuous anatomy, and is completely re-sheathable for re-positioning if needed, or for procedures where temporary occlusion or flow reduction might be necessary.” Dr. Maleux added, “In addition to the breakthrough deliverability and re-sheathability, the device demonstrated consistent evidence of immediate vessel occlusion.” Dr. Golzarian concluded, “The MVP system is a game-changer, has multiple clinical applications for embolization procedures, and based on evidence of immediate occlusion from a single implant, it is cost efficient.”

Company comments

Reverse Medical President & CEO Jeffrey Valko, commented, “Our team continues to innovate at a rapid pace with an expanding range of novel endovascular products. The MVP system represents a platform technology with 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’ve recently hired a Business Development Director, based in Paris, and we will begin commercialization throughout Europe early third quarter.”