Overview of the 2013 Food and Drug Administration Circulatory System Devices Panel Meeting on the MitraClip Delivery System

Abstract

The MitraClip system (MCS; Abbott Vascular, Santa Clara, CA) is a percutaneously delivered device aimed at reducing severe mitral valve regurgitation (MR) by approximating the mitral valve leaflets. The device is introduced through the femoral vein and advanced into the left atrium through a transseptal puncture. With echocardiographic guidance, the MitraClip is permanently placed in a fashion that approximates the anterior and posterior leaflets as seen in the surgical technique by Alfieri and De Bonis,1 although it should be noted that this technique includes mitral annuloplasty as an essential component. After being in development for more than a decade, the MCS was approved for commercial use in Europe in 20082 and is recommended by the European Society of Cardiology for use in patients with symptomatic severe MR who are determined to be inoperable or at high surgical risk by a heart team and who have a life expectancy >1 year (recommendation Class IIb , Level of Evidence C ).3 The MitraClip is currently approved for use in >40 countries with >8000 patients having been treated with this device, most of whom are at high surgical risk.2 On March 20, 2013, the Food and Drug Administration’s (FDA’s) Circulatory System Devices Panel met to discuss the premarket approval (PMA) application for the MCS. The scientific data presented to support the PMA were based on the pivotal randomized, controlled Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II trial,4 along with data from 2 registries: 1 derived from a subgroup analysis of the EVEREST II data and 1 derived from continued-access registries. The first US MCS clinical trial, EVEREST I, was a single-arm feasibility registry of 55 patients. This trial completed its 5-year follow-up with reassuring results. The pivotal EVEREST II trial, initiated in August 2005, was a randomized, controlled …