Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on July 21, 2011, from 8 a.m. to 6 p.m (Day 2 of 2)

Agenda: On July 21, 2011, the committee will discuss, make recommendations, and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD device is a pneumatically-driven extracorporeal ventricular assist device. It is designed to provide bridge-to transplant mechanical support to the heart. The system consists of one or two extracorporeal blood pumps (univentricular or biventricular support), cannulae for the connection of the blood pumps to the atria and great arteries, and the IKUS Stationary Driving Unit (electro-pneumatic driving system).