Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
[Committee Meeting April 26th from 8:00 a.m. to 6:00 p.m. (Day 2 of 2)

Agenda: On April 26, 2012, the committee will discuss, make recommendations and vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System sponsored by Cameron Health, Inc. The S-ICD is the first implantable defibrillator that does not require the implantation of an electrode either on or in the heart. The S-ICD is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias. The device is capable of delivering high energy defibrillation shocks as well as bradycardia demand mode cardiac pacing. The study provides data from the treatment of induced acute and chronic episodes of ventricular tachycardia/ventricular fibrillation and spontaneous episodes. In addition to the investigational device exemption study, clinical data were also obtained from using studies outside the United States and registries.