Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on October 26, 2011, from 8 a.m. to 6 p.m. (Day 1 of 2)

Agenda: On October 26, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. The AtriCure Synergy Ablation System consists of the following: The AtriCure Isolator Synergy Handpieces (models OLL2 and OSL2), which resemble surgical clamps, include a syringe-type grip handle/ actuator, connected by a cylindrical shaft to a pair of grasping jaws with electrodes on each jaw. The electrodes deliver radiofrequency (RF) energy to the tissue grasped by the jaws. The Ablation and Sensing Unit is an RF generator used to power the Isolator Synergy Handpieces. The Isolator Switch Matrix is an accessory interface module allowing the Isolator Synergy Handpieces to connect to the RF generator.