Regulatory Events

Numeris® Product Line: February 2010: U.S. Investigational Device Exemption (IDE) approval for the Numeris®-AF Guided Coagulation System with VisiTrax® to evaluate the safety and efficacy of a combined epicardial and endocardial ablation procedure for the treatment of longstanding-persistent Atrial Fibrillation (AF) November 2009: U.S. Investigational Device Exemption (IDE) approval for the Numeris®-AF Guided Coagulation System with VisiTrax® to evaluate the safety and efficacy of a combined epicardial and endocardial ablation procedure for the treatment of symptomatic paroxysmal Atrial Fibrillation (AF)

• July 2009: U.S. Investigational Device Exemption (IDE) approval for the Numeris®-AF Tethered Coagulation System with VisiTrax® to enroll in a clinical trial patients undergoing concomitant, open-chest procedures under direct visualization for the treatment of longstanding-persistent Atrial Fibrillation (AF)
• February 2009: FDA marketing clearance for the Numeris® Guided Coagulation System with VisiTrax® indicated for the coagulation of cardiac tissue using radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques
• December 2008: FDA marketing clearance for the Numeris® Tethered Coagulation System with VisiTrax® indicated for the coagulation of cardiac tissue using radiofrequency (RF) energy during open-chest cardiac surgery

US only: Product indicated for coagulation of cardiac tissue