Simply stated, VisiTrax® applies radiofrequency (RF) energy to the outer surface of the heart to create lesions. Several things make us unique in how we do this:
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
