FDAnews
www.fdanews.com/articles/67893-medicalcv-completes-first-u-s-case-using-atrilaze

MedicalCV Completes First U.S. Case Using AtriLaze

January 24, 2005

MedicalCV has completed the first U.S. human clinical case using the AtriLaze Surgical Ablation System, the company said.

Cardiothoracic and vascular surgeon Carmelo Otero performed the first U.S. clinical case at Christus Santa Rosa Hospital in San Antonio, Texas. The patient presented with paroxysmal atrial fibrillation, mitral and tricuspid valve and coronary artery disease. The AtriLaze surgical ablation procedure was performed as a concomitant procedure with mitral valve replacement and tricuspid valve repair. Use of the AtriLaze system added a minimal amount of time to the overall surgical procedure.

MedicalCV acquired rights to the AtriLaze Surgical Ablation System in September 2003 and received FDA 510(k) clearance on Nov. 30, 2004. The company is currently marketing the AtriLaze system for clinical use and is focusing its resources on the minimally invasive treatment of atrial fibrillation as a stand-alone procedure.