Dr. Carmelo Otero, Cardiothoracic and Vascular Surgeon, performed the first United States clinical case at Christus Santa Rosa Hospital in San Antonio, Texas. The 53 year old, female patient presented with paroxysmal atrial fibrillation (A-Fib), 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.
"The AtriLaze system performed well, allowing me to easily and precisely replicate Maze lesions", stated Dr. Otero. "The laser technology provides me the capability to safely and quickly create an array of cardiac lesions that enabled today's successful clinical case. The AtriLaze system facilitates a simple, reproducible technique that I believe will be very effective in concomitant cardiac surgical procedures and potentially lends itself to minimally invasive and robotic surgical treatments of A-Fib", commented Dr. Otero.
Marc P. Flores, President and Chief Executive Officer of MedicalCV Inc., commented: "We are pleased to enter the United States market with this innovative technology for surgical cardiac tissue ablation. The atrial fibrillation market is in a state of chaos looking for an ideal technological solution to provide a minimally invasive surgical option that mirrors outcomes of the gold standard surgical Maze procedure. This successful surgery represents a further milestone in the company's goal of providing a better treatment solution for ablating cardiac tissue."
MedicalCV Inc. acquired rights to the AtriLaze Surgical Ablation System in September 2003 and received FDA 510(k) clearance on November 30, 2004. The company is currently marketing the AtriLaze system for clinical use and is focusing its resources on the minimally invasive treatment of A-Fib as a stand-alone procedure.
"The laser's physical properties are a specific balance of absorption and transmission through atrial tissue that optimizes overall photocoagulation", stated Adam L. Berman, Vice President, Research and Development. "Through our continued development efforts, we believe the delivery of light energy through low-profile fiberoptic elements has the potential to enable closed-chest, beating heart procedures for cardiac tissue ablation."
MedicalCV, a cardiovascular surgery device manufacturer, focuses on the design, development and commercialization of new, improved and enhanced technologies, products, methods and techniques to treat cardiovascular disorders and disease, including products targeting the treatment of atrial fibrillation. Historically, MedicalCV developed and marketed Omnicarbon mechanical heart valves and its proprietary pyrolytic carbon processes. The company acknowledges their continued maintenance of the mechanical heart valve business, supporting their customers and distributors during the divestiture process. The company also continues to concentrate it resources on the A-Fib market.