NORTON, Mass., March 29 -- CardioFocus Inc. has received FDA 510(k) clearance to market its diode laser for use in surgery. This laser is used by clinicians with the accompanying Optimaze surgical ablation handpiece, previously cleared by the FDA for use on cardiac tissue. Together, the laser and handpiece are used to create lesions in the heart during cardiac surgery. The Optimaze Surgical Ablation System will be marketed worldwide exclusively by Edwards Lifesciences Corporation.
The Optimaze system creates lesions in the heart with a less-invasive and less time-consuming approach, employing a malleable laser tip that can be shaped by the surgeon to create precise lesions in virtually any configuration. These transmural (i.e., through the heart wall) lesions can be created in cardiac tissue in less than a minute.