CardioFocus Inc.‘s atrial ablation catheter was used for the first time in a U.S. clinical trial by physicians at The Mount Sinai Medical Center.
The Marlborough, Mass.-based company’s device is a visually-guided balloon catheter that uses a rotating laser to ablate the tissue surrounding the pulmonary artery’s entrance into the heart, to reduce atrial fibrillation.
The patient was a 58-year old man with a history of paroxysmal atrial fibrillation that drugs had failed to control. He agreed to the procedure with the CardioFocus Endoscopic Ablation System as part of a pre-marketing clinical trial under an investigational device exemption from the Food & Drug Administration.
In July, CardioFocus won CE Mark approval in the European Union for the device. The company also drummed up $6 million in a debt sale in June.