CardioFocus, Inc. premarket approval (PMA) from FDA for its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF).
The device consists of a compliant balloon at the distal end and an optical fiber that can deliver laser energy into the heart. A separate lumen is used to position device that lets the physician visualize the area under the laser gun.
The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs).
The device consists of a compliant balloon at the distal end and an optical fiber that can deliver laser energy into the heart. A separate lumen is used to position device that lets the physician visualize the area under the laser gun.
The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs).
More info available from Cardio Focus Inc. website.
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