CardioFocus, a company out of Marlborough, Massachusetts, won approval from the FDA to bring to market its HeartLight endoscopic cardiac ablation system for treatment of paroxysmal atrial fibrillation. Unlike other ablation catheters that rely on X-rays or EP cardiac mapping to guide the ablation, the HeartLight provides direct visual observation of the area where tissue is to be removed.
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.
Some details about the study that led to the approval:
The approved PMA submission contained comprehensive safety and effectiveness data from the Company’s multi-center HeartLight U.S. Pivotal Clinical Study, a randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the United States.
Results from the pivotal trial, announced at Heart Rhythm 2015, showed that when performing a single ablation procedure using the HeartLight System, the majority of patients experienced freedom from paroxysmal AF at 12 months. In addition, both the primary safety and efficacy endpoints were met.
Link: CardioFocus homepage…