CardioFocus has received FDA premarket approval for its HeartLight endoscopic ablation system. The system is designed to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF).
The HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with high procedural flexibility, according to Mass Device. The device comes with a compliant balloon to accommodate diverse pulmonary venous anatomies.
The approval is based on data from a 353-patient, multi-center pivotal clinical study. It met the safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure.
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Subjects in the pivotal study of the HeartLight device were randomly assigned to treatment with either the laser balloon or standard radiofrequency ablation. According to co-principal investigator Vivek Y. Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and The Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai:
Novel medical devices have a challenging path to approval and are evaluated through intensive comparison with control arm devices that are inherently more familiar to the study investigators. The short learning curve of the new HeartLight System will enable even new users to quickly and efficiently deliver durable therapy to their patients.
