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# FDA Approves CardioFocus HeartLight Ablator for AF
- URL: https://www.fdaweb.com/fda-approves-cardiofocus-heartlight-ablator-for-af/
- Published: 2016-04-04T12:00:00.000Z
- Updated: 2026-09-14T20:52:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135272

> FDA has approved a CardioFocus PMA for its HeartLight Endoscopic Ablation System for treating patients with paroxysmal atrial fibrillation (AF). The device differs from other AF options 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 company says. “The HeartLight System is designed to provide the clinician maximum procedural flexibility with a highly compliant balloon that easily accommodates diverse PV anatomies and laser energy that the clinician delivers under direct endoscopic visualization.”  
>  
> Approval was based on data from the company’s multi-center HeartLight U.S. pivotal clinical study, a randomized, controlled study involving 353 participants. Results from the study, 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,” CardioFocus says. In addition, both primary safety and efficacy endpoints were met.