Direct visual ablation system for patients with AF receives FDA approval

CardioFocus announced that its endoscopic ablation system has been approved by the FDA for treatment of patients with paroxysmal atrial fibrillation.

Approval for the ablation system that uses a visually guided laser balloon (HeartLight) was based on a study of 353 patients (mean age, 60 years; 34% women) presented at the Heart Rhythm Society Annual Scientific Sessions in May 2015, according to a company press release.

In that study, most of the patients were free from paroxysmal AF at 12 months, according to the release. The study also met its primary safety outcome of freedom from adverse events and was noninferior to standard-of-care radiofrequency ablation (P for noninferiority = .002).

According to the release, the device provides direct visual guidance to the electrophysiologist when isolating the pulmonary veins, unlike conventional radiofrequency ablation.

Vivek Y. Reddy

“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,” 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, who presented the findings at HRS 2015, said in the release. “The short learning curve of the new HeartLight System will enable even new users to quickly and efficiently deliver durable therapy to their patients.”

Disclosure: Reddy reports receiving consultant fees/honoraria and research grants from Biosense Webster and CardioFocus.