CardioFocus said today it won FDA premarket approval for its HeartLight endoscopic ablation system, indicated for treating drug refractory recurrent symptomatic paroxysmal AF.
The approval is based on data from a 353-patient, multi-center pivotal clinical study which met the primary safety and efficacy endpoints and reported freedom from paroxysmal AF at 12 months post-procedure, the Marlborough, Mass.-based company said.
“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,” co-principal investigator Dr. Vivek Reddy of the The Mount Sinai Hospital said in a press release.
The newly cleared HeartLight system allows electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with a high procedural flexibility, a company spokesperson wrote to MassDevice.com.
The device includes a compliant balloon to accommodate diverse PV anatomies and has a short learning curve to allow for quick adoption of the tech.
“The achievement of the HeartLight System PMA approval is a major milestone and the result of dedicated teamwork among our employees, the clinical sites and study participants, and we are grateful for this remarkable support. It is also important to highlight the efficiency and professionalism of the FDA, reflected in this PMA review from filing to approval in eight months. The HeartLight System represents a novel approach to ablation for the treatment of AF and we look forward to making it available in the U.S. for electrophysiologists and their patients,” regulatory & clinical affaris veep Burke Barrett said in prepared remarks.
Last May, CardioFocus touted that its visually-guided laser balloon ablation system is as effective as standard ablation in treating paroxysmal atrial fibrillation.
Subjects in the pivotal study of the HeartLight device were randomly assigned to treatment with either the laser balloon or standard RF ablation.
Data showed that the treatments were similar, although treatment time was much higher for the VGLB arm and required more time under fluoroscopy. Reddy said that was most likely due to the novelty of the Heartlight device.
As the technology becomes more standard and physicians gain more experience with it, efficacy, safety and treatment times would all improve, he added
The rate of phrenic nerve palsy in VGLB treatments was higher than in standard ablation, at 3.5% versus 0.6%. Reddy said that although phrenic nerve injuries should be treated seriously, most cases were asymptomatic and all but 1 case in the study had recovered within 12 months.
Expanded results published last September in the Journal of the American College of Cardiology bore that out, with increased operator experience resulting in significant improvements in time under fluoroscopy and non-significant improvements in procedure time, efficacy and safety, the researchers wrote.