CardioFocus has announced that it has received premarket approval from the US Food and Drug Administration (FDA) for its HeartLight Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation.
The approved premarket approval submission contained comprehensive safety and effectiveness data from the company’s multicentre HeartLight US Pivotal Clinical Study, a randomised, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centres across the United States.
Results from the pivotal trial, announced at the Heart Rhythm Society Scientific Sessions in 2015, showed that when performing a single ablation procedure using the HeartLight System, the majority of patients experienced freedom from paroxysmal atrial fibrillation at 12 months. In addition, both the primary safety and efficacy endpoints were met.
In a company release, CardioFocus states that this granting positions them as one of very few manufacturers possessing a specific indication for catheter ablation therapy of paroxysmal atrial fibrillation. Specifically, in the United States, the HeartLight System is now indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
The HeartLight System differs from other atrial fibrillation solutions 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. The HeartLight System is designed to provide the clinician maximum procedural flexibility with a highly compliant balloon that easily accommodates diverse pulmonary anatomies and laser energy that the clinician delivers under direct endoscopic visualisation.
Co-principal investigator Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute, Center for Atrial Fibrillation at St David’s Medical Center in Austin, USA comments: “This was a large study and the device clearly met both primary safety and efficacy endpoints. I am confident these results, produced by physicians who were new to the laser balloon, demonstrate the promise of the HeartLight technology in routine clinical use.”
Further, co-principal investigator Vivek Y Reddy, 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, New York, USA, says: “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.”
Frank Cuoco, FACC associate professor of Medicine, Division of Cardiology at the Medical University of South Carolina in Charleston, USA, was one of the highest enrollers of patients in the HeartLight study, he adds: “We are excited about the approval of the HeartLight endoscopically-guided laser ablation catheter. Based on our experience in the CardioFocus pivotal study and the successful results from the EU, I am confident that this new laser balloon catheter will offer our patients an outstanding treatment option for atrial fibrillation. The flexibility of the compliant balloon, which is intuitive to use under direct visual guidance, is one of its primary appeals. I found the learning curve to be very short.”
On behalf of CardioFocus, vice president of Regulatory & Clinical Affairs Burke Barrett says, “The achievement of the HeartLight System premarket 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 premarket approval review from filing to approval in eight months. The HeartLight System represents a novel approach to ablation for the treatment of atrial fibrillation and we look forward to making it available in the USA for electrophysiologists and their patients.”
The US pivotal clinical study results are added to dozens of independent studies supporting the CardioFocus HeartLight System. Several published EU single-centre studies have reported high rates up to 80% of freedom from atrial fibrillation recurrence measured one year or more after the performance of a single ablation procedure. To date, more than 3,400 patients worldwide have been treated using the CardioFocus HeartLight System.