CardioFocus has announced the first commercial US procedure using its HeartLight Endoscopic Ablation system for the treatment of patients with paroxysmal atrial fibrillation (AF) at The Mount Sinai Hospital in New York City. The HeartLight System received premarket approval from the US Food and Drug Administration (FDA) in April 2016. This procedure marks the initiation of the company’s commercialisation of the system in USA.
The first commercial HeartLight procedure was successfully performed on 26 September. The procedure was led by Srinivas R Dukkipati, director of the Electrophysiology Lab and co-director of Cardiac Arrhythmia Services at The Mount Sinai Hospital, New York, USA. Dukkipati is a clinical investigator in the HeartLight pivotal trial, and lead author of the pivotal study results article published in the Journal of The American College of Cardiology (JACC).
“More than 2.7 million people in the United States alone suffer from AF, and despite treatment advancements, the numbers are growing, mostly due to an aging population. Treating paroxysmal AF before it advances to a persistent or permanent state will drastically improve patient long-term outcomes,” says Dukkipati. “The HeartLight system offers a new approach to effective patient treatment through direct visualisation, titratable energy and a compliant balloon design, all of which lead to durable pulmonary vein isolation with unprecedented access and control.”
“Following approval from the US FDA, we are pleased to now commercially offer HeartLight for paroxysmal AF patients in the US market. HeartLight has already been used to treat more than 3,700 patients worldwide, and building on the first commercial US procedure at Mount Sinai, we will continue to scale up installations at electrophysiology labs across the country to treat patients in need,” comments Paul LaViolette, CardioFocus executive chairman.
“HeartLight differs from other AF ablation solutions by allowing electrophysiologists to see within the heart and for the first time, visually direct the application of therapeutic laser energy. The system also allows for procedural flexibility through a highly compliant balloon that easily accommodates diverse anatomies,” says Burke Barrett, CardioFocus chief operations officer.” We are excited to offer the technology, following premarket approval based on our pivotal US study that showed the majority of patients experienced freedom from paroxysmal AF at 12 months following a single ablation procedure. Both Dr Dukkipati and Dr Reddy have been instrumental in evaluating the HeartLight system so it is fitting that Mount Sinai is the first US commercial HeartLight centre.”