The Excalibur Balloon used in conjunction with the currently approved HeartLight device.Courtesy of CardioFocus
CardioFocus is looking to bring the next generation of its endoscopic ablation system to the market and that could happen sometime next year. The Marlborough, MA-based company and finalist in MD+DI’s Manufacturer of the Year Award in 2012, took bold steps on this front this past week by completing enrollment for a trial evaluating its HeartLight X3 System.
The HeartLight X3 System uses laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause atrial fibrillation, the most common type of cardiac rhythm disorder.
Roughly 60 patients were treated with the HeartLight X3 System in the pivotal confirmatory trial with a one-month follow up. CardioFocus’s trial will evaluate time, safety, and acute outcomes using the HeartLight X3 System in the treatment of AFib as pivotal endpoints.
“We anticipate submitting for regulatory approval in Europe in the first quarter of next year,” Omari Bouknight, president and Chief Commercial Officer, for CardioFocus, told MD+DI. “We anticipate having approval in Europe sometime mid-2019. On the U.S. side of things, we’re currently in discussions with FDA on what the submission will require. We’re still in conversations with them in terms of what the regulatory path is, so we don’t have a strict timeline for approval in the U.S. We’ll probably have a good timeline of that in Q1 or Q2 of next year.”
The technology builds off the current HeartLight Endoscopic Ablation System, which received FDA clearance in 2016.
CardioFocus is in a position where it is earning revenue and there aren’t any plans for an upcoming financing raise, Bouknight said. However, the company has some pretty big players to go up against in the market.
Abbott Laboratories and Biosense Webster both use radiofrequency-based technologies to treat AFib patients.
The other energy source used to treat these patients in cryogenic. Medtronic uses this approach with its Arctic Front Advance Cryoablation system. In August, the Dublin-based company revealed results from the Cryo4Persistent AFib clinical trial at the European Society of Cardiology Congress. Data from the study showed a low rate of re-interventions along with repeat ablations, and reductions in the symptoms abnormal heart rhythms.