CardioFocus Finishes up Enrollment for HeartLight X3 Trial

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. One 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 go...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Cardiovascular Source Type: news