Massachusetts-based medical device maker CardioFocus announced the launch of a new clinical trial of its HeartLight endoscopic ablation system for atrial fibrillation, this time spanning multiple centers across Europe.
The study will enroll 150 patients at 5 centers in Germany and the Czech Republic, and it will be the 1st to prospectively evaluate pulmonary vein isolation with balloon ablation catheters in patients with persistent atrial fibrillation, according to a company report.
The device has had CE Mark approval in the European Union since July 2009. It’s had investigational device exemption from the FDA since December 2011.
"European clinical experience to date has confirmed the clinical advantages of HeartLight’s direct visualization capabilities and unique laser energy source; this new study will assess the value of achieving durable PVI in this challenging-to-treat population," president Stephen Sagon said in prepared remarks.
The medical device maker last year launched a U.S. pivotal trial of its HeartLight technology, a device which the company says is the 1st of its kind to to allow direct visualization of a beating heart in real time, without using radiation, to allow physicians to better aim delivery of ablation energy.
The U.S. trial pits the HeartLight system against Biosense Webster’s NaviStar system-guided Thermocool catheter in a randomized trial of an estimated 350 patients at up to 25 U.S. sites.