CardioFocus successfully treated the first patient in a pivotal trial of its HeartLight endoscopic ablation system for atrial fibrillation.
The HeartLight device is the first 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, according to a press release.
"For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes," principal investigator Dr. Vivek Reddy, of Mount Sinai School of Medicine, said in prepared remarks. "The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device."
The trial will pit 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.
The HeartLight device is a visually guided balloon catheter that uses a rotating laser to ablate the tissue surrounding the pulmonary artery’s entrance into the heart.
In May 2011 CardioFocus touted clinical data showing 99% acute isolation of the pulmonary vein with about 86% remaining persistently isolated after 3 months. Additional research suggested that 65% of patients retained durable freedom from atrial fibrillation after a single procedure with the HeartLight.
CardioFocus won investigational device exemption and with it permission to launch clinical trials in December 2011. The device has had CE Mark approval in the European Union since July 2009.
"Beginning this pivotal trial is a key milestone for CardioFocus and our technology, as it brings us one step closer to offering the HeartLight EAS treatment option to patients in the U.S.," president & CEO Stephen Sagon said in prepared remarks.
CardioFocus will have some stiff competition should it hit the market.
St. Jude Medical Inc. (NYSE:STJ) won pre-market approval for 2 next-generation cardiac ablation systems earlier this month, the Therapy Cool Path Duo and Safire Blu Duo catheters.
And Medtronic’s (NYSE:MDT) Arctic Front cryoballoon ablation system won PMA approval in December 2010, but hit an obstacle with another of its atrial fibrillation devices when the FDA’s circulatory devices panel said "not yet" to Medtronic’s Phased radiofrequency ablation system.