AtriCure Reports 1st Treatments with Dual Energy RF, PFA System

AtriCure announced successful first-in-human treatments using its dual energy platform that integrates pulsed field ablation (PFA) with advanced radiofrequency ablation (advanced RFA).

According to the company, advanced RFA reduces ablation time significantly, while PFA allows transmural ablation in seconds. For the first two patients treated, total procedural ablation time to create a box lesion simultaneously isolating the pulmonary veins and left atrial posterior wall was under a minute. Each ablation was also tested to prove acute electrical isolation.

“For 25 years, we’ve been the leader in cardiac surgical ablation,” said Michael Carrel, president and CEO of AtriCure. “Our innovative EnCompass clamp technology was a significant step in streamlining cardiac surgery ablation procedures. Now, building on the proven performance of our EnCompass clamp, this platform offers the best of both worlds. By pairing Advanced RFA with PFA, we’re delivering unprecedented speed and flexibility for surgeons.”

The company’s Isolator Synergy ablation system is supported by extensive published data, including over 100 publication, and has been used in treatment of over 450,000 patient in the last two decades. AtriCure began developing the dual energy platform with the aims of shortening RF ablation times and introducing PFA as a complementary energy source. Thse system lets surgeons use either mode independently, or in combination.

The first procedures were performed by Dr. Adrian Pick in collaboration with the site Principal Investigator Professor Jayme Bennetts, at Victorian Heart Hospital in Australia under approval from the Monash Health Human Research Ethics Committee (HREC).

“This technology builds on AtriCure’s strong legacy in cardiac surgical ablation,” said Dr. Pick. “Reduced procedure times and trusted devices mean more patients can benefit, and combining the benefits of RF with PFA should further ensure durable results.”

The advanced RFA and PFA technologies are not yet approved for use in any market. AtriCure expects to initiate a clinical trial in the coming year.

In October, the company enrolled and treated the first in its Box Lesion Creation with Left Atrial Appendage Exclusion to Reduce the Occurrence of New-onset Atrial Fibrillation (BoxX-NoAF) clinical trial.