AtriCure reports that it successfully performed its first two human procedures with a new dual‑energy ablation platform that integrates pulsed‑field ablation (PFA) and advanced radiofrequency ablation (RFA) on its EnCompass clamp. The procedures were carried out at Victorian Heart Hospital in Australia under approval from the Monash Health Human Research Ethics Committee.
The platform delivers the rapid, transmural lesions of PFA while allowing the surgeon to add RFA for additional lesion creation. In both cases the total ablation time to create a box lesion isolating the pulmonary veins and left atrial posterior wall was under 60 seconds, and each lesion set was tested for acute electrical isolation, confirming the platform’s efficacy. The short procedure time and immediate isolation demonstrate the potential for faster, more efficient surgical workflows compared with conventional RFA alone.
Strategically, the hybrid approach positions AtriCure to compete directly with catheter‑based PFA systems while preserving its surgical moat. By combining the speed of PFA with the durability of its proven RFA clamp, the company offers a surgical alternative that could reduce operating room time and improve patient recovery, addressing a key market demand for faster, safer ablation solutions.
AtriCure plans to initiate a multicenter clinical trial in 2026 to evaluate long‑term safety and efficacy. The company is pursuing regulatory submissions in the United States and Europe, with expected FDA and CE Mark approvals in the next 12–18 months. The trial will also provide data to support a broader market launch and to differentiate the platform from existing catheter‑based PFA devices.
In its latest quarterly results, AtriCure reported revenue of $134.3 million, up 15.8% year‑over‑year, and a gross margin of 75.5%, an improvement from 74.9% in the prior year. The company’s adjusted EBITDA rose to $17.8 million, reflecting disciplined cost management amid expanding product mix. Management highlighted the strong demand for its surgical ablation solutions and the momentum generated by the new dual‑energy platform as key drivers of the financial performance.
Michael Carrel, President and CEO, said the milestone “demonstrates AtriCure’s commitment to innovation and its ability to deliver faster, more effective surgical solutions.” Dr. Adrian Pick, who performed the procedures, added that the combination of RF and PFA “provides durable results while reducing procedure time, which is a win for both surgeons and patients.”
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