Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S.

Globally, more than 33 million people suffer from atrial fibrillation, nearly half of whom have continuous AF persisting for more than a year. The condition, which is characterized by an irregular and often rapid heart rate, raises the risk of stroke and death.

The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.

“With the approval of the Epi-Sense system, we are now able to market hybrid AF therapy as an option for the 45% of all AF patients who have long-standing persistent atrial fibrillation,” Justin Noznesky, Atricure’s chief marketing and strategy officer, told BioWorld.

Atricure shares (NASDAQ:ATRC) hit a high of $79.31 Thursday before ending the day at $76.00, up 8.8% from Wednesday’s close.

The Epi-Sense system is indicated for the treatment of patients with 12 months or more of continuous AF when coupled with an endocardial catheter who are refractory or intolerant to at least one class I and/or III antiarrhythmic drug and who expect the benefit from rhythm control outweighs the potential risks associated with a hybrid procedure.

CONVERGE trial

The FDA based its approval on the prospective, randomized, controlled, pivotal CONVERGE trial, which demonstrated superiority of Epi-Sense plus endocardial catheter ablation, compared with endocardial catheter ablation alone. In patients diagnosed with longstanding persistent atrial fibrillation, the hybrid therapy group showed a 29% absolute difference in efficacy at 12 months and 35% absolute difference at 18 months – for a relative improvement of 78% and 110%, respectively. The hybrid therapy arm also saw a 33% absolute difference in AF burden reduction at 12 months, which increased to 37% at 18 months.

The trial enrolled 153 patients at 27 sites in the U.S. and U.K.

Michael Carrel, president and CEO of Atricure, called the approval a “monumental step forward” for managing patients with the most advanced and difficult to treat cases of AF.

“This approval will enable us to educate and train physicians across the country on the benefits of hybrid AF therapy in treating long-standing persistent afib patients. In addition to superior clinical results, the procedure significantly improves electrophysiology lab efficiency by reducing endocardial ablation times by over 40 minutes, improving throughput and enabling more patients to be treated.”

The evidence from the CONVERGE trial should encourage cardiologists, electrophysiologists and surgeons, together, to consider the Epi-Sense procedure for this group of patients, said David DeLurgio, director of electrophysiology at Emory St. Joseph Hospital and the trial’s global principal investigator. “The improvement using the Epi-Sense system for posterior left atrial wall and pulmonary vein ablation, in conjunction with an endocardial catheter to address lesion gaps, is truly remarkable.”

He added that the AF burden reduction results are “especially encouraging,” as they mirror published data and experience outside of the trial.

The Epi-Sense system is already CE-marked for the treatment of cardiac arrhythmias, including AF.

‘$1B+ market opportunity’

Danielle Antalffy, a med-tech analyst with SVB Leerink, said Atricure management have hinted at a measured rollout, which could limit 2021 sales. However, with more than six months of commercialization this year, the company could see “meaningful sale growth acceleration” in 2022.

“With approval now under the company’s belt, ATRC has the ability to meaningfully unlock – what we believe is – a $1B+ market opportunity, and expand ATRC’s current TAM by almost 2.5x,” she wrote in a research note.

During a Tuesday earnings call, Carrel said the goal is for the Convergent, or hybrid, therapy to become the standard of care for the millions of patients with longstanding persistent AF.

“We continue to build a dedicated sales team and develop a robust infrastructure to support the commercial steps ahead. Currently, our U.S. sales and training team consists of more than 200 individuals in the field, who are all critical to supporting our hybrid therapy growth,” he said.

For the first quarter of 2021, minimally invasive ablation sales in the U.S. grew 28% year over year to $8.4 million. The company attributed the bump to an increase in elective procedures and Epi-Sense sales.