AtriCure's EPi-Sense System Approved by FDA for Treatment of Long-Standing Persistent Afib Patients

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AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced U.S. Food and Drug Administration (FDA) approval of the EPi-Sense(R) System to treat patients diagnosed with long-standing persistent Afib. The CONVERGE(TM) trial demonstrated superiority in the hybrid AF(TM) therapy arm compared to endocardial catheter ablation alone. In patients diagnosed with long-standing persistent Afib, the hybrid therapy arm showed a 29% absolute difference in efficacy at 12-months (78% relative improvement) and an absolute difference of 35% at 18 months (110% relative improvement). There was also a 33% absolute difference in Afib burden reduction in favor of the hybrid AF therapy at 12 months, which increased to 37% at 18 months.

"FDA approval is a monumental step forward in the market focused on patients with the most advanced and difficult to treat Afib," said Michael Carrel, President and Chief Executive Officer at AtriCure. "The long-standing persistent Afib population represents over three million patients in the United States alone, or nearly half of all diagnosed Afib patients. 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."

"This therapy should help change the standard of care and improve the lives of millions of patients. Due to less than optimal outcomes with endocardial ablation alone, many patients in whom Afib has progressed are not even considered for ablation treatment today. The high-quality evidence from the CONVERGE trial should encourage cardiologists, electrophysiologists and surgeons, as a team, to consider this procedure for these patients," said David DeLurgio, M.D., Director of Electrophysiology at Emory St. Joseph's 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 combination with an endocardial catheter to address lesion gaps, is truly remarkable. Additionally, Afib burden reduction results are especially encouraging as they mirror our experience as well as peer reviewed published data outside of the trial."

Afib affects over 33 million people worldwide and approximately 45% of those people have long-standing persistent Afib.1 Afib increases the risk of stroke and is linked with increased risk of mortality. The number of people with Afib is expected to increase significantly over the next decade.

"Hybrid AF therapy is the only FDA-approved minimally invasive ablation procedure to treat patients who have been in continuous Afib for more than one year, which is a large number of my patients," said Hugh Calkins, M.D., Director of the Arrhythmia Service and the Clinical Electrophysiology Lab at Johns Hopkins University. "These patients with advanced Afib are very difficult to treat with catheter ablation alone. The data from the CONVERGE trial is compelling, and patients will benefit greatly from having this treatment."

18-Month Data Shows Durability

Data from the CONVERGE trial at 18 months has shown that hybrid AF therapy provides durable, sustained efficacy. In the treatment arm, freedom from all arrhythmias in the long-standing persistent population was 61%, versus 26% for endocardial catheter ablation alone. Freedom from Afib alone at 18-months was 68% for hybrid AF therapy, versus 30% in the catheter ablation arm for the same group of patients.

"These 18-month results are incredible and demonstrate the durability of the procedure," said Dr. DeLurgio. "This is a key finding from the trial and shows that patients who undergo a hybrid procedure should expect continued freedom from Afib. I'm really looking forward to seeing this therapy expand and impact more patients who have no other effective treatment options."

Table 1: Effectiveness endpoints for long-standing persistent AF sub-group (12-month follow up)