AtriCure (NSDQ:ATRC) announced today that the FDA approved its EPi-Sense system for treating long-standing persistent atrial fibrillation (Afib).
Mason, Ohio-based AtriCure’s EPi-Sense system demonstrated superiority in the Hybrid AF therapy arm compared to endocardial catheter ablation alone in the Converge clinical trial, according to a news release.
AtriCure’s Hybrid AF therapy is a minimally invasive procedure designed to provide a long-lasting solution for long-standing, persistent Afib patients.
In patients diagnosed with long-standing, persistent Afib, the Hybrid AF therapy arm presented a 29% absolute difference in efficacy at 12 months (78% relative improvement) and an absolute difference of 35% at 18 months (110% relative improvement).
Afib burden was reduced by 33% in the Hybrid AF group at 12 months and fell to 37% at 18 months, with the Converge trial proving that the Hybrid AF therapy offers durable, sustained efficacy, AtriCure said.
Freedom from all arrhythmias in the long-standing, persistent Afib population was 61% in the treatment arm compared to 26% in the group that received endocardial catheter ablation alone. Freedom from Afib alone at 18 months totaled 68% in the Hybrid AF group compared to 30% in the catheter ablation arm for the same group of patients.
“FDA approval is a monumental step forward in the market focused on patients with the most advanced and difficult to treat Afib,” AtriCure president & CEO Michael Carrel said in the release. “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,” Carrel added.