AtriCure has announced that the FDA has approved its EPi-Sense system for the treatment of long-standing persistent atrial fibrillation (Afib). This approval marks a significant advancement in the treatment of a patient population that has been historically difficult to manage.
The approval was based on the results of the Converge clinical trial, which compared AtriCure’s Hybrid AF therapy, utilizing the EPi-Sense system, to endocardial catheter ablation alone. The Hybrid AF therapy is a minimally invasive procedure designed to provide a lasting solution for patients with long-standing, persistent Afib.
The Converge trial demonstrated a significant improvement in efficacy with the Hybrid AF therapy. Specifically, patients in the Hybrid AF therapy arm showed a 29% absolute difference in efficacy at 12 months (78% relative improvement) and a 35% absolute difference at 18 months (110% relative improvement) when compared to the endocardial catheter ablation group. Furthermore, the Afib burden was reduced by 33% in the Hybrid AF group at 12 months and fell to 37% at 18 months.
According to AtriCure, 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.
Impact on Electrophysiology Labs
Beyond the clinical benefits, the EPi-Sense system also offers practical advantages for electrophysiology labs. "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," said Michael Carrel, president & CEO of AtriCure.
Addressing a Significant Unmet Need
"FDA approval is a monumental step forward in the market focused on patients with the most advanced and difficult to treat Afib," Carrel added. He noted that the long-standing, persistent Afib population represents over three million patients in the United States alone, nearly half of all diagnosed Afib patients. This approval will enable AtriCure to educate and train physicians across the country on the benefits of Hybrid AF therapy in treating these patients.
