AtriCure has announced US Food and Drug Administration (FDA) approval of the EPi-Sense system to treat patients diagnosed with long-standing persistent atrial fibrillation (AF).
The CONVERGE trial demonstrated superiority in the hybrid AF therapy arm compared to endocardial catheter ablation alone. In patients diagnosed with long-standing persistent AF, 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 AF burden reduction in favour 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 AF,” said Michael Carrel, president and chief executive officer at AtriCure. “The long-standing persistent AF population represents over three million patients in the USA alone, or nearly half of all diagnosed AF 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 AF 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 AF 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, director of Electrophysiology at Emory St Joseph’s Hospital, Atlanta, USA 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, AF burden reduction results are especially encouraging as they mirror our experience as well as peer reviewed published data outside of the trial.”
“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, director of the Arrhythmia Service and the Clinical Electrophysiology Lab at Johns Hopkins University, Baltimore, USA. “These patients with advanced AF 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.”