AtriCure is one step closer to getting its Convergent atrial fibrillation (Afib) treatment approach a nod from FDA. The Mason, OH-based company said it has fully completed enrollment of the full cohort of 153 patients in the CONVERGE IDE clinical trial.
AtriCure said the trial will compare the Convergent approach to endocardial catheter ablation for patients with persistent or long-standing persistent Afib.
“The full enrollment of the CONVERGE clinical trial is a significant milestone for AtriCure,” Mike Carrel, president and CEO of AtriCure said in a release. “This study is the first of its kind, evaluating the multi-disciplinary Convergent approach against catheter ablation for patients who suffer from the most serious forms of Afib. We believe that once concluded, this study will be a meaningful step forward in demonstrating the safety and effectiveness of the Convergent approach.”
The CONVERGE study’s primary efficacy endpoint is for enrolled patients to be Afib, atrial tachycardia, and atrial flutter free, absent class I and III AADs except for a previously failed or intolerant class I or III anti-arrhythmic drugs, with no increase in dosage following the 3-month blanking period through the 12 months’ post procedure follow-up visit. The last patient follow-up is expected to be sometime in 3Q19, after which the company will submit final documentation to FDA and seek a PMA.
AtriCure has had a lot of momentum recently. In July the company was listed as one of the 25 most attractive medtech companies on the M&A radar.