Pulse Biosciences said its Nanopulse-AF IDE pivotal study has hit full enrollment, with 164 evaluable patients now enrolled across 15 clinical sites.
The company said the trial reached that target three months ahead of its original nine-month timeline. The study opened at 15 centers, and the first patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas.
The study is evaluating the Npulse cardiac catheter system in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. Primary endpoints are set to be assessed at 6 months and 12 months after ablation.
The pace of enrollment appears to have accelerated as more sites came online. Pulse Biosciences said investigators were able to activate the 15 sites quickly, and once operators completed one or two cases, enrollment continued steadily. The company said it will provide further updates as patients complete follow-up and expects pivotal data to be presented at a future medical society conference.
The announcement marks a key milestone for the company’s cardiac program, moving the study from enrollment into the follow-up phase. As a result of these announcements, the company's shares have moved -1.49% on the market, and are now trading at a price of $49.75. For more information, read the company's full 8-K submission here.
