Pulse Biosciences said its Nanopulse-AF IDE pivotal study has hit full enrollment, with 164 evaluable patients enrolled across 15 clinical sites.
The company said the trial reached that target three months ahead of its original nine-month timeline. The study’s first patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas.
The enrollment pace accelerated as the site count expanded to 15 centers, according to the company, which said investigators began enrolling steadily after initial cases. Pulse Biosciences said the study will now move through follow-up, with primary endpoints to be assessed at 6 and 12 months post-ablation.
The Nanopulse-AF study is evaluating the Npulse cardiac catheter system in patients with drug-resistant, symptomatic, paroxysmal atrial fibrillation. The company said it expects to present pivotal data at a future medical society conference. Following these announcements, the company's shares moved -1.49%, and are now trading at a price of $49.75. Check out the company's full 8-K submission here.
