Pulse Biosciences said it has enrolled the first patients in its NanoPulse-AF IDE pivotal study of the NPulse cardiac catheter system for atrial fibrillation, with the first seven patients treated at St. Bernards Medical Center in Jonesboro, Arkansas.
The company is advancing the trial after reporting 96% procedural success at 12 months and 100% acute success in its first-in-human feasibility study. Pulse said the feasibility results were achieved across operators and without anti-arrhythmic drugs, and that typical recurrence in the field is 20% to 25%.
The pivotal study is planned to enroll about 215 participants across multiple sites in the U.S. and Europe, with as many as 30 centers expected to participate. Primary endpoints will be assessed at 6 and 12 months after ablation.
Pulse said the NPulse system delivers energy in nanoseconds and is designed to create pulmonary vein isolation with about 5 seconds per application. In prior feasibility work, the company said median left atrial dwell time was 21 minutes and total procedure time was about 65 minutes. As a result of these announcements, the company's shares have moved -2.36% on the market, and are now trading at a price of $21.50. For the full picture, make sure to review PULSE BIOSCIENCES, INC.'s 8-K report.
