Pulse Biosciences has announced favourable findings from the 60-day post-procedure evaluations for four initial patients treated in the Company’s CellFX nanosecond pulsed field ablation (nsPFA) 360° cardiac catheter first-in-human feasibility study.
“The 60-day remap results for the initial patients treated with the CellFX nsPFA 360° cardiac catheter in this feasibility study reveal favourable durable pulmonary vein isolation data,” said Vivek Reddy, director of cardiac arrhythmia services at the Mount Sinai Fuster Heart Hospital (New York, USA). “I look forward to sharing more details on the findings from this feasibility study, including the results of the 60-day mapping evaluation, at an upcoming scientific meeting. In the meantime, we are quite excited to continue to enrol and treat patients as we progress and assess this promising and novel CellFX nsPFA technology.”
“The 60-day treatment durability in these initial patients is an important step toward validating our unique nsPFA atrial fibrillation (AF) catheter solution. We are encouraged by the ease-of-use, speed, versatility, and now the initial durability outcomes of our novel catheter which is designed specifically for use with our nsPFA energy. I am extremely proud of the enthusiastic work and commitment to excellence manifested by team Pulse Biosciences. Our goal is to advance and reshape, for the betterment of all involved, the treatment of atrial fibrillation with the deployment of our CellFX nsPFA 360° cardiac catheter in electrophysiology,” said Kevin Danahy, president and chief executive officer of Pulse Biosciences. “We are excited to complete this clinical trial and further validate our game-changing technology.”
Using the Company’s CellFX nsPFA 360° cardiac catheter, 14 patients with AF have been successfully treated at Na Homolce Hospital in Prague, Czech Republic.
Patients treated with the Company’s CellFX nsPFA 360° cardiac catheter system are being evaluated at regular intervals to further document the safety and effectiveness of the treatments, and the company expects to enrol up to a total of 30 patients in the current feasibility study. The company has remapped the first four of the initial 14 patients treated. The observations to date have been positive, but the broad set of risks associated with cardiac surgery remain.
