Pulse Biosciences Shares Positive 60-Day Data for CellFX Nanosecond Pulsed Field Ablation

Pulse Biosciences reported favorable findings from post-procedure evaluations of its CellFX nanosecond pulsed field ablation (nsPFA) for atrial fibrillation (AFib).
 
The 60-day, first-in-human feasibility study evaluated four initial patients at Na Homolce Hospital in Prague. To date, 14 patients with AFib have been successfully treated with the CellFX nsPFA 360° cardiac catheter at Na Homolce.
 
Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York, said the results of the feasibility study showed promising durable pulmonary vein isolation data.
 
“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,” said Dr. Reddy. “In the meantime, we are quite excited to continue to enroll and treat patients as we progress and assess this promising and novel CellFX nsPFA technology.”
 
Pulse Biosciences anticipates enrolling up to 30 patients in the feasibility study and has remapped the first four of the initial 14 patients treated. The company shared positive observations to date, but noted the “broad set of risks associated with cardiac surgery remain.”
 
“The 60-day treatment durability in these initial patients is an important step toward validating our unique nsPFA AF catheter solution,” said Pulse Biosciences president and CEO Kevin Danahy. “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. We are excited to complete this clinical trial and further validate our game-changing technology.”
 
The pulsed field ablation (PFA) market is very active in the medical device industry. Last week Johnson and Johnson MedTech’s Biosense Webster reported positive data for Varipulse, and Boston scientific announced U.S. Food and Drug Administration (FDA) approval for Farapulse a weak before that. Abbott completed the first procedures with its Volt PFA in mid-January. Medtronic gained the first for its PulseSelect PFA system to treat both paroxysmal and persistent AFib late last year.