Pulse Biosciences (Nasdaq:PLSE) today announced favorable findings from post-procedure evaluations of its CellFX pulsed field ablation system.
The 60-day post-procedure evaluations looked at four initial patients treated in the company’s first-in-human feasibility study. This study, which kicked off in December 2023, looks at Pulse’s novel, proprietary CellFX nanosecond PFA technology for treating AFib.
Dr. Vivek Reddy of Mount Sinai Hospital (New York) and Dr. Petr Neuzil of Na Homolce Hospital, Prague, and colleagues performed the first procedures. Reddy said in a news release today that the initial results reveal favorable durable pulmonary vein isolation data.
Using the CellFX nsPFA 360° cardiac catheter, doctors have successfully treated 14 patients with AFib to date at Na Homolce. Investigators have evaluations underway at regular intervals to further document the safety and effectiveness of the treatments.
Pulse Biosciences expects to enroll up to a total of 30 patients in the current feasibility study. The company also remapped the first four of the initial 14 patients treated with these 60-day evaluations. Pulse Biosciences reports positive observations to date but notes the “broad set of risks associated with cardiac surgery.”
“The 60-day treatment durability in these initial patients is an important step toward validating our unique nsPFA 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,” said Kevin Danahy, president and CEO. “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.”
Pulsed field ablation is one of the hottest spaces in medtech. Biosense Webster recently had positive data hoping to propel its Varipulse system toward establish itself among fierce competition. Boston Scientific won FDA approval for its Farapulse system last week. That came shortly after Medtronic won the first FDA nod for PFA to treat paroxysmal and persistent AFib.