Pulse Biosciences Nanosecond PFA 360° Evaluated in FIH Feasibility Study

January 27, 2025—Pulse Biosciences, Inc. recently announced late-breaking data from the first-in-human feasibility study of the company’s Nanosecond pulsed field ablation (nsPFA) 360° cardiac catheter system in the treatment of atrial fibrillation (AF). The data were presented at the 30th Annual AF Symposium 2025 meeting held January 16-18 in Boston, Massachusetts.

The initial cohort of the first 30 patients treated were evaluated by remapping completed at approximately 3 months after the ablation procedure, advised the company.

According to Pulse Biosciences, the feasibility study is intended to assess the initial safety and efficacy of the nsPFA 360° cardiac catheter system for the treatment of AF. To date, 77 patients have been treated by six investigators, including Vivek Reddy, MD, and Professor Petr Neuzil, MD, in procedures at Na Holmolce Hospital in Prague, the Czech Republic, as well as Johan Vijgen, MD, at Jessa Hospital in Hasselt, Belgium.

Dr. Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York, New York, discussed the findings in the company’s press release.

“The remap results for the first 30 patients treated with the nsPFA 360° cardiac catheter demonstrate strong pulmonary vein isolation (PVI) with short case times,” stated Dr. Reddy. “This novel technology offers a unique user experience that has the potential to improve workflow with a pliable catheter for nimble and precise positioning in the anatomy, and combined with the differentiated energy, enables consistent, durable transmural ablations.”

As outlined in the Pulse Biosciences press release, the initial cohort study results include the following:

• All (100%) lesions were acutely successful with conduction block.
• The success rate of PVI at approximately 3 months was 92.4% (109/118).
• Total PVI ablation time was 11.6 ± 4.5 minutes.
• Total procedure and fluoroscopy times were 88.3 ± 30.1 and 6.9 ± 2.4 minutes, respectively.
• Left atrial dwell time was 29.6 ± 15.3 minutes.
• There was one primary serious adverse event (cardiac perforation) and two adverse events, including vertigo (n = 1; managed conservatively) and creatinine elevation (n = 1; treated with intravenous saline). All adverse events were resolved without sequelae.

Additionally, the company noted that at the AF Symposium, a live case transmission highlighted the nsPFA 360° cardiac catheter with three-dimensional mapping and navigation on the EnSite X system (Abbott). Prof. Neuzil, Moritoshi Funasako, MD, and Jan Petru, MD, performed a successful live case highlighting the ability of the nsPFA 360° cardiac catheter to rapidly isolate the pulmonary veins with a fast, efficient procedure workflow.