Pulse Biosciences has announced late-breaking data from the first-in-human feasibility study of its nanosecond pulsed field ablation (nsPFA) 360-degree cardiac catheter system at the recent 30th annual AF symposium (16–18 January 2025, Boston, USA).
The feasibility study in question is intended to assess the initial safety and efficacy of the company’s nsPFA 360-degree cardiac catheter system for the treatment of atrial fibrillation (AF). To date, 77 patients have been treated by six investigators, including Vivek Reddy (Mount Sinai Hospital, New York City, USA), Petr Neužil (Na Homolce Hospital, Prague, Czechia) and Johan Vijgen (Jessa Hospital, Hasselt, Belgium). The initial cohort of the first 30 patients treated have been evaluated by remapping completed at roughly three months post-ablation procedure.
“The remap results for the first 30 patients treated with the nsPFA 360-degree cardiac catheter demonstrate strong pulmonary vein isolation (PVI) with short case times,” said 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 detailed in a Pulse Biosciences press release, initial cohort study results are as follows:
- All lesions (100%) were acutely successful with conduction block
- Success rate of PVI at about three 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
- One primary serious adverse event (cardiac perforation), and two adverse events, including one case of vertigo (managed conservatively) and one of creatinine elevation (treated with intravenous saline); all adverse events were resolved without sequelae
In addition, also at the 2025 AF symposium, a live case transmission highlighted the nsPFA 360-degree cardiac catheter with 3D mapping and navigation on the Abbott Ensite X system. Neužil, and Moritoshi Funasako and Jan Petru (both Na Homolce Hospital, Prague, Czechia), performed a successful live case highlighting the catheters’ ability to rapidly isolate the pulmonary veins with a fast, efficient procedure workflow, as stated by the company’s recent release.
“We appreciate the support of the renowned EPs [electrophysiologists] who are performing the initial clinical work with our catheter ablation system and are presenting its clinical performance to their peers in the scientific community. We believe nanosecond PFA represents the next-generation energy modality that will improve the safety, efficacy and efficiency of AF ablation through a more straightforward and clinician-friendly procedure,” said Paul LaViolette, chief executive officer (CEO) and co-chairman of Pulse Biosciences. “We remain on track to begin an IDE [investigational device exemption] study this year for clinical validation of our devices and look forward to continuing our work with thought-leading physicians to achieve commercial approval, and deliver this technology to more patients and providers.”
