Pulse Biosciences Inc. is sharing encouraging first-in-human study results from its Nanosecond PFA 360° Cardiac Catheter System, which leverages the company’s proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology.

The feasibility study is intended to assess the initial safety and efficacy of the Nanosecond PFA 360° Cardiac Catheter System for treating atrial fibrillation (AF). To date, 77 patients have been treated by six investigators, including Dr. Vivek Reddy and Prof. Petr Neuzil, in cases performed at Na Holmolce Hospital in Prague and Dr. Johan Vijgen at Jessa Hospital in Hasselt. The initial cohort of the first 30 patients treated have been evaluated by remapping completed at about three months after the ablation procedure.

“The remap results for the first 30 patients treated with the Nanosecond PFA 360° Cardiac Catheter demonstrate strong pulmonary vein isolation (PVI) with short case times,” said Reddy, M.D., director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York City. “This 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.”

Initial cohort study results:

• All lesions were acutely successful with conduction block.
• Success rate of PVI at approximately 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 SAE (cardiac perforation) and two AEs including vertigo (n=1; managed conservatively) and creatinine elevation (n=1; treated with IV saline). All AEs were resolved without sequelae.

“We appreciate the support of the renowned EPs 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,” Pulse Biosciences Co-Chairman/CEO Paul LaViolette stated. “We remain on track to begin an IDE 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.”

Pulse Biosciences is a bioelectric medicine company whose proprietary CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The company is actively pursuing the development of its CellFX nsPFA technology for use in treating atrial fibrillation and in a select few other markets where it could positively impact healthcare for both patients and providers. Pulse Biosciences is now headquartered in Miami and maintains an office in Hayward, Calif.

* Dr. Reddy is a consultant to Pulse Biosciences as well as other companies developing pulsed field ablation catheters.