Along with the data, Paul LaViolette, the company’s new CEO and co-chair, said Pulse Biosciences remains on track to begin an FDA investigational device exemption study this year.
“[We] look forward to continuing our work with thought-leading physicians to achieve commercial approval and deliver this technology to more patients and providers,” LaViolette said.
Investigators presented results from the first-in-human feasibility study at the 30th Annual AFib Symposium 2025 meeting in Boston. The study aimed to assess the initial safety and efficacy of the pulsed field ablation (PFA) system for treating AFib.
Hayward, California–based Pulse Biosciences’ technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology. It features a percutaneous electrode system, which the FDA cleared earlier this year. It enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
A look at the outcomes presented by Pulse Biosciences
To date, six investigators have treated 77 patients at Na Holmolce Hospital in Prague and Jessa Hospital in Hasselt (Belgium). The study evaluated the initial 30-patient cohort with remapping completed at around three months post-ablation.
“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 Dr. Vivek Reddy, director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital. “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.”
In the study, investigators reported that all (100%) lesions were acutely successful with conduction block. They reported a success rate of pulmonary vein isolation (PVI) at three months of 92.4%. Total PVI ablation time came in at 11.6±4.5 minutes. The total procedure and fluoroscopy times registered at 88.3±30.1 and 6.9±2.4 minutes, respectively. Procedures had a left atrial dwell time of 29.6±15.3 minutes.
Investigators reported one primary serious adverse event (cardiac perforation). They shared two adverse events, including vertigo (managed conservatively) and creatinine elevation, treated with IV saline. The investigators resolved all adverse events 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,” said LaViolette.
