Pulse Biosciences announced that its nPulse Cardiac Catheter achieved a 100% procedural success rate at six months in a first‑in‑human feasibility study involving 150 patients with atrial fibrillation. The study, presented at the 31st Annual AF Symposium in Boston, Massachusetts, also reported a 96% success rate at 12 months, underscoring the durability of the nanosecond pulsed‑field ablation (nsPFA) technology.
The feasibility trial averaged 16.1 applications per procedure, with a total procedure time of 65 minutes and a fluoroscopy time of 9.8 minutes. Left atrial dwell time averaged 21.0 minutes, and the safety profile was strong, with only 1.3% (two out of 150) of subjects experiencing a serious adverse event related to the primary safety endpoint.
Chief Medical Officer Dr. David Kenigsberg highlighted that the nsPFA platform delivers lower total energy and reduced collateral injury compared to microsecond PFA systems, positioning the nPulse Cardiac Catheter as a first‑in‑class solution for pulmonary vein isolation. CEO Paul LaViolette emphasized that the data validate the system’s workflow efficiency and safety, suggesting a potential market advantage over existing radiofrequency and PFA devices.
The results support Pulse Biosciences’ regulatory strategy, providing pivotal evidence that will inform the upcoming NANOPULSE‑AF pivotal study and future FDA pre‑market approval submissions. The company’s FDA Investigational Device Exemption approval for the study demonstrates regulatory confidence in the technology’s clinical promise.
These findings reinforce Pulse Biosciences’ competitive differentiation in the atrial fibrillation market, where high recurrence rates and procedural complexity remain challenges. By offering a non‑thermal, rapid‑ablation platform with a simplified workflow, the company aims to capture market share from both traditional ablation modalities and emerging PFA competitors.
The announcement is expected to strengthen investor confidence in Pulse Biosciences’ clinical pipeline and regulatory trajectory, potentially influencing future capital allocation and partnership opportunities.
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