Procedural success was achieved in 100% of evaluable patients at 6 months and 96% in 12 months
Pulse Biosciences, the company behind the innovative nPulse technology that uses proprietary Nanosecond Pulsed Field Ablation energy, shared new clinical results from the first-in-human feasibility study of its nPulse Cardiac Catheter. The study evaluated the catheter’s ability to treat atrial fibrillation in 150 patients and showed rapid procedure times with minimal adverse events. These findings were presented at the 31st Annual AF Symposium 2026, held February 5-7 in Boston, Massachusetts.
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Key results from the study indicate a 100 percent procedural success rate at six months among evaluable patients and a 96 percent success rate at one year. On average, each procedure required 16.1 applications, with total procedure and fluoroscopy times averaging 65 and 9.8 minutes, respectively. The left atrial dwell time averaged 21 minutes. Only 1.3 percent of patients experienced a serious adverse event related to the primary safety endpoint.
“These six- and twelve-month outcomes show that the nPulse Cardiac Catheter delivers highly effective and durable pulmonary vein isolation while maintaining a strong safety profile,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital in New York. “Its conformable design, unique energy delivery, and simple workflow allowed us to achieve efficient results that compare favorably to other AF studies I have been involved in. The system’s design makes complex procedures more straightforward and effective.”
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The feasibility study is ongoing and aims to assess the initial safety and effectiveness of the nPulse Cardiac Catheter System for atrial fibrillation. A total of 165 patients have been treated to date by nine investigators across Europe, including Dr. Reddy and Prof. Petr Neuzil at Na Homolce Hospital in Prague, Dr. Johan Vijgen at Jessa Hospital in Hasselt, and Dr. Andrea Natale at Tor Vergata Hospital in Rome. Patients in the initial cohort have undergone remapping at approximately three months and rhythm control evaluations at six and twelve months after the ablation procedure.
“This set of data represents a significant milestone for Pulse Biosciences, highlighting the combination of improved workflow, safety, and effectiveness,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “The results confirm the advantages of the nPulse Cardiac Catheter Ablation System in terms of lesion quality, speed, and overall procedural outcomes. We are grateful to the clinicians, staff, and patients who have contributed to this study.”
Dr. David Kenigsberg, Chief Medical Officer of Electrophysiology at Pulse Biosciences, added, “The nPulse Cardiac Catheter has shown first-in-class performance for treating AF. In a field where recurrence rates of 20 to 25 percent are expected, these results surpass what we typically see. The integration of nanosecond PFA energy with a 3D mapping system allows for precise and durable pulmonary vein isolation. We are excited to expand patient enrollment in Europe and the U.S. as we move into the pivotal IDE study.”
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