Pulse Biosciences Inc. (NASDAQ: PLSE) has enrolled the first patients in its NANOPULSE-AF pivotal clinical study, which is evaluating the company's nPulse Cardiac Catheter System for treating drug-resistant paroxysmal atrial fibrillation.

The first seven patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Dr. Devi Nair, Principal Investigator of the Arrhythmia Research Group. The study is a prospective, multicenter investigation that plans to enroll approximately 215 participants across up to 30 centers in the United States and Europe.

The enrollment follows results from Pulse Biosciences' European feasibility study, which showed 96% procedural success at 12 months and 100% acute success. The company reported these outcomes were achieved without anti-arrhythmic drugs and were reproducible across operators.

The nPulse system delivers nanosecond pulsed field ablation energy, which the company states operates in billionths of a second compared to conventional microsecond-based systems. The catheter is integrated with Abbott's EnSite X 3D electroanatomical mapping system for visualization and navigation.

Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital, serves as Principal Investigator of the NANOPULSE-AF Study. The study's primary endpoints will be assessed at 6 and 12 months post-ablation to measure procedural success and safety outcomes.

According to the company's previous feasibility study, the system achieved a median left atrial dwell time of 21 minutes and total procedure time of approximately 65 minutes. The technology is designed to create pulmonary vein isolation while minimizing impact to surrounding cardiac structures.