Pulse Biosciences has revealed late-breaking study data from its nPulse Cardiac Surgical System first-in-human feasibility study. The results were presented at the 39th European Association for Cardio-Thoracic Surgery annual meeting.

The study is evaluating nPulse nanosecond pulsed field ablation (nanosecond PFA or nsPFA) to treat atrial fibrillation (AFib)—to date, 44 patients have been treated by European investigators. The researchers include Dr. Bart van Putte in cases performed at St. Antonius Hospital Nieuwegein, Netherlands, Dr. Bart Maesen performing cases at Maastricht UMC+, Maastricht, Netherlands, and Dr. Antoine Driessen performing cases at Amsterdam UMC, Amsterdam, Netherlands.

24 patients in this first cohort had ablation effectiveness and durability assessed with electroanatomical mapping at about three months after the ablation procedure.

Dr. Putte, a cardiothoracic surgeon at St. Antonius Hosital in Nieuwegein, Netherlands said the electroanatomical mapping for those first patients treated with nPulse showed durable, consistent pulmonary vein isolation (PVI). He said he was able to achieve PVI safely, with quick ablation times.

“This feasibility study represents the first use of an epicardial PFA surgical technology, and the early results suggest the speed, safety and effectiveness of the nPulse Surgical Cardiac Clamp’s efficient workflow has the potential to significantly expand the use of cardiac surgical ablation for patients suffering from atrial fibrillation,” Dr. Putte told the press.

Study Results

• All posterior box isolations were successful in the high-dose cohort
• 94% success rate of PVI per vein at three months
• 50 second average total ablation time with 13 average applications
• No reports of esophageal or phrenic nerve damage
• No ablation-related severe or major adverse events

Pulse Biosciences co-chairman and CEO Paul LaViolette said the company is on track to begin its NANOCLAMP AF investigational device exemption (IDE) study this year to validate nPulse. LaViolette said the company looks forward to working with leading physicians to gain marketing authorization and expand patient access.

“Pulse Biosciences is the first company to bring PFA into the cardiac surgical field for the treatment of atrial fibrillation,” he told the press. “We believe our novel and proprietary nonthermal nPulse technology offers significant advantages in safety, as demonstrated across our multiple clinical applications, as well as efficacy, and speed compared to traditional thermal ablation methods like radiofrequency.