HAYWARD, Calif. — Pulse Biosciences, Inc. (Nasdaq: PLSE), a medical technology company pioneering the use of its proprietary Nanosecond Pulsed Field Ablation (nsPFA) energy through the nPulse platform, announced the first patient enrollment in its NANOCLAMP AF Study for the treatment of atrial fibrillation during concomitant surgical procedures. The initial procedure was successfully performed at St. Helena Hospital in St. Helena, California, marking the first use of the nPulse Cardiac Surgical System in a U.S. clinical setting following recent FDA Investigational Device Exemption approval.
The NANOCLAMP AF Study is a single-arm, prospective, multicenter clinical trial designed to evaluate the safety and effectiveness of the nPulse Cardiac Surgical System for treating atrial fibrillation in patients undergoing other cardiac surgeries. Multiple sites, including two international locations, are planned for enrollment.
“After years of development, it is an honor to perform the first NANOCLAMP AF surgical procedure in the U.S. for the treatment of AF using nanosecond PFA with Dr. Aaron Kime and the team here at Adventist Health,” said Dr. Gan Dunnington, cardiothoracic surgeon for Adventist Health. “I’m excited for my fellow surgeon colleagues to experience this technology as we aim to bring faster, safer, and more effective treatment options to patients suffering from AF. While I have seen this technology used in the European clinical experience, my team was impressed by the nPulse Cardiac Clamp’s ease of use, and the speed of treatment exceeded their expectations.”
“This trial marks a pivotal moment in our journey to transform patient care,” said Dr. Matthew Romano, national principal investigator and professor of cardiac surgery at the University of Michigan. “nPulse technology has the potential to revolutionize how we approach concomitant ablation procedures. This device offers an improved safety profile as a result of the nonthermal mechanism of action while enabling consistent, precise, contiguous, and durable full-thickness lesions in a fraction of the time compared to existing technology. This should ultimately translate to improved outcomes for our patients and expand treatment to more people in need.”
The nPulse Cardiac Surgical System is a next-generation, bipolar surgical device engineered to create continuous, full-thickness ablation lines during concomitant cardiac procedures. By using a nonthermal energy modality, the system aims to reduce complications and improve procedural efficiency compared to traditional thermal ablation methods. The nsPFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and is participating in the FDA’s Total Product Life Cycle Advisory Program.
“Treating our first patient so quickly following the IDE approval demonstrates the excitement about nanosecond PFA among cardiovascular surgeons,” said Dr. Niv Ad, chief scientific officer for cardiac surgery at Pulse Biosciences. “Proving the benefits of nsPFA in this study could drive significant future adoption of surgical cardiac ablation. We are grateful to all the clinicians who continue to support our clinical work. Together we are poised to advance the standard of care for AF and increase the number of patients being treated.”
