Pulse Biosciences, Inc., a company that’s leading the way with its nPulse technology based on its own Nanosecond Pulsed Field Ablation (nsPFA) energy, has announced that it has enrolled the first patient in its key NANOCLAMP AF study for treating atrial fibrillation (AF). The first procedure was successfully done at St. Helena Hospital in St. Helena, California, using the nPulse Cardiac Surgical System after getting approval from the U.S. Food and Drug Administration (FDA) under an IDE clearance. NANOCLAMP AF is a single-arm, forward-looking, multi-site trial meant to check how safe and effective the nPulse Cardiac Surgical System is when used during other surgeries for AF. It is expected to involve multiple U.S. sites and two international ones.

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“After many years of development, it’s an honor to do the first NANOCLAMP AF surgery in the U.S. for AF using nanosecond PFA with Dr. Aaron Kime and the team at Adventist Health,” said Dr. Gan Dunnington, a Cardiothoracic Surgeon at Adventist Health. “I’m excited for my fellow surgeons to try this technology as we work to give patients with AF faster, safer, and more effective treatment options. Even though I saw this tech in Europe, my team was really impressed by how easy the nPulse Cardiac Clamp is to use and how fast the treatment was.”

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Dr. Matthew Romano, the National Principal Investigator and Professor of Cardiac Surgery at the University of Michigan, said, “This trial is a big step in our mission to improve patient care. nPulse technology has the potential to change how we do concomitant ablation procedures. This device has a better safety profile because it works without heat, and it can create consistent, precise, and lasting full-thickness lesions in much less time than existing methods.”

The nPulse Cardiac Surgical System is a newer, bipolar surgical tool made to create continuous full-thickness ablation lines during heart surgeries. Since it uses a non-thermal energy method, it’s expected to be much safer and more efficient than traditional thermal ablation techniques. The nsPFA Cardiac Surgical System was given Breakthrough Device Designation by the FDA in July 2024 and is part of the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP).

“Treating our first patient so quickly after getting IDE approval shows how excited cardiovascular surgeons are about nanosecond PFA,” said Dr. Niv Ad, Chief Scientific Officer, Cardiac Surgery at Pulse Biosciences. “Showing the benefits of nsPFA in this study could lead to a lot more use of surgical cardiac ablation in the future. We’re thankful to all the clinicians who keep supporting our clinical work. Together, we’re well-placed to raise the standard of care for AF and get this treatment to more patients who need it.”

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