Pulse Biosciences, a company specializing in nanosecond Pulsed Field Ablation (nsPFA) technology, has received approval from the U.S. Food and Drug Administration (FDA) to begin a new study for its nsPFA Cardiac Surgery System. This Investigational Device Exemption (IDE) approval allows the company to initiate the NANOCLAMP AF study, a single-arm, prospective trial designed to demonstrate the effectiveness of its system for treating atrial fibrillation (AF) during concomitant surgical procedures. The study aims to enroll up to 136 patients across as many as twenty sites, including two outside of the United States.

The company's nsPFA Cardiac Clamp is a bipolar device that uses a proprietary nonthermal mechanism to create continuous, linear, and transmural ablations. Unlike traditional thermal methods, such as radiofrequency ablation, nsPFA energy minimizes the risk of collateral tissue damage, offering what the company believes are significant safety, effectiveness, and speed advantages. This technology received FDA Breakthrough Device Designation in July 2024. The FDA approval of the study is considered a major milestone for Pulse Biosciences, making it the first company to advance PFA into the cardiac surgical field for AF treatment.

The company has already been gathering promising first-in-human feasibility data from an ongoing study in the EU, which began in August 2024. Surgeons in that study have reported achieving rapid, consistent, and durable lesions in as little as 2.5 seconds. These early results have built confidence in the technology and its potential for broader global adoption. The company is poised to present some of this data at an upcoming European conference. By offering a faster and safer alternative to conventional thermal ablation devices, Pulse Biosciences hopes its technology will increase the overall adoption of surgical cardiac ablation for atrial fibrillation, ultimately improving the quality of life for patients.