Pulse Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) for its nanosecond pulsed field ablation (nsPFA) system.
This approval enables the company to launch the NANOCLAMP AF study, which will evaluate the effectiveness of the nsPFA Cardiac Surgery System for treating atrial fibrillation (AFib) during concomitant surgical procedures. The multi-center trial plans to enroll up to 136 patients across as many as 20 sites, including two international locations.
Based in Hayward, California, Pulse designed its nsPFA technology to deliver continuous, linear, transmural ablations during cardiac surgery. Unlike conventional radiofrequency ablation, the nonthermal nsPFA approach is engineered to minimize collateral tissue damage while creating durable, full-thickness lesions with reduced ablation times.
The FDA had previously awarded the system Breakthrough Device Designation. Its cardiac clamp aims to provide a safer, faster, and more consistent alternative to standard surgical ablation methods.
“This FDA IDE approval is a major milestone for Pulse Biosciences. The study approval is a testament to the quality of the preclinical and human clinical data that has been generated in support of this breakthrough technology. Pulse Biosciences is the first company to advance PFA into the cardiac surgical field for the treatment of AFib,” said Paul LaViolette, co-chair and CEO of Pulse Biosciences.