Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted investigational device exemption (IDE) for its nanosecond pulsed field ablation (nsPFA) system.
The approval allows Pulse to proceed with the initiation of the NANOCLAMP AF study. NANOCLAMP AF evaluates the company’s nanosecond PFA (nsPFA) Cardiac Surgery System for treating AFib.
According to a news release, the company aims for the study to demonstrate the primary effectiveness of nsPFA for AFib in concomitant surgical procedures. The study features up to 20 sites, including two outside the U.S., with plans to enroll up to 136 patients.
Hayward, California-based Pulse designed its system to deliver continuous, linear, transmural ablations during concomitant cardiac surgeries. Its bipolar device leverages nonthermal nsPFA technology designed to minimize the risk of collateral tissue damage. The system received FDA breakthrough device designation last year.
Pulse’s nsPFA system features a cardiac clamp meant to provide a replacement for conventional radiofrequency ablation devices. It can potentially deliver a faster, more consistent and safer approach to surgical cardiac ablation. The company said it can achieve full thickness, contiguous, durable lesions with educed ablation times.
“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.
LaViolette discussed Pulse Biosciences nsPFA tech with Medical Design & Outsourcing earlier this year: Is nanosecond pulsed field ablation the next big step for PFA?
