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.