Pulse Biosciences (Nasdaq:PLSE) today announced the enrollment of the first patient in its NANOCLAMP AF study for treating AFib.
In September, the FDA granted investigational device exemption (IDE) for Pulse’s nanosecond pulsed field ablation (nsPFA) system. Approval gave Pulse the green light 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.
Doctors at St. Helena Hospital in St. Helena, California, completed the first successful procedure in the study. The company plans to enroll patients across multiple sites, including two outside the U.S.
Dr. Matthew Romano, a professor of cardiac surgery at the University of Michigan, serves as national principal investigator.
“This trial marks a pivotal moment in our journey to transform patient care,” said Romano. “nPulse technology has the potential to revolutionize how we approach concomitant ablation procedures.”
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.
“Treating our first patient so quickly following the IDE approval demonstrates the excitement about nanosecond PFA among cardiovascular surgeons,” said Dr. Niv Ad, chief scientific officer, Cardiac Surgery at Pulse Biosciences. “Proving the benefits of nsPFA in this study could drive significant future adoption of surgical cardiac ablation. We are grateful to all the clinicians who continue to support our clinical work. Together we are poised to advance the standard of care for AF and increase the number of patients being treated.”
