Pulse Biosciences Enrolls First Patient in NANOCLAMP PFA Trial
Pulse Biosciences (Nasdaq:PLSE) 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, allowing the initiation of the NANOCLAMP AF study.
The NANOCLAMP AF study evaluates the company’s nanosecond PFA (nsPFA) Cardiac Surgery System for treating AFib. The first successful procedure was completed in Helena, California.
The company plans to enroll patients across multiple sites, including two outside the U.S., with Matthew Romano, a professor of cardiac surgery at the University of Michigan, serving 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."
Author's summary: Pulse Biosciences starts NANOCLAMP PFA trial.
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