Pulse Biosciences Begins Clinical Trial for Cardiac Catheter

Company enrolls first patients in pivotal study of nPulse device for atrial fibrillation treatment.

Apr. 7, 2026 at 12:36pm

An extreme close-up X-ray photograph showing the delicate internal components of a cardiac catheter device, revealing its intricate structure and conceptually representing its medical application.A cutting-edge cardiac catheter device designed to precisely target and ablate irregular heart tissue, offering new hope for patients struggling with atrial fibrillation.Hayward Today

Pulse Biosciences, a medical technology company, has enrolled the first patients in a pivotal clinical study evaluating its nPulse Cardiac Catheter for the treatment of atrial fibrillation. The NANOPULSE-AF IDE study will assess the safety and efficacy of the nPulse device, which uses nanosecond pulsed electric fields to ablate cardiac tissue.

Why it matters

Atrial fibrillation is a common heart rhythm disorder that can lead to serious complications if left untreated. The nPulse Cardiac Catheter represents a potential new treatment option that could improve outcomes for patients with this condition. The successful completion of this pivotal study could pave the way for regulatory approval and wider adoption of the device.

The details

The NANOPULSE-AF IDE study will enroll up to 400 patients at multiple clinical sites. The nPulse Cardiac Catheter is designed to deliver nanosecond pulsed electric fields to selectively ablate cardiac tissue and restore normal heart rhythm in patients with atrial fibrillation. This non-thermal ablation approach aims to minimize collateral damage to surrounding tissues compared to traditional radiofrequency or cryoablation techniques.

  • Pulse Biosciences enrolled the first patients in the NANOPULSE-AF IDE study on April 7, 2026.

The players

Pulse Biosciences

A medical technology company developing novel therapies for the treatment of various diseases and conditions.

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What’s next

The NANOPULSE-AF IDE study is expected to continue enrolling patients over the next 12-18 months, with topline results anticipated in 2028.

The takeaway

The initiation of this pivotal clinical trial for the nPulse Cardiac Catheter represents an important milestone in the development of a potentially groundbreaking new treatment for atrial fibrillation, a condition that affects millions of people worldwide.