Pulse Biosciences announced that the first patients were enrolled in its NANOPULSE-AF investigational device exemption (IDE) pivotal trial evaluating the nPulse cardiac catheter system to treat recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AFib).

The study’s first seven patients were treated at St. Bernards Medical Center in Jonesboro, Arkansas under Devi Nair, MD’s leadership. Dr. Nair is the principal investigator of the medical center’s Arrhythmia Research Group.

Dr. Nair said nPulse was paired with Abbott’s investigational Ensite X catheter mapping software for an efficient, reproducible, and streamlined workflow.

“This approach may potentially offer important advantages compared with existing technologies,” Dr. Nair told the press. “I look forward to continued enrollment and further clinical evaluation of this strategy in atrial fibrillation ablation for the betterment of all involved.”

The nPulse cardiac catheter system delivers energy for pulsed field ablation (PFA) in nanoseconds, whereas conventional systems deliver in the microseconds. nPulse’s non-thermal energy was engineered for precise, durable pulmonary vein isolation (PVI) and minimizing impact to nearby cardiac structures.

Pulse Biosciences’ first-in-human feasibility study of nPulse demonstrated 96% procedural success at 12 months and 100% acute success. The company said this exceeds expectations in a field where 20-25% is typical. It also noted reproducible outcomes across operators, without anti-arrhythmic drugs.

Pulse Bio exec and NANOPULSE-AF trial leader comments

“I am excited to initiate our IDE study with Dr. Nair, a leader in the EP ablation space. This marks an important advancing next step in the clinical development of our nanosecond PFA platform,” said David Kenigsberg, MD, FACC, FHRS, chief medical officer of Pulse Biosciences. “Building on encouraging first-in-human data demonstrating safety, procedural efficiency, durable pulmonary vein isolation, and ease of use, our catheter is now tightly integrated with the Abbott EnSite X 3D electroanatomical mapping system, enabling accurate catheter visualization, navigation and contact assessment to support optimal PFA delivery. We look forward to rigorously evaluating this technology in this larger, multicenter setting at up to 30 centers in the United States and Europe.”

“From the initial clinical experience, the nPulse system demonstrated meaningful potential in the treatment of atrial fibrillation,” said Dr. Vivek Reddy, director of cardiac arrhythmia services at the Mount Sinai Fuster Heart Hospital, N.Y. and principal investigator of the NANOPULSE-AF trial. “The NANOPULSE‑AF pivotal trial represents an important step forward in evaluating this technology and its potential role in improving procedural outcomes for patients with atrial fibrillation.”