Pulse Biosciences has announced the successful completion of the first-in-human procedures using its new CellFX nsPFA cardiac catheter.
This marks a significant milestone in the company’s feasibility study for the treatment of atrial fibrillation.
The first five patients treated with this technology were discharged successfully and will be monitored to evaluate the safety and effectiveness of the treatment, with a primary safety endpoint at 30 days.
Mount Sinai Hospital’s cardiac arrhythmia services director Dr Vivek Reddy and Na Homolce Hospital cardiology chief Dr Petr Neuzil, along with their colleagues, have successfully used the CellFX nsPFA 360 cardiac catheter on five patients at Na Homolce Hospital in Prague.
The catheter was integrated with 3D mapping and navigation technologies such as iMap System and CardioNXT for treating the patients.
Dr Reddy said: “We have been collaborating with Pulse Biosciences to bring their novel nsPFA technology to the clinical realm, and are excited to report that our experience with these first five patients has validated our belief that this may represent the next generation of PFA technology for the treatment of AF.
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“The results were consistent with our preclinical experience. Importantly, the speed and ease with which we were able to isolate the pulmonary veins with the nsPFA 360 catheter was impressive and all patients tolerated the procedure well.”
The company plans to enrol up to 30 patients in the feasibility study, with regular evaluations to further assess the treatment’s safety and efficacy.
Pulse Biosciences is committed to keeping stakeholders informed, especially if results deviate materially from expectations. While initial observations are positive, the inherent risks of cardiac surgery are still present.
The company is preparing to initiate the regulatory process with the US FDA and other global authorities, anticipating that additional studies will be required.
The CellFX nsPFA 360 cardiac catheter is designed for nonthermal ablation, specifically targeting pulmonary vein isolation. It is currently under investigation and aims to deliver a fast, transmural, and fully circumferential ablation in a single energy delivery.
In October this year, Pulse Biosciences announced a collaboration with CardioNXT for the nsPFA cardiac catheter first-in-human study.
