Pulse Biosciences has announced the treatment of the first two patients in a first-in-human (FIH) feasibility study using its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology-based Cardiac Surgery System.
Cardiac Surgery System employs the nsPFA technology to ablate cardiac tissue in the treatment of atrial fibrillation.
The patients with atrial fibrillation were treated at St. Antonius Hospital, Nieuwegein, The Netherlands.
The first-in-human feasibility study is a multi-centre trial involving up to 30 patients.
It will feature the use of an endocardial catheter-based approach to assess the effectiveness of the novel Cardiac Surgery System.
Pulse’s Cardiac Surgery System, featuring a Surgical Clamp, is engineered to create durable, continuous, and transmural ablation lesions during cardiac surgery for atrial fibrillation treatment.
The bipolar clamp employs the company’s proprietary nanosecond PFA technology.
According to pre-clinical studies, a single application lasting under two seconds with the Surgical Clamp produces consistent, transmural, and durable ablation, Florida-based Pulse Biosciences said.
According to the bioelectric medicine company, the process is significantly faster compared to existing thermal ablation technologies.
Additionally, the presence of nano-PFA’s non-thermal mechanism excludes the risk of thermal spread that might cause unintended damage to surrounding tissues, offering an advantage over thermal radiofrequency ablation.
Pulse Biosciences president and CEO Burke Barrett said: “We continue to make great strides on the development of our current nano-PFA devices, three of which have now been used in patients with initial promising results.
“We are grateful for all the key opinion leader clinicians who have partnered with us to advance nano-PFA technology for the benefit of patients and clinicians worldwide.”
In early July 2024, the nano-PFA Cardiac Surgical System received US Food and Drug Administration (FDA) Breakthrough Device Designation.
It has since been enrolled in the FDA’s TAP (Total Product Lifecycle Approach) programme, which intends to develop safe medical devices essential to public health.
The bioelectric medicine firm aims to seek FDA premarket approval (PMA) to bring its nano-PFA Cardiac Surgical System to the US market for treating atrial fibrillation.
Pulse Biosciences plans to start its clinical study for the nano-PFA Cardiac Surgical System in early 2025 and will share more details about the study, along with its regulatory and commercial impacts, later this year.
