FDA Grants Breakthrough Device Designation to Cardiac Surgery System for Treatment of Atrial Fibrillation

A cardiac surgery system (CellFX nsPFA; Pulse Biosciences, Inc) in combination with the bipolar clamp received breakthrough device designation from the FDA for the ablation of cardiac tissue in treatment of patients with atrial fibrillation (AF). The decision was based on preclinical trial results demonstrating the devices’ capabilities in providing consistent, transmural ablation, requiring one-twentieth the time of thermal ablation technologies in a single application of less than 2 seconds. This advancement of short-duration, high-amplitude energy pulses with a nonthermal mechanism of action offers patients a safer, more effective treatment that limits damage to tissue outside of the heart.

The cardiac surgery system in combination with the surgical clamp is designed to produce continuous transmural ablation lesions during cardiac surgery using nanosecond PFA technology for patients with AF. Image Credit: ©Oporty786 - stock.adobe.com

AF is the most common type of heart arrhythmia, resulting in irregular beating in the atria of the heart, impacting blood flow to its lower chambers. The discoordination of the upper and lower chambers of the heart can cause it to beat too quickly, too slowly, or irregularly, resulting in heart palpitations, fatigue, chest pain, shortness of breath, and lightheadedness. The risk of developing AF increases with age, and other risk factors include high blood pressure, obesity, smoking, European ancestry, diabetes, or heart disease. Additionally, AF increases the risk of ischemic stroke by 5-fold.¹

Standard-of-care treatment for patients with AF typically include medicines to control heart rate, blood thinners to prevent blood clots, surgery, lifestyle modifications, and thermal ablation. Thermal ablation is a minimally invasive procedure using heat to create scars on the inside of the heart, helping to insulate the electrical signals that cause the irregular heartbeat. However, growing research into pulsed field ablation (PFA) technology and the approval of the cardiac surgery system offer patients more effective treatment that limits damage to tissues outside the heart.^1,2

The success of PFA technology has been investigated in multiple studies. For example, in one randomized, single-blind, noninferiority trial (NCT04612244), the results of which were published in the New England Journal of Medicine, 305 patients were assigned to undergo PFA and 302 were assigned thermal ablation. At 1 year, the primary efficacy end point was met in 204 patients receiving PFA treatment compared with the 194 patients who underwent thermal ablation (between-group difference, 2.0 percentage points; 95% Bayesian credible interval, −5.2 to 9.2; posterior probability of noninferiority, >.999), demonstrating the noninferiority of PFA technology compared with thermal ablation.²

The cardiac surgery system in combination with the surgical clamp is designed to produce continuous transmural ablation lesions during cardiac surgery using nanosecond PFA technology for patients with AF. The FDA breakthrough device designation underscores the success of the treatment and is intended to accelerate development to provide patients and clinicians with timely access to alternative treatments. Clinical trials investigating the devices for the treatment of patients with AF are set to begin in 2025.³

“The preclinical results we have generated with the Cardiac Surgery System have been outstanding and I expect to see similar results in the initial clinical procedures in the Netherlands later this year,” said Gan Dunnington, MD, chief medical officer, cardiac surgery of Pulse Biosciences, in a press release. “Nanosecond PFA has the potential to be a revolutionary advancement for the surgical treatment of atrial fibrillation.”³

REFERENCES

1. About Atrial Fibrillation. CDC. May 14, 2024. Accessed July 8, 2024. https://www.cdc.gov/heart-disease/about/atrial-fibrillation.html
2. Reddy V, Gerstenfeld E, Natale A, et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. August 27, 2023. doi:10.1056/NEJMoa2307291
3. Pulse biosciences, inc. announces receipt of fda breakthrough device designation for cellfx® nspfa cardiac surgery system for the treatment of atrial fibrillation. News Release. July 8, 2024. Accessed July 8, 2024. https://www.businesswire.com/news/home/20240708028800/en/Pulse-Biosciences-Inc.-Announces-Receipt-of-FDA-Breakthrough-Device-Designation-for-CellFX%C2%AE-nsPFA-Cardiac-Surgery-System-for-the-Treatment-of-Atrial-Fibrillation