Johnson & Johnson's Pulsed Field Ablation System Receives CE Mark; Domestic Electrophysiology Leaders Poised for Breakthrough

Industry Events

Johnson & Johnson's Pulsed Field Ablation Product Receives European CE Mark Approval. On February 29, 2024, Johnson & Johnson Medical announced that its pulsed field ablation product, "VARIPULSE?," received European CE Mark approval for the treatment of symptomatic drug-refractory recurrent paroxysmal atrial fibrillation. The company’s VARIPULSE? platform consists of the VARIPULSE? catheter (a variable loop multi-electrode catheter), the TRUPULSE? multi-channel signal generator, and Johnson & Johnson's CARTO? 3 three-dimensional electrophysiology navigation system. Previously, on January 9, 2024, Johnson & Johnson's pulsed field ablation product, "VARIPULSE?," was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for marketing, applicable for treating symptomatic drug-refractory recurrent paroxysmal atrial fibrillation, marking the first PFA product approved in Japan.

Extended Information

Pulsed Field Ablation (PFA) is based on the principle of irreversible electroporation (IRE). Pulsed field ablation applies high-voltage pulses ranging from microseconds to nanoseconds to the target tissue, instantly creating irreversible electroporation (IRE) in the phospholipid bilayer of the cell membrane. This increases ion transport, destabilizes the permeability of the cytoplasmic membrane, and ultimately induces cell death while blocking abnormal electrical conduction, thereby restoring the patient's heart rhythm and achieving therapeutic effects for tachyarrhythmia.

Pulsed Field Ablation Offers Superior Safety Advantages. In terms of procedural safety, compared to radiofrequency ablation and cryoablation, pulsed field ablation demonstrates tissue selectivity. The main principle is that the threshold of pulsed electric field strength required to induce cell death varies across different types of human tissue. Cardiac muscle cells have the lowest ablation threshold among their surrounding tissues. Therefore, by setting the pulsed electric field strength within a specific range, it can selectively ablate cardiac muscle tissue while avoiding damage to adjacent structures such as blood vessels, nerves, muscles, and mucosa outside the heart. Additionally, since pulsed field ablation is a non-thermal ablation method, it does not cause heat-related injuries, offering enhanced safety advantages.

Pulsed Field Ablation Demonstrates Strong Efficacy. According to research findings published by Kuroki K et al. in 2020 in *Heart Rhythm*, in pulmonary vein isolation procedures, pulsed field ablation significantly reduces the incidence of postoperative pulmonary vein stenosis compared to radiofrequency ablation. In terms of procedural efficacy, multiple scientific studies have shown that PFA technology achieves a high success rate in treating tachyarrhythmias. Reddy et al. were the first to apply pulsed field ablation technology in human atrial fibrillation treatment in 2018. Using bipolar PFA with a monophasic waveform during pulmonary vein isolation, they achieved a 100% acute pulmonary vein isolation rate without serious complications, demonstrating the strong efficacy of pulsed field ablation.

Pulsed Field Ablation and Conventional Catheter Ablation Show Similar Success Rates in Single-Procedure, Drug-Free Treatment, Meeting Non-Inferiority Standards. At the 2023 European Society of Cardiology Congress (ESC2023), Professor Vivek Reddy, principal investigator from the Icahn School of Medicine at Mount Sinai in New York, USA, presented the main results of the ADVENT study: In treating paroxysmal atrial fibrillation (AF), pulsed field ablation (PFA) demonstrates similar efficacy and safety compared to conventional catheter ablation (radiofrequency or cryoablation). There was no statistically significant difference between the PFA group and the conventional catheter ablation group in immediate success rates of pulmonary vein isolation (99.6% vs. 99.8%, respectively). Compared with the conventional catheter ablation group, the PFA group had shorter procedure times, left atrial dwell times (total time the ablation catheter remained in the left atrium), and ablation times (cumulative time from the first to the last ablation); however, the fluoroscopy time was longer in the PFA group (approximately 7 minutes more). Regarding the primary effectiveness endpoint: After one year of follow-up, the rate of effectiveness endpoint occurrence was 73% in the PFA group and 71% in the conventional catheter ablation group (69.2% for radiofrequency and 73.6% for cryoablation). The single-procedure, drug-free treatment success rates were comparable between pulsed field ablation and conventional catheter ablation, meeting non-inferiority standards but not reaching superiority criteria.

Currently, in China, only the products of Jinjiang Electronics have received approval from the National Medical Products Administration (NMPA) for market release. On December 7, 2023, the Pulse Field Ablation System developed by Jinjiang Electronics was approved by the NMPA, marking it as the first PFA product in China to receive such an approval. Through over 200 animal experiments, Jinjiang Electronics' LEAD PFA system has demonstrated its safety, efficacy, and reliability. Additionally, clinical trials involving more than 300 doctors have shown that the PFA ablation system, when used with a 3D mapping system, exhibits certain advantages. By the end of 2023, Jinjiang Electronics’ PFA ablation system had been implemented in over 30 hospitals, with more than 40 physicians utilizing the system to perform over 340 electrophysiology procedures.

Currently, several electrophysiology companies in China have also developed products related to cardiac pulsed field ablation. Among them, Denuo Electrophysiology entered the special review process in May 2022. The PFA clinical trials of Huitai Medical and MicroElectroPhysiology have completed patient enrollment and are currently in the follow-up stage. The PFA products from imported brands Medtronic and Boston Scientific have also now entered the special review process.

Investment Advice

We expect the peak commercialization period for PFA products in China's cardiac electrophysiology market to be around 2025. Domestic and imported brands are relatively on an equal footing in PFA technology. Leading domestic brands are expected to gain an advantage in the Chinese PFA market by leveraging local or first-mover advantages, further narrowing the gap with overseas electrophysiology giants and achieving a competitive leapfrog.

It is recommended to focus on: MicroEP, Huitai Medical

Risk Warning:

Product development fell short of expectations, and commercialization progress was slower than expected.