January 8,According to the latest news from Reuters, Johnson & Johnson Medical Technologies announced that it will suspend the use of its newly launched Varipulse pulsed field ablation system in the United States due to four reported neurovascular events during an external evaluation. The company has decided to proceed with caution and will investigate the root cause of these neurovascular events.

Varipulse Pulsed Field Ablation System Receives FDA Approval in November 2024 for Treating Patients with Drug-Refractory, Symptomatic Paroxysmal Atrial FibrillationThe system achieved positive results in the pivotal "admIRE" trial, providing strong support for FDA approval. However, the occurrence of two strokes and one transient ischemic attack during the trial raised concerns among commentators at the time, being considered a "somewhat worrisome" phenomenon.

Johnson & Johnson stated that the decision to suspend the use of the Varipulse system was based on an in-depth investigation into four neurovascular events reported in external evaluations. Although the specific causes of these events have not been determined, Johnson & Johnson believes it is necessary to take precautionary measures to ensure patient safety. A spokesperson for Johnson & Johnson noted that the Varipulse system used in the U.S. external evaluation study "utilized a unique platform configuration," and therefore would not impact commercial activities or treatment cases outside the United States.

Since receiving FDA approval, the Varipulse system has completed over 3,000 commercial cases worldwide. However, in the United States, the system remains in the external evaluation phase, a limited release aimed at gathering physician feedback on the new technology before a broader full launch. As of January 3, 2025, 40 surgeons across 14 centers have used the Varipulse system to treat more than 130 cases.

Johnson & Johnson added that they are working hard to complete the investigation in accordance with medical safety procedures and resume external evaluations in the United States as soon as possible. More information is expected to be communicated in the coming days. However, it remains unclear how long the sales of Varipulse will be suspended. Even if Johnson & Johnson allows the resumption of sales, electrophysiologists may remain cautious about Varipulse. In contrast, if Boston Scientific (BS) and Medtronic’s pulsed ablation systems do not encounter similar issues, they may benefit.

In the field of pulsed field ablation (PFA), Medtronic, Boston Scientific, and Johnson & Johnson have all received FDA approval for market release. Medtronic's PulseSelect system became the first PFA system to gain FDA approval for treating paroxysmal atrial fibrillation and persistent atrial fibrillation in December 2023. The system uses a circular ablation catheter that delivers bipolar, biphasic pulsed electric fields through a circular multi-electrode array catheter and can be used with any mapping system.

Boston Scientific's Farapulse system was successfully approved in January 2024 for the treatment of paroxysmal atrial fibrillation. In October of the same year, Boston Scientific received approval for the launch of the Farawave Nav system, an upgraded version of the Farapulse system and the first PFA catheter with integrated mapping to enter the U.S. market. The Farawave catheter features a flower-shaped design with five "petals," each equipped with four electrodes. Its user interface is simple, allowing pulmonary vein vestibule isolation through just three buttons.

Johnson & Johnson's Varipulse system is a newly approved pulsed field ablation product in November 2024 and has not yet been launched in China.This system integrates the CARTO™ mapping system, capable of simultaneously using magnetic and electric fields to map and locate intracardiac electrical signals, and directly displaying the intracardiac anatomical structure in three dimensions. The VARIPULSE ablation catheter builds on Johnson & Johnson's LASSO catheter technology, featuring a circular tip with 10 electrodes, and the size of the circular tip can be adjusted; the catheter allows for bidirectional bending (180° on one side and 90° on the other), making it suitable for use in all four pulmonary veins.

Analysts pointed out that Johnson & Johnson's suspension of the sale of the Varipulse system could adversely affect its market position. If Boston Scientific and Medtronic’s pulsed field ablation systems do not encounter similar issues, they are expected to benefit. Boston Scientific stated last month that it anticipates PFA will account for 40% to 60% of atrial fibrillation ablation procedures globally by around 2026.

Yesterday, Johnson & Johnson Medical's stock price fell by 2.71%, hitting a three-year low of $141.44. Competitors Boston Scientific Corporation and Medtronic rose by 5% and 4%, respectively.

Atrial fibrillation is one of the most common arrhythmias, affecting the health of tens of millions of people worldwide. According to Frost & Sullivan analysis, the size of China's PFA market is expected to expand to 16.3 billion yuan by 2032, with a compound annual growth rate (CAGR) as high as 43.73% during this period.

Under the current tripartite standoff in the PFA market, Johnson & Johnson's suspension of Varipulse system sales in the U.S. will undoubtedly trigger changes in the market landscape, and Medical Device News will continue to monitor the situation.

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