On January 8 local time, Johnson & Johnson announced on its official website the suspension of clinical use of the PFA product Varipulse, which was recently launched in the United States.It is reported that this decision was made after four cases of stroke were reported during external assessments following patient treatment.Varipulse is a pulsed field ablation device used to treat drug-refractory paroxysmal atrial fibrillation, which received approval from the U.S. Food and Drug Administration (FDA) in November 2024. The approval of this product has been regarded as one of the landmark development events in the PFA field in recent years.PFA in the medical field usually refers to Pulsed Field Ablation, a new ablation technology used to treat arrhythmias (such as atrial fibrillation). It restores normal heart rhythm by using pulsed electric fields to disrupt abnormal electrical signals in cardiac tissue.Compared with traditional radiofrequency ablation and cryoablation, PFA is considered to have better tissue selectivity and safety.Before 2018, PFA technology had not entered the mainstream vision of medical device companies until the publication of an explosive clinical trial result in the United States.
In this clinical trial, researchers performed PFA treatment on 15 patients undergoing endocardial ablation. The results showed an immediate success rate of 100%, with each patient's PFA procedure lasting less than 60 seconds, and no serious complications occurred.This groundbreaking research result laid the foundation for the application of PFA technology in the field of cardiac electrophysiological ablation and triggered a large number of subsequent clinical trials and research developments.Currently, among the global medical device giants, similar products from Boston Scientific and Medtronic have also been approved for marketing, in addition to Johnson & Johnson.
Among them, Boston Scientific's Farapluse was launched four years ago, with an estimated cumulative number of surgeries exceeding 100,000. Medtronic's PulseSelect was approved at the end of 2023, and the number of surgeries has already surpassed 30,000.Given that no strong correlation with stroke was observed in large patient populations for Boston Scientific and Medtronic products, the issue may lie in the design of Johnson & Johnson's own products.
But this also sounds a warning bell for the burgeoning PFA track:The safety of PFA technology is not as absolutely secure as imagined. If there are design defects in the product, the adverse consequences could be enormous.But this kind of "design defect" is obviously hidden and difficult to detect in advance. Even a global medical device giant like Johnson & Johnson can only discover it in large-scale clinical applications after the product is launched.This raises a crucial question for dozens of companies in China that are engaged in the development of PFA products: Is the safety of your product more aligned with Medtronic/Boston Scientific, or closer to Johnson & Johnson?
Currently, more than one PFA product has been approved for marketing in China.
On December 27, 2023, Jinjiang Electronics' Pulse Field Ablation System received market approval from the National Medical Products Administration (NMPA), becoming the first approved pulse field ablation product in China. The system consists of two parts: the LEAD-PFA Cardiac Pulse Field Ablation Device and a single-use cardiac pulse field ablation catheter.On March 11, 2024, Denuo Electrophysiology announced that its CardiPulse pulsed field ablation catheter received NMPA approval for marketing. This is the first petal/basket-shaped catheter to be marketed in China, capable of completing pulmonary vein isolation without relying on 3D technology.In addition, Johnson & Johnson's clinical trial suspension of this productThe PFA product Varipulse has submitted an application for market approval in China, but it has not yet been officially approved.Pharmaceutical ResearchReportShare CampCollect and Share Mainstream Pharmaceutical Research Reports in the Entire Market
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