November 7, 2024Johnson & Johnson's Varipulse Pulsed Field Ablation System Receives FDA Approval for Treating Patients with Drug-Refractory, Symptomatic Paroxysmal Atrial Fibrillation.January 8, 2025，Johnson & Johnson Announces Suspension of External Evaluation and Commercial Application of Varipulse in the United States(hereinafter referred to as the "Suspension Event"),And claimed that they are investigating.The cause of four stroke events reported in external assessments after patient treatment is still unclear, and it is unknown when product promotion will resume.This is not good news for Johnson & Johnson, whose product has only been on the market for two months.First, Johnson & Johnson is already behind Boston Scientific and Medtronic in the PFA race, with no advantage in time-to-market; second, although the product has not yet been launched in China, the suspension incident may more or less influence the regulatory approval decisions in other countries, casting a shadow over future market promotion.The Next Important Inflection PointPulsed Field Ablation (PFA) represents the cutting edge of the cardiac electrophysiology field, with top global electrophysiology players competing to enter the market.
*The principle of PFA is to create tiny pores in the target cardiac tissue through short pulses, thereby blocking the electrical signals that cause arrhythmia. Compared with traditional ablation techniques, this method is increasingly favored as it can reduce the risk of damage to surrounding tissues and shorten operation time.Currently,Boston Scientific, MedtronicLeading the Way:
- In December 2023, Medtronic's PulseSelect pulsed field ablation device received FDA approval, becoming the first pulsed field ablation technology to gain FDA approval.
- In January 2024, Boston Scientific's pulsed field ablation device FARAPULSE received FDA approval.
As of now, the U.S. FDA has approved a total of five PFA products for marketing: two from Boston Scientific (FARAPULSE and FARAWAVE NAV), two from Medtronic (Pulseselect and Sphere-9&Affera), and one from Johnson & Johnson (Varipulse）。As the "focus" of this incident,Johnson & Johnson's Self-Developed Pulsed Electric Field AblationVaripulseThe system has successfully launched in Japan, the EU, and the US in January, February, and November 2024, respectively; in China, the system has entered the "green channel" and is awaiting approval.Johnson & Johnson has considerable strength in the electrophysiology field. In 1997, it acquired Biosense for $400 million. Shortly after, in 1998, Johnson & Johnson merged Cordis Webster (Cordis' ablation business) with Biosense (mapping business), laying the foundation for what is now Biosense Webster (Electrophysiology).In 2015, Biosense Webster had already captured 40% of the global cardiac electrophysiology market. Entering 2023, Johnson & Johnson expanded its electrophysiology business into the heart failure sector by acquiring artificial heart manufacturer Abiomed. From the perspective of broad electrophysiology revenue data,Surged to the second position in the industry.
*** Cardiac rhythm products mainly include: Implantable Cardioverter Defibrillators (ICD), Automated External Defibrillators (AED), etc.;*** Heart failure products mainly include: pacemakers, artificial hearts, etc.;*** Cardiac electrophysiology products mainly include: mapping, ablation instruments, catheters, etc.;As PFA represents the next significant overt competition point in the electrophysiology industry, Johnson & Johnson naturally does not want to fall behind.VaripulseHighly anticipated. Although Johnson & Johnson does not have the first-mover advantage in terms of approval time compared to Boston Scientific and Medtronic, as a veteran player in the global electrophysiology field, Varipulse still has some unique features.For example3D Mapping Technology, which is a core competitive advantage of PFA products, helps reduce X-ray exposure time and is particularly favored by doctors.In contrast, the "first-generation" PFA products from Boston Scientific and Medtronic do not have 3D mapping capabilities. It is only with their second-generation products, FARAWAVE NAV (Boston Scientific) and Sphere-9 & Affera (Medtronic), that this feature is introduced. From this perspective, Johnson & Johnson's first-generation PFA product already includes 3D mapping technology, and its launch in the U.S. market was just one month apart from the second-generation products of Boston Scientific and Medtronic.But this suspension incident has undoubtedly created opportunities for competitors. Needham analyst Michael Matson pointed out,Even if sales resume later, Varipulse may suffer reputational damage as a result of this incident, and doctors will likely exercise more caution when using it.This means more market share and development space for Medtronic and Boston Scientific. Previously, in Johnson & Johnson's Admire pivotal study, three out of 277 patients experienced cerebrovascular events, a risk that has now been magnified, further weakening the competitiveness of Varipulse in the market.
Yesterday's closing saw Johnson & Johnson Medical's stock price fall by 2.71%, reaching its lowest point in nearly four years.Target share marked with a question markIn December 2024, a survey conducted by Citibank among 72 U.S. industry experts and doctors showed that, on average, these doctors expected that49%The use of PFA equipment will exceed 39% in 2024.In contrast, traditional ablation technologies are gradually "being overlooked," such as
- Radiofrequency ablation (accounting for 40%) will drop to 33% of all surgeries, which is currently the most commonly used technical approach;
- The share of the more "old-school" cryoablation will drop from 21% to 18%.
A new survey by Citi Research shows,Doctors predict that the market share of each company will change next year.Medtronic 56% (of which PulseSelect accounts for 11%, Affera accounts for 45%), Boston Scientific 33%, Johnson & Johnson 10%。In 2025, this should have been a critical moment for the global PFA market with fierce competition, but following this suspension incident,Johnson & JohnsonWill there be a temporary absence? All the above predictions must be questioned.But it is certain that, as a latecomer, Johnson & Johnson was originally in the role of a "market grabber." Therefore, to some extent, its products need to have either more stable safety or greater uniqueness.Johnson & Johnson stated that, as of January 3, 2025, Varipulse has treatedMore than 3,000 casesThe patient previously completed more than 130 external evaluation cases in the United States.Johnson & Johnson added that it hopes to convey more information about the latest findings in the coming days, and noted that the commercialization of Varipulse outside the United States remains unaffected because "the assessment outside the U.S. utilized a unique platform configuration."It is reported that there are many electrical parameters for forming a pulsed field, and the key to the success of PFA surgery lies in the selection of treatment parameters; otherwise, complications may occur due to improper operation.In the Chinese market,Currently, a total ofFive modelsPFA products are distributed among five companies: Apart from global leaders Boston Scientific and Medtronic, some Chinese manufacturers, although latecomers, are not lagging in pace, including Jinjiang Electronics, Dennon Electrophysiology, and HT Medical, all of which have products launched in the Chinese market. 2025 will beThe critical moment for these products to scale commercially.In 2025, the blockbuster battle in electrophysiology takes a dramatic turn!--Featured Recommendations--
