Johnson & Johnson Resumes Limited U.S. Sales of VARIPULSE™ PFA System Following Safety Review

Feb 18, 2025 20:22 CST Updated 20:22

Johnson & Johnson

Medical Device R&D and Manufacturer

Medtronic

Medical Device Manufacturer

According to ReutersNote: On February 14, Johnson & Johnson resumed limited sales of its products in the United States.Varipulse Cardiac Device。

Johnson & Johnson subsequently stated that the potential devices, surgeries, and patientsThe investigation into patient-related factors has concluded.The VARIPULSE™ device is operating as intended, with no performance differences among the globally available configurations of the VARIPULSE™ system.。

November 7, 2024Johnson & Johnson's Varipulse Pulsed Field Ablation System Receives FDA Approval for Treating Patients with Drug-Refractory, Symptomatic Paroxysmal Atrial FibrillationIs the third approved company in the U.S. market, following Medtronic and Boston Scientific.

January 8, 2025，Johnson & Johnson Announces Suspension of External Evaluation and Commercial Application of Varipulse in the United States，And claimed that the investigation is ongoing.Causes of Four Stroke Events Reported in External Evaluations Following Patient Treatment.Johnson & Johnson Has Lost Its First-Mover Advantage in the PFA Market, and the Suspension of Sales Has Cast a Shadow.

Johnson & Johnson is currently communicating with healthcare professionals using VARIPULSE™, advising them to review and adhere to the latest IFU, and to share the information with patients.

Corporate financial reports show that Johnson & Johnson's cardiovascular revenue in 2024$7.707 billion, year-on-yearIncrease by 21.4%. In the strong sector of electrophysiology, the revenue for 2024$5.267 billion, year-on-yearGrowth of 12.3%。

Johnson & Johnson disclosed that competition from PFA in the U.S. market and volume-based procurement in the Chinese market have had a certain impact on this part of the business.

Notably, the current global PFA leader isMedtronic, Boston Scientific, Johnson & Johnson。

Boston ScientificTheFARAPULSE SystemAs the world's first commercialized PFA product, it received EU CE certification in January 2021, followed by FDA approval in the United States in January 2024, NMPA approval in China in July, and PDMA approval in Japan in September.

With the continuous growth of the FARAPULSE system in global core markets, the company's electrophysiology business revenue has achieved rapid growth. At the same time, the company keeps iterating its products, featuring three-dimensional mapping functionality.New Generation Catheter FARAWAVE NAVObtained FDA registration certification in the United States in October 2024.

MedtronicThePulseSelect SystemIt has received marketing approval from the EU CE in November 2023, the U.S. FDA in December 2023, Japan's PDMA in May 2024, and China's NMPA in September 2024.

Among them, the product took the lead over FARAPULSE to become the first PFA product launched in the U.S. market, marking a significant event in its commercialization process. Meanwhile, another PFA product from Medtronic...Sphere-9The Affera mapping and ablation system, which is used in conjunction with it, received EU CE approval in March 2023 and U.S. FDA approval in October 2024, making the company the first in the industry to offer patients two clinical pathways for PFA technology.

Johnson & JohnsonTheVARIPULSE SystemApproved by Japan's PDMA in January 2024, the EU's CE in February 2024, and the US FDA in November 2024.

At the same time, the company is also actively promoting itsThermoCool SmartTouch SF CatheterAndOmnypulse CatheterThe development progress, where the ThermoCool SmartTouch SF catheter is a "PFA + radiofrequency" dual-energy catheter, and the Omnypulse catheter adopts an expandable basket design, integrating pressure monitoring and enhanced 3D mapping functions.

· END ·

--Featured Recommendations--