Johnson & Johnson Enters PFA Market with FDA-Approved VARIPULSE System, Intensifying Competition with Boston Scientific and Medtronic

PFA (Pulsed Field Ablation) is a technology that utilizes high-intensity pulsed electric fields to create irreversible electroporation in biological tissues within an extremely short time frame (milliseconds, microseconds, nanoseconds). It is currently mainly applicable in the ablation treatment of atrial fibrillation.

Compared with the previously widely used radiofrequency and cryoablation technologies, PFA is highly anticipated due to its advantages such as short ablation time, effective treatment, and minimal side effects. It has even been dubbed the "leading cardiac ablation technology of the next decade."

The approval of Johnson & Johnson's PFA product marks the entry of this rapidly growing market into an era of "three-power competition."

Johnson & Johnson's VARIPULSE mainly consists of two parts: the VARIPULSE ablation catheter and the TRUPULSE generator.

TRUPULSE is the foundation of Johnson & Johnson's PFA ablation technology and has previously provided pulse energy for Johnson & Johnson's Varipulse pulsed ablation catheter and dual-energy ablation catheter Thermocool Smarttouch SF.

The VARIPULSE ablation catheter builds on the technology of Johnson & Johnson's LASSO mapping catheter. The VARIPULSE ablation catheter features 10 electrodes on its circular tip, which can be adjusted in size from 25mm to 35mm and allows for bidirectional curvature adjustment. However, the degree of curvature adjustment differs on each side, with one side adjustable up to 180 degrees and the other only up to 90 degrees. This design aims to make it suitable for use in all four pulmonary veins, including the right inferior pulmonary vein.

At the same time, this product is equipped with an 1800V bipolar configuration applied between two electrodes separated by one electrode, as well as between every two adjacent electrodes. Each PFA application also includes a microsecond-long biphasic pulse sequence among all three bipolar configurations, with an application duration of approximately 250 milliseconds.

It is worth mentioning that Johnson & Johnson's PFA product has two main advantages, the greatest of which is its perfect compatibility with Carto 3. It has been hailed as "the world's most powerful and advanced three-dimensional mapping system."

In May this year, Johnson & Johnson launched the new generation CARTO 3 V8, aiming to improve the efficiency, reproducibility, and accuracy of atrial fibrillation and other arrhythmia-related diseases. Specifically, CARTO 3 is an advanced three-dimensional mapping system that utilizes the principle of magnetic and electrical dual positioning for imaging. The magnetic field positioning, based on GPS technology, can locate the catheter position, while the electric field mainly serves to display the catheter.

Since its debut in 2009, CARTO 3 has become an indispensable technology for electrophysiology ablation. With the growing popularity of PFA, reliance on three-dimensional mapping technology will also increase. CARTO 3 is currently the most clinically trusted three-dimensional mapping technology. With the support of CARTO 3, Johnson & Johnson's PFA product may gain popularity among clinicians. Additionally, Johnson & Johnson’s robust ICE capabilities will also provide significant added value to this product.

However, in the fields where Johnson & Johnson takes pride, other companies have also started to catch up vigorously.

As mentioned earlier, in addition to Johnson & Johnson receiving FDA approval, two other major companies, Medtronic and Boston Scientific, also received FDA approval for their PFA products. Moreover, these two companies are the only ones to have simultaneously received approval from the NMPA, FDA, and Japanese regulatory authorities for the treatment of atrial fibrillation using PFA.

Among them, the Boston Scientific Farapulse system, the pioneer of PFA, is a device used to treat drug-refractory, recurrent, and symptomatic paroxysmal atrial fibrillation. The system mainly consists of a disposable cardiac pulsed field ablation catheter, a cardiac pulsed field ablation system, and a disposable steerable sheath, offering two main advantages.

In terms of energy transmission, the system is equipped with a multi-level pulsed electric field ablation energy source, offering three voltage parameter options. It can rapidly deliver energy while minimizing collateral tissue damage and provide continuous transmural ablation for persistent lesion treatment.

In terms of catheter design, the distal end of its ablation catheter adopts a "petal-shaped" design, with each of the five "petals" equipped with four electrodes, which can be controlled to open or close via a slider button. This design aims to adapt to different pulmonary vein morphologies while ensuring maximum contact between the electrodes on the catheter and the atrial myocardial tissue, facilitating rapid energy delivery, enhancing operational flexibility, and improving surgical efficiency.

As for Medtronic, its biggest highlight in the PFA field is not only its ability to treat paroxysmal atrial fibrillation but also to perform ablation on persistent atrial fibrillation. Its PulseSelect pulsed field ablation system enables rapid and effective pulmonary vein isolation through consistent and predictable energy delivery and catheter manipulation. This design aims to allow clinicians to seamlessly transition to PFA within their preferred workflow.

In addition, the Medtronic PulseSelect generator is equipped with an automatic overcurrent detection function, which can automatically detect and prevent excessive current transmission, enhancing safety during the treatment process. The PulseSelect PFA catheter also features 9 built-in electrodes for sensing, ablation, and pacing.

Not only that, but its fixed electrode spacing ensures not only the stability of the electric field but also enables predictable and consistent continuous energy delivery; the 20-degree forward tilt design increases the contact area between the electrode and tissue, ensuring uniform energy distribution.

In a nutshell, these two giants have profound technical accumulation in the PFA field, especially in terms of electric field parameters and stability. As for the previously relatively weak aspects, such as 3D mapping, both companies have started to "strengthen" them.

For example, recently, Medtronic announced that its Affara Mapping and Ablation System received FDA approval, which includes the Affera™ Prism-1 Mapping Software, addressing the previous gap in 3D mapping capabilities.

Boston Scientific is not to be outdone, recently announcing the acquisition of Cortex. This is an integrated platform developed for treating atrial fibrillation through comprehensive mapping and ablation. Its OptiMap™ system utilizes a basket catheter and proprietary algorithms to identify potential active atrial fibrillation triggers, empowering doctors to efficiently create personalized ablation strategies. The acquisition is expected to be completed in the first quarter of 2025.

As this market welcomes "new friends," the "old friends" are also continuously strengthening. It remains to be seen which of these three giants will ultimately stand out in the future.

The global PFA market is bustling, and Chinese companies certainly won't miss this popular track.

According to incomplete statistics from VCBeat, more than 10 companies currently have PFA product pipelines and have made considerable progress in expanding indications and achieving technical breakthroughs.

For example, in the aspect of indication expansion, Jinjiang Electronics successfully launched a clinical study on pulsed field ablation for the treatment of persistent atrial fibrillation in March this year. Meanwhile, the three-dimensional PFA product portfolio from Xinhanglu Medicine is expected to become the world’s only PFA product portfolio capable of mapping persistent atrial fibrillation and achieving personalized ablation.

In terms of technological breakthroughs, taking three-dimensional mapping as an example, the three-dimensional dielectric mapping technology developed by Jianhu Medical does not adopt the mainstream magnetic-electric dual positioning/magnetic-electric fusion technology. Instead, it achieves real-time three-dimensional high-precision positioning and imaging of human tissue structures by measuring and tracking the changes in the dielectric constants of different types of tissue cells in the human body under the influence of an electric field.

Xinhanglu Medicine's "Four-Dimensional Cardiac Mapping System" has, for the first time, seamlessly integrated magnetic and electrical contact mapping technology with magnetic and electrical non-contact mapping technology at both the technical development and clinical application levels, forming a unified mapping architecture.

All these achievements are the hard-earned results of Chinese companies. However, the road ahead remains far from smooth. Currently, the R&D situation in the PFA market is still primarily focused on clinical trials and the approval stage. The challenges involved in progressing from prototype development to clinical application are self-evident, compounded by the substantial investment and high risks associated with the clinical stage. These are all pressures that companies must bear and challenges they need to face.

"As a result, an industry insider once told VCBeat: 'Two years ago, there were more than 40 companies in the market involved in PFA, but now, the number of companies that can successfully advance to the clinical stage or complete clinical trials is less than a hundred.'"