Recently, Johnson&Johnson MedTech announced its Dual Energy ThermoCool SmartTouch ™ The SF catheter has obtained European CE certification and is used to treat arrhythmias such as atrial fibrillation.

It is understood that this product is the second CE approved dual energy ablation catheter. The first one is Medtronic's Sphere-9 ablation catheter, which is a multifunctional, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter used to treat persistent atrial fibrillation and tricuspid valve isthmus dependent atrial flutter. It was approved by the FDA in October 2024.

The second dual energy ablation catheter
Dual Energy ThermoCool SmartTouch ™ The SF catheter is an ablation catheter with a porous head end saline infusion, which combines Thermocol smartpouch technology with SF catheter porous infusion technology. This product combines contact force sensing and advanced porous tip ablation technology, and adds stronger operability and torque to achieve excellent control.
It is understood that, Dual Energy ThermoCool SmartTouch ™ The core innovation of SF catheter lies in its dual energy therapy function. This catheter not only supports radiofrequency energy (RF), but also enables ablation therapy through pulsed field (PF) energy, greatly enhancing the flexibility and personalization of treatment. Unlike traditional radiofrequency catheters, this catheter can flexibly switch energy modes during treatment to meet the clinical needs and anatomical structures of different patients. Cooperate with TruPulse ™ Generator, Johnson&Johnson Medical Technology provides more customized treatment options for electrophysiology experts.

From the perspective of product structure, ThermoCool SmartTouch ™ The head of SF is evenly distributed in 56 saline infusion micropores at the tip of the ablation catheter, forming a layer of water film at the catheter tip to achieve uniform cooling. This reduces the temperature of the catheter tip during radiofrequency ablation, ensuring efficient transmission of radiofrequency energy and reducing the formation of scabs and small thrombi.

And, ThermoCool SmartTouch ™ Compared to ThermoCool SmartTouch, SF can achieve uniform cooling at half the flow rate, and compared to SMART-AF research, surgical time and fluoroscopy time distribution are reduced by 19% and 55%, respectively.

ThermoCool SmartTouch ™ In addition to the advantage of uniform cooling, SF also inherits ThermoCool smarttouch contact force sensing technology. This technology allows for active measurement of stable contact force and catheter tip direction; Capable of using precision springs to provide consistent motion in response to contact forces; Sending accurate position reference signals through position sensors and transmitter coils; Promote consistent lesion formation; Reduce ablation time; And improve the results through more stable catheter tissue contact force.

Currently, Johnson&Johnson Medical Technology is conducting more research to further evaluate Dual Energy ThermoCool SmartTouch ™ The application of SF catheter in other therapeutic fields. For example, the SmartPulse trial will be conducted in the United States, while the PulseSmart trial will be conducted in Australia and Canada to further explore the efficacy of the catheter in other regions.

PFA top three pattern suddenly unexpected
In recent years, the electrophysiological market has grown significantly, with the global market size expected to increase from $5.2 billion in 2023 to approximately $10.3 billion in 2032, reflecting a strong compound annual growth rate of 7.9%. In this rapidly growing field, pulsed electric field ablation (PFA) is undoubtedly a rising star, attracting major giants to compete and seize the market.

In November 2024, Johnson&Johnson's first PFA product, the Varipulse pulsed field ablation system, was approved by the US Food and Drug Administration (FDA) for the treatment of drug-resistant paroxysmal atrial fibrillation. After obtaining approval, Johnson&Johnson became the third company in the United States to have PFA technology for treating AFib, joining the ranks of Medtronic and Boston Scientific, and the PFA market's top three competition officially opened.
But after the beginning of 2025, on January 8th, according to the latest news from Reuters, Johnson&Johnson Medical Technology announced that due to reporting four neurovascular events during an external evaluation period, it will temporarily suspend the use of its newly launched Varipulse pulse field ablation system in the United States for cautious consideration and begin investigating the root causes of these neurovascular events.

Johnson&Johnson responded that the decision to suspend the use of the Varipulse system was based on a thorough investigation of four reported neurovascular events in external evaluations. Although the specific causes of these events have not yet been identified, Johnson&Johnson believes it is necessary to take cautious measures to ensure the safety of patients. A spokesperson for Johnson&Johnson pointed out that the Varipulse system used in external evaluation studies in the United States "utilizes a unique platform configuration" and therefore will not have an impact on commercial activities and cases receiving treatment outside the United States.

However, in any case, the sudden incident of the Varipulse pulsed field ablation system has left Johnson&Johnson one step behind in the PFA top three competition, and perhaps this event will also lay a "hidden thunder" for the commercial promotion of the product in the future.

Conclusion
In addition to the international market, the PFA market in China is also a battleground for major giants. Currently, five PFA products have been approved in the Chinese market. At the same time, domestic medical device companies are also thriving. Currently, Jinjiang Electronics, Deno Electrophysiology, Huitai Medical and other companies have products listed in China.

Source: https://news.yaozh.com/archive/44821.html