The ThermoCool SmartTouch dual-energy ablation catheter could offer a treatment option for AFib. [Image courtesy of Biosense Webster]

ThermoCool SmartTouch双能量消融导管可以为AFib提供治疗选择。[图片由Biosense Webster提供]

Johnson & Johnson MedTech

强生医疗技术公司

(NYSE: JNJ)

（纽约证券交易所：JNJ）

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announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter.

今天宣布，其双能ThermoCool SmartTouch SF导管获得CE标志批准。

The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping system.

。两者都与Carto 3电解剖绘图系统完全集成。

Johnson & Johnson MedTech expects to have TruPulse generator hardware compatibility available in the first half of 2025. When fully approved, it expects the system to provide the ability to switch between RF and PF energy. The catheter remains investigational in the U.S.

强生医疗技术公司预计在2025年上半年将提供TruPulse发生器硬件兼容性。当完全批准后，它希望该系统能够在RF和PF能量之间切换。该导管在美国仍处于研究阶段。

Results from its SmartfIRE clinical trial presented in April

4月发布的SmartfIRE临床试验结果

demonstrated 100% acute procedural success during standard electrophysiology mapping and ablation procedures. That study looked at drug-refractory symptomatic paroxysmal AFib patients. Additionally, investigators said 96.8% of patients showed no acute reconnections in the veins.

在标准电生理标测和消融程序中显示100%的急性手术成功。该研究着眼于药物难治性症状性阵发性AFib患者。此外，研究人员说，96.8%的患者静脉没有急性重新连接。

J&J MedTech has additional studies underway to bring the catheter to other geographies, including the U.S. News of this clearance comes days after

强生医疗技术公司（J＆J MedTech）正在进行进一步的研究，以将导管带到其他地区，包括几天后的美国消息

the company paused all U.S. cases using its Varipulse PFA system in the U.S.

该公司使用其在美国的Varipulse PFA系统暂停了所有美国案件。

“Based on our collaboration with electrophysiologists around the world, we know that each AFib procedure is different; having both RF and PF energy through one device will allow physicians to personalize each procedure based on patient anatomy and clinical need and offer a point-by-point workflow that many of our customers prefer,” said .

“基于我们与世界各地电生理学家的合作，我们知道每个AFib手术都是不同的；通过一个设备同时使用RF和PF能量将使医生能够根据患者的解剖结构和临床需求对每个手术进行个性化，并提供许多客户喜欢的逐点工作流程，”他说。

Jasmina Brooks

贾斯米娜·布鲁克斯

, president, Electrophysiology, Johnson & Johnson MedTech. “The dual-energy ThermoCool SmartTouch SF catheter offers the benefit of both energy modes in one familiar device. We are pleased to bring forward this innovation to enable electrophysiologists to deliver safe and effective procedures for patients in .

，强生医疗科技公司电生理学总裁。“双能ThermoCool SmartTouch SF导管在一个熟悉的设备中提供了两种能量模式的优点。我们很高兴提出这项创新，使电生理学家能够为患者提供安全有效的手术。

Europe

欧洲

impacted by AFib.”

受到亚投行的影响。”