Johnson & Johnson Pauses US Varipulse Procedures Amid Safety Review, Investigates Brain-Related Events
Johnson & Johnson Pauses US Varipulse Procedures Amid Safety Review, Investigates Brain-Related Events
On Wednesday, Johnson & Johnson (NYSE:JNJ) said it has temporarily paused all U.S. cases using its Varipulse pulsed field ablation (PFA) system.
周三，强生（纽交所：JNJ）表示已暂时暂停在美国使用其Varipulse脉冲场消融（PFA）系统的所有案例。
Pulsed-field ablation (PFA) is a non-thermal procedure that uses high-amplitude electrical pulses to treat cardiac arrhythmias (irregular heartbeat) and tumors.
脉冲场消融（PFA）是一种非热性程序，使用高幅度电脉冲治疗心脏心律失常（不规则心跳）和肿瘤。
In November, the FDA approved the Varipulse Platform for drug-refractory paroxysmal Atrial Fibrillation (AFib).
11月份，FDA批准了Varipulse平台用于药物耐受性阵发性房颤（AFib）。
Also Read: Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services
另请阅读：您的医疗费用正在飙升！美国在2023年的支出达到了5万亿，肥胖和糖尿病药物及医院服务显著增加。
The VARIPULSE Platform is designed to enable AFib treatment with a single device that combines PFA therapy and advanced mapping with the CARTO 3 System, a 3D electroanatomical cardiac mapping system.
VARIPULSE平台旨在通过一个设备结合PFA治疗和爱文思控股(CARTO 3系统)的先进映射，来实现对房颤的治疗，这是一个3D电解剖心脏映射系统。
"On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation," the company said.
公司表示：“1月5日出于谨慎考虑，强生医疗科技暂时暂停美国的外部评估和所有美国的Varipulse案例，同时我们调查在美国外部评估中报告的四起神经血管事件的根本原因。”
Neurovascular events are a range of conditions that affect the blood vessels and blood supply to the brain, spinal cord, and peripheral nerves.
神经血管事件是影响大脑、脊髓和外周神经的血管及血供的多种疾病。
Since the beginning of the external evaluation, the company has reported more than 130 cases of Varipulse in the U.S., spread across 14 sites and 40 operators. Globally, it has reported more than 3,000 commercial cases with Varipulse.
自外部评估开始以来，公司在美国报告了超过130例Varipulse案例，分布在14个地点和40个操作者中。在全球范围内，它报告了超过3000例Varipulse的商业案例。
"We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation," the company said in its statement. "We expect to have more information to communicate within the coming days."
“我们正在努力根据我们的医疗安全流程完成调查，并恢复美国外部评估，”公司在声明中表示。“我们预计在接下来的几天内会有更多信息可以沟通。”
Last month, the FDA issued a complete response letter (CRL) to Johnson & Johnson's Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration in patients with non-small cell lung cancer with epidermal growth factor receptor mutations.
上个月，FDA向强生的生物制品许可证申请发出了完整响应信（CRL），该申请是针对用于非小细胞肺癌患者皮下给药的阿美妥单抗和重组人透明质酸酶的固定组合。
The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility.
该CRL与制造设施标准预批准检查过程中观察到的事项相关。
Price Action: JNJ stock closed at $146.23 on Wednesday.
价格动态：周三强生股票收盘价为146.23美元。
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译文内容由第三方软件翻译。
