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.
週三，強生（紐交所：JNJ）表示已暫時暫停在美國使用其Varipulse脈衝場消融（PFA）系統的所有案例。
Pulsed-field ablation (PFA) is a non-thermal procedure that uses high-amplitude electrical pulses to treat cardiac arrhythmias (irregular heartbeat) and tumors.
脈衝場消融（PFA）是一種非熱性程序，使用高幅度電脈衝治療心臟心律失常（不規則心跳）和腫瘤。
In November, the FDA approved the Varipulse Platform for drug-refractory paroxysmal Atrial Fibrillation (AFib).
11月份，FDA批准了Varipulse平台用於藥物耐受性陣發性房顫（AFib）。
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另請閱讀：您的醫療費用正在飆升！美國在2023年的支出達到了5萬億，肥胖和糖尿病藥物及醫院服務顯著增加。
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平台旨在通過一個設備結合PFA治療和愛文思控股(CARTO 3系統)的先進映射，來實現對房顫的治療，這是一個3D電解剖心臟映射系統。
"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日出於謹慎考慮，強生醫療科技暫時暫停美國的外部評估和所有美國的Varipulse案例，同時我們調查在美國外部評估中報告的四起神經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.
神經血管事件是影響大腦、脊髓和外周神經的血管及血供的多種疾病。
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.
自外部評估開始以來，公司在美國報告了超過130例Varipulse案例，分佈在14個地點和40個操作者中。在全球範圍內，它報告了超過3000例Varipulse的商業案例。
"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."
「我們正在努力根據我們的醫療安全流程完成調查，並恢復美國外部評估，」公司在聲明中表示。「我們預計在接下來的幾天內會有更多信息可以溝通。」
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.
上個月，FDA向強生的生物製品許可證申請發出了完整響應信（CRL），該申請是針對用於非小細胞肺癌患者皮下給藥的阿美妥單抗和重組人透明質酸酶的固定組合。
The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility.
該CRL與製造設施標準預批准檢查過程中觀察到的事項相關。
Price Action: JNJ stock closed at $146.23 on Wednesday.
價格動態：週三強生股票收盤價爲146.23美元。
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譯文內容由第三人軟體翻譯。
