Boston Scientific Updates Instructions for Cryoablation Balloons After Reports Of Severe Injuries
Boston Scientific Updates Instructions for Cryoablation Balloons After Reports Of Severe Injuries
The updates emphasize the risk of atrio-esophageal fistula and practices that may minimize risk, based on the observation that location, frequency, and intensity of cryoablation applications may be contributing factors to this complication.On Wednesday, Boston Scientific Corporation (NYSE:BSX) revised the usage guidelines for its Polarx and Polarx FIT cryoablation balloon catheters following reports of serious injuries, including seven cases of esophageal damage and four deaths.
在週三，波士頓科學公司（NYSE:BSX）修訂了其Polarx和Polarx FIt冷凍消融氣囊導管的使用指南，因收到嚴重傷害的報告，包括七例食道損傷和四例死亡。
Boston Scientific is updating use instructions for POLARx Cryoablation Balloon Catheters due to a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation.
波士頓科學公司因在房顫導管消融程序後收到比預期更多的食道損傷報告，特別是心房食道瘻，正在更新POLARx冷凍消融氣囊導管的使用說明。
Also Read: Why Is Medical Device Giant Boston Scientific Stock Trading Higher On Monday?
另請閱讀：爲什麼醫療器械巨頭波士頓科學的股價在週一上漲？
The updates emphasize the risk of atrio-esophageal fistula and practices that may minimize risk, based on the observation that location, frequency, and intensity of cryoablation applications may be contributing factors to this complication.
更新強調了心房食道瘻的風險以及可能降低風險的實踐，基於觀察到的冷凍消融應用的位置、頻率和強度可能是這一併發症的影響因素。
The use of affected product may cause serious adverse health consequences, including atrio-esophageal fistula leading to air bubbles blocking blood vessels in the brain (cerebral air embolism), stomach and intestinal (gastrointestinal) bleeding, a system-wide infection (septic shock), and death.
使用受影響的產品可能導致嚴重的不良健康後果，包括心房食道瘻導致的空氣泡阻塞大腦血管（腦氣栓）、胃腸出血、全身感染（膿毒性感染）和死亡。
The devices, approved in the U.S. in August 2023, treat recurrent atrial fibrillation (an irregular heartbeat). Polarx has been in use in Europe since 2020.
這些設備於2023年8月在美國獲批，用於治療反覆發作的房顫（心律不齊）。Polarx自2020年以來在歐洲使用。
Updated instructions now emphasize:
更新的說明現在強調：
- Monitoring the catheter's position relative to the esophagus.
- Avoiding cryotherapy directly over the esophagus.
- Using established practices for balloon positioning, esophageal monitoring, and nerve safety.
- 監測導管相對於食道的位置。
- 避免對食管直接進行冷凍療法。
- 使用已建立的氣囊定位、食管監測和神經安全性實踐。
Earlier this week, Boston Scientific announced a recall for a subset of Accolade pacemaker devices with an increased risk of permanently entering Safety Mode. This mode has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart's rhythm and rate in some patients.
本週早些時候，波士頓科學宣佈召回一部分Accolade心臟起搏器設備，這些設備有較高風險會永久進入安全模式。該模式功能有限，並已與某些患者的起搏器無法正常調節心臟節律和速率有關。
A device that enters Safety Mode should be replaced. The increased risk of permanently entering Safety Mode in this subset of Accolade pacemaker devices is due to the battery underpowering the system because of a manufacturing issue.
進入安全模式的設備應當被更換。此部分Accolade心臟起搏器設備永久進入安全模式的風險增加是因爲製造問題導致電池供應不足。
Price Action: BSX stock is up 0.96% at $89.52 at last check Friday.
價格動態：截至上週五最後一次檢查，BSX股票上漲了0.96%，成交價爲89.52美元。
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譯文內容由第三人軟體翻譯。