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.
在周三，波士顿科学公司（NYSE:BSX）修订了其Polarx和Polarx FIt冷冻消融气囊导管的使用指南，因收到严重伤害的报告，包括七例食道损伤和四例死亡。
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.
波士顿科学公司因在房颤导管消融程序后收到比预期更多的食道损伤报告，特别是心房食道瘘，正在更新POLARx冷冻消融气囊导管的使用说明。
Also Read: Why Is Medical Device Giant Boston Scientific Stock Trading Higher On Monday?
另请阅读：为什么医疗器械巨头波士顿科学的股价在周一上涨？
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.
更新强调了心房食道瘘的风险以及可能降低风险的实践，基于观察到的冷冻消融应用的位置、频率和强度可能是这一并发症的影响因素。
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.
使用受影响的产品可能导致严重的不良健康后果，包括心房食道瘘导致的空气泡阻塞大脑血管（脑气栓）、胃肠出血、全身感染（脓毒性感染）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.
这些设备于2023年8月在美国获批，用于治疗反复发作的房颤（心律不齐）。Polarx自2020年以来在欧洲使用。
Updated instructions now emphasize:
更新的说明现在强调：
- 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.
- 监测导管相对于食道的位置。
- 避免对食管直接进行冷冻疗法。
- 使用已建立的气囊定位、食管监测和神经安全性实践。
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.
本周早些时候，波士顿科学宣布召回一部分Accolade心脏起搏器设备，这些设备有较高风险会永久进入安全模式。该模式功能有限，并已与某些患者的起搏器无法正常调节心脏节律和速率有关。
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.
进入安全模式的设备应当被更换。此部分Accolade心脏起搏器设备永久进入安全模式的风险增加是因为制造问题导致电池供应不足。
Price Action: BSX stock is up 0.96% at $89.52 at last check Friday.
价格动态：截至上周五最后一次检查，BSX股票上涨了0.96%，成交价为89.52美元。
- Why Is Penny Stock Foresight Autonomous Stock Gaining Today?
- 为什么今天便士股Foresight Autonomous的股票在上涨？
Photo via Shutterstock.
图片来自shutterstock。