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EMBLEM MRI S | 合法醫療器材資訊網

EMBLEM MRI S

BasedonLATITUDEDateonFile,BostonScientific2017.**Forfullwarrantytermsand...3501,EMBLEMS-ICDElectrode.4711,EMBLEMS-ICDElectrode ...

 EMBLEM MRI S

The EMBLEM MRI S-ICD system provides effective defibrillation without transvenous leads, offering a less invasive solution for patients at risk of sudden cardiac arrest.

Preserves the vasculature Eliminates potential for vascular injury, transvenous lead insertion complications, lead-associated tricuspid regurgitation,  mechanically induced pro-arrhythmia, and transvenous lead failure and associated extraction risk Remains outside the sternum, never touching the heart

The 2017 Guidelines by the American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS) include recommended use of the S-ICD for ICD indicated patients with1:

  

High Infection Risk

~75% of ICD Indicated Patients with ≥1 Comorbidities Associated with Device Infection.2, 3, 4

References

1....

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Important Medical Device Advisory | 合法醫療器材資訊網
Summary. • Approximately 47,000 EMBLEM S-ICD1 Subcutaneous Electrodes (Model 3501) have been distributed worldwide since 2017 with an overall survival ... Read More
Product Advisories | 合法醫療器材資訊網
A Product Advisory is a voluntary letter issued to inform physicians of an anomalous device ... June 2021 EMBLEM Electrode 3501 Removal Physician Letter. Read More
Urgent Field Safety Notice | 合法醫療器材資訊網
2020年12月24日 — Subject: Important Medical Device Advisory - EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) with a potential for electrode body fracture ... Read More
AU | 合法醫療器材資訊網
2020年12月6日 — Subject: Important Medical Device Advisory – EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) with a potential for electrode body fracture ... Read More
EMBLEM MRI S | 合法醫療器材資訊網
Based on LATITUDE Date on File, Boston Scientific 2017. **For full warranty terms and ... 3501, EMBLEM S-ICD Electrode. 4711, EMBLEM S-ICD Electrode ... Read More
EMBLEMTM MRI S | 合法醫療器材資訊網
1. EMBLEM MRI S-ICD User's Manual 359480-001 EN US 2015-11. 2. MRI Technical Guide 359474-001 EN US 2015-11. Compatible Electrodes. 3400, 3401, 3501. Read More
Boston Scientific Recalls EMBLEM S | 合法醫療器材資訊網
2021年2月10日 — Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures ... The FDA has identified this as a Class I ... Read More
Boston Scientific EMBLEM S | 合法醫療器材資訊網
由 SC Remole 著作 · 2021 — On December 2, 2020, a medical advisory letter regarding EMBLEM S-ICD subcutaneous electrode model 3501 (Boston Scientific, Marlborough, ... Read More
Class 1 Device Recall EMBLEM | 合法醫療器材資訊網
2021年1月19日 — Product, EMBLEM S-ICD Subcutaneous Electrode Model 3501. ... Boston Scientific will post the product advisory letter on our website, ... Read More
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