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Stryker Neurovascular | 合法醫療器材資訊網

Stryker Neurovascular

MRISafety(NeurovascularUse).Non-clinicaltesting...MRISafety(PeripheralUse)...Neuroform®MicrodeliveryStentSystem,NeuroformEZ®StentSystem ...

 Stryker Neurovascular

Non-clinical testing and analysis have demonstrated that Neuroform Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neurovascular coil mass. A patient with Neuroform Stent can be safely scanned immediately after placement of this implant, under the following conditions:

Static magnetic field of 1.5 and 3.0 Tesla Spatial gradient field up to 2500 Gauss/cm (25 Tesla/m) Normal operational mode for gradients and SAR (maximum whole body averaged specific absorption rate (SAR) of lower than 2.0 W/kg and maximum head SAR of lower than 3.2 W/kg) for a total active MR scan time (with RF exposure) of 15 minutes or less per scan sequence.

In an analysis based on the temperature rises in non-clinical testing of stents and the calculated SAR in the patient during an MR scan, Neuroform Stents were determined to product an in-vivo tempe...

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Understanding Your Cerebral Aneurysm | 合法醫療器材資訊網
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THE List | 合法醫療器材資訊網
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Summary of Safety and Probable Benefit | 合法醫療器材資訊網
2005年5月26日 — The CORDIS ENTERPRISE TM Vascular Reconstruction Device and Delivery System is ... self-expanding, neurovascular stent and delivery system. ... Conditional in MRI systems operating at field strengths of 3.0 T or less ... Read More
Summary of Safety and Probable Benefit | 合法醫療器材資訊網
2017年11月2日 — Shurtleff Enterprise Vascular Reconstruction Device and Delivery System ... Neuroform Atlas Stent should not migrate in this MRI environment. Read More
Stryker Neurovascular | 合法醫療器材資訊網
MRI Safety (Neurovascular Use). Non-clinical testing ... MRI Safety (Peripheral Use) ... Neuroform® Microdelivery Stent System, Neuroform EZ® Stent System ... Read More
CRH z) New Humanitarian Device Approval | 合法醫療器材資訊網
2007年5月8日 — CORDIS ENTERPRISE Tm Vascular Reconstruction Device and Delivery ... Regular imaging tests will show if the aneurysm begins to grow or ... The performance and safety of two or more overlapped stents has not been ... Read More
SSED | 合法醫療器材資訊網
2019年12月16日 — PMA P180027: FDA Summary of Safety and Effectiveness Data. Page 1 ... and Atlas Stent Systems (H020002) and the Codman & Shurtleff, Inc. Enterprise. Vascular ... approved neurovascular flow diverting stent in the US and was approved wit Read More
Comparison of Enterprise With Neuroform Stent | 合法醫療器材資訊網
由 Y Kadkhodayan 著作 · 2013 · 被引用 58 次 — The Enterprise stent is the first closed-cell stent designed to treat wide-necked intracranial aneurysms. ... Neuroradiology/Head and Neck Imaging. Original ... Delayed thrombosis or stenosis following Enterprise- Read More
Original Article The efficacy of Enterprise stent | 合法醫療器材資訊網
2018年4月30日 — necked aneurysms by magnetic resonance angiography ... embolization was superior than non-Enterprise stent-assisted coil embolization in treating intracranial wide necked ... the micro-catheter compatible with the spring. Read More
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