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Express™ LD Iliac and Biliary Premounted Stent System ... | 合法醫療器材資訊網

Express™ LD Iliac and Biliary Premounted Stent System ...

ExpressLDIliacandBiliaryStentwasengineeredtoprovidetheperfectbalance...BenchtestingperformedbyBostonScientificCorporation....additionaldataonthesafetyandefficacyoftheExpress™VascularLDstent...MagneticResonanceImaging

 Express™ LD Iliac and Biliary Premounted Stent System ...

MELODIE Trial Summary

MELODIE is a prospective, multi-center, single arm study to obtain additional data on the safety and efficacy of the Express™ Vascular LD stent implantation in the treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic) in iliac arteries (common or external).

MELODIE Trial Objective

The objective was to demonstrate non-inferiority of the Express™ LD Stent for the treatment of atherosclerotic iliac artery lesions as compared to an objective performance criterion* (OPC), with a primary endpoint of mean percent luminal diameter loss at 6 months.

*Note: the OPC=15%, δ=5%.

Primary Endpoint

Definition

Angiographic mean percent loss of luminal diameter at 6 months post-procedure, defined as [POST MLD1 - FUP MLD2 / POST MLD] x 100 

1Post MLD = Post-pr...

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1. Express® LD Iliac Premounted Stent System | 合法醫療器材資訊網
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Express™ LD Iliac and Biliary Premounted Stent System ... | 合法醫療器材資訊網
Express LD Iliac and Biliary Stent was engineered to provide the perfect balance ... Bench testing performed by Boston Scientific Corporation. ... additional data on the safety and efficacy of the Express™ Vascular LD stent ... Magnetic Resonance Imaging Read More
Express® LD Iliac | 合法醫療器材資訊網
The Express LD Iliac Premounted Stent System consists of: 316L surgical grade ... with a gradient echo pulse sequence and a 3 Tesla MRI system. The artefact ... Read More
MRI Compatibility for PI Products | 合法醫療器材資訊網
Magnetic Resonance Imaging (MRI) Safety for ... Express® SD Renal and Biliary Premounted Stent Systems . ... Express® LD Iliac Premounted Stent System … Read More
Express™ LD | 合法醫療器材資訊網
Your doctor wants you to have a stent placed in your iliac artery. This is to help ... The safety and effectiveness of the Express LD Premounted Stent System was. Read More
Express® LD Iliac and Biliary Premounted Stent System ... | 合法醫療器材資訊網
The safety and effectiveness of his device for use in the vascular system have not been ... The Express LD Biliary Stent may cause image artifacts with MRI scans due to ... Express is an unregistered or registered trademark of Boston Scientific ... Read More
Express™ SD Renal and Biliary Premounted Stent System ... | 合法醫療器材資訊網
Express SD has the ideal balance of strength and precision for acute success, every ... The Express SD Stent couples excellent compression resistance with lower ... Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral ... Read More
Express® LD—The Stent of Choice. | 合法醫療器材資訊網
EXPRESS® LD ILIAC PREMOUNTED STENT SYSTEM. Prior to use ... stent should also be an Express LD Iliac Stent, or a stent of similar material composition, for component compatibility. ... MRI scans due to distortion of the magnetic field. Read More
Express™ LD Biliary | 合法醫療器材資訊網
Do not expose the Premounted Stent System to organic solvents (i.e. alcohol). • The safety and effectiveness of this device for use in the vascular system have not ... Read More
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