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

ExpressLDIliacandBiliaryStentwasengineeredtoprovidetheperfectbalanceof...Visi-Protested:8x37mm.Palmaz...MRICompatibilityforPIProducts.

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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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 of ... Visi-Pro tested: 8 x 37 mm. Palmaz ... MRI Compatibility for PI Products. Read More

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