预装血管支架系统(商品名:Express SD™)
产品名称:预装血管支架系统(商品名:Express SD™)
生产厂家:Boston Scientific
产品描述:


产品性能与组成

该产品由支架和输送系统组成,支架预装在内含半顺应性球囊的Monorail推送系统上。支架由316L不锈钢制成;输送系统上嵌有二处不透X线的标记, 可与规格为.014in.(0.36mm)或.018in.(0.46mm)的导丝配套使用,球囊的材料为Pebax7233。环氧乙烷灭菌,一次性使 用。

适用范围

该产品用于治疗外周血管病变。

注册号:SFDA(I) 20123460118

Product Details

Best-in-Class Compression Resistance

Minimal Foreshortening

Very Low Recoil


Express SD features a patented Tandem Architecture™ Stent Design

  • Macro™ Elements and additional proximal connectors engineered to provide strength, especially in ostial lesions
  • Micro™ Elements designed to provide flexibility during stent placement

Clinical Information

RENAISSANCE Clinical Trial


Overview The RENAISSANCE Trial was a prospective, multi-center, single arm study designed to evaluate the Express SD Renal Premounted Stent System in the treatment of atherosclerotic lesions in the aortorenal ostium.

The primary objective was to demonstrate superiority of the duplex triggered, angiographically-confirmed binary restenosis rate at 9-months over the 40% pre-specified Objective Performance Criterion (OPC) representative of PTRA. 

Trial Design The RENAISSANCE Trial enrolled 100 patients (117 lesions) with de novo or restenotic ostial atherosclerotic lesions ≤15mm long in vessels between 4.0 and 7.0mm diameter with diameter stenosis ≥70%. 

Outcomes Primary Endpoint: 21.3% binary in-stent restenosis rate at 9-months, defined as the proportion of target lesions with ≥50% diameter stenosis based on angiographic core lab assessment.


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