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Express™ SD

Renal and Biliary Premounted Stent System

The Express SD Stent couples excellent compression resistance with lower stent foreshortening and recoil. Only Express SD has the ideal balance of strength and precision for acute success.

Key Resources

Express SD Stent System Directions for Use Patient Guide - Understanding Renal Artery Disease Indications, Safety, and Warnings

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Product Details

Best-in-Class Compression Resistance

Express™ SD Renal and Biliary Premounted Stent System Compression Resistance bench test results Express™ SD Renal and Biliary Premounted Stent System Compression Resistance bench test results

Compression Resistance defined as the force required to compress the fully expanded stent. Compression Resistance measured using the hoop force tester in 37° C air. Bench testing performed by Boston Scientific Corporation. Data on file. N=3. Express SD, RX Herculink Plus, Herculink Elite, PALMAZ Blue and Racer stents tested: 6 x 18 mm. Formula 418 RX tested: 6 x 20mm. Bench test results may not necessarily be indicative of clinical performance.

 

Minimal Foreshortening

Express™ SD Renal and Biliary Premounted Stent System Foreshortening bench test results Express™ SD Renal and Biliary Premounted Stent System Foreshortening bench test results

Foreshortening defined as the change in stent length from crimped conditions to nominally expanded condition in 37° C water, as measured by a magnified vision system. Bench testing performed by Boston Scientific Corporation. Data on file. N=3. Express SD, RX Herculink Plus, Herculink Elite, PALMAZ Blue and Racer stents tested: 6 x 18 mm. Formula 418 RX tested: 6 x 20mm. Bench test results may not necessarily be indicative of clinical performance.

 

Very Low Recoil

Express™ SD Renal and Biliary Premounted Stent System shows Very Low Recoil in Bench Tests Express™ SD Renal and Biliary Premounted Stent System shows Very Low Recoil in Bench Tests

Stent Recoil defined as the change in stent diameter from nominally pressurized catheter to non-pressurized catheter condition in 37° C water, as measured by a magnified vision system. Bench testing performed by Boston Scientific Corporation. Data on file. N=3. Express SD, RX Herculink Plus, Herculink Elite, PALMAZ Blue and Racer stents tested: 6 x 18 mm. Formula 418 RX tested: 6 x 20mm. Bench test results may not necessarily be indicative of clinical performance.

 

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

Express SD features a patented Tandem Architecture™ Stent Design Express SD features a patented Tandem Architecture™ Stent Design

 

 

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.

 

5-Year Data

RENAISSANCE Clinical Trial 5-Year Data RENAISSANCE Clinical Trial 5-Year Data

 

Additional Results

RENAISSANCE Clinical Trial Results RENAISSANCE Clinical Trial Results

*Denominator consists of number of subjects who either died prior to late follow-up window and/or had follow-up to at least the early follow-up window.

**Denominator consists of number of subjects who either had CEC adjudicated device or procedure related death prior to late follow-up window and/or had follow-up to at least the early follow-up window.

†Matched data by time point.

For additional information, please see Rocha-Singh K, Jaff M, Kelley E.L. Renal Artery Stenting with Non-Invasive Duplex Ultrasound Follow-up: 3-Year Results from the RENAISSANCE Renal Stent Trial. Catheterization and Cardiovascular Interventions 2008; 72:853-862.

 

 

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