Express™ LD

Iliac and Biliary Premounted Stent System

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

Only Express LD Iliac and Biliary Stent was engineered to provide the perfect balance of compression resistance and conformability—without trade-off.

Key Resources

Indications, Safety, and Warnings

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Product Details

Compression resistance and conformability are crucial stent attributes that help improve vessel patency within tortuous vasculature.
compression resistance comparison chart
Compression Resistance measured as the force required to compress the fully expanded stent. Compression Resistance measured using a hoop force tester in 37° air. Conformability measured by torque required to achieve a constant curvature target as measured by angular deflection. Bench testing performed by Boston Scientific Corporation. Data on file. N = 3. Express LD tested: 8 x 37 mm. Visi-Pro tested: 8 x 37 mm. Palmaz Genesis tested: 8 x 39 mm. Omnilink Elite tested: 8 x 39 mm. Valeo tested: 8 x 36 mm. Assurant tested: 8 x 40 mm. Bench test results may not necessarily be indicative of clinical performance.

 

 

Express LD Stent System features a patented Tandem Architecture™ Stent Design

stent conformability

Micro™ Elements engineered to provide:

  • Flexibility during placement
  • Conformability upon deployment
  • Maximum apposition
stent compression resistance

Macro™ Elements engineered for:

  • Balanced compression resistance
  • Strength—even in arterial bifurcations
Express LD Iliac and Biliary Stent's Macro and Micro Elements

 

 

Clinical Information

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-procedure minimum lumen diameter.
2FUP MLD = Follow-up minimum lumen diameter at 6 months.

MELODIE Trial Primary Endpoint and Success

Outcome

  • Mean percent luminal diameter loss at 6 months = 16.2% ± 18.4%
  • Upper Confidence Int = 19.6%
  • Clinical follow-up rate at 6 months = 92.6% (138/150)
  • This rate was non-inferior to the Objective Performance Criterion = δof 20%

24-Month Results

  • The Express LD Stent = 8.9%, 10.2% TLR at 1 and 2 years and no device/procedure-related death
  • Sustained Stent Target Lesion Patency measured by CTA with 97.2% at 1 year and 94.1% at 2 years

 

 

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