Express® SD Renal Monorail® Premounted Stent System

 

This product is also indicated for the palliation of malignant neoplasms in the biliary tree. Click here for more information on this and other Boston Scientific products that are approved for use in biliary procedures.

Built to Perform with Precision and Performance

Design

• Additional connections in the proximal end of the stent are designed to provide excellent support, especially in ostial lesions
• Tandem Architecture™ Stent Design combines Micro™ and Macro™ Elements developed to balance strength, lumen coverage and deliverability

1. Long Macro™ Elements designed to give Express SD Stent radiopacity.
2. Additional connections in the proximal end of the stent.
3. Short, narrow Micro™ Elements designed to give Express SD Stent flexibility during placement.

Precision

Customized balloon lengths for each stent size are designed to limit balloon overhang Engineered for minimal stent shortening and accurate placement

Deliverability

• Based on Maverick® Monorail® Balloon Catheter technology, the design features a Laser-bonded tip engineered for improved tracking
• 0.014/0.018" compatible system, specifically developed for excellent access and superb performance
• Low profile; 6F guide catheter-compatible up to 6.0mm

Clinically Proven In Renal Arteries

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.

• Primary Endpoint: 21.3% (21/108) 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.

Freedom from TLR through 3 Years by Kaplan-Meier Analysis

Freedom from Target Lesion Revascularization (TLR) by Kaplan-Meier Analysis

• 9 months* – 92%
• 1 year – 91%
• 2 years – 88%
• 3 years – 83%

* Measured at 300 days

Hypertension Control through 3 years

Systolic Blood Pressure Statistical improvement from baseline at 3 years (p=0.0003)
Matched data by time point N=50

• Baseline 156.15±18.21
• 3 years 140.61±22.30

Diastolic Blood Pressure No significant difference from baseline at 3 years (p=0.0510)
Matched data by time point N=50

• Baseline 75.41±11.71
• 3 years 71.27±9.20

Serum Creatinine
Matched data by time point N=47

• Baseline 1.28±0.40 per subject
• 9 months 1.34±0.60
• 2 years 1.36±0.51
• 3 years 1.38±0.56

Zero patients progressed to dialysis through 3 years.

Additional Trial Information

• Purpose: Evaluate the safety and efficacy of the Express® SD Stent in subjects with ARAS (atherosclerotic renal artery stenosis)
• 100 patients/117 renal arteries
• 14 sites in the U.S.
• Technical Success Rate: 99.1% [116/117], defined as less than 30% residual stenosis immediately after stent depolyment based on visual assesment, including post-dilatation
• Follow-up Rate at 9 months: 93% [92/99]
• Follow-up Rate at 2 years: 90% [85/95]
• Follow-up Rate at 3 years: 89% [82/92]

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