Compression resistance and conformability are crucial stent attributes that help improve vessel patency within tortuous vasculature.
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.
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).
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%.
1Post MLD = Post-procedure minimum lumen diameter.
2FUP MLD = Follow-up minimum lumen diameter at 6 months.