- The primary safety endpoint of freedom from death, target lesion revascularization (TLR) or any amputation of the index limb to 30 days post-procedure, was met by 99.6 percent of the patients.
- The study also exceeded the primary efficacy endpoint with a statistically significant improvement over the objective performance goal established by the FDA and VIVA Physicians, Inc. for vessel patency at one year.
- Based on survival analysis, the SUPERA stent achieved freedom from loss of primary patency at one year of 86 percent.
- Freedom from TLR of 90 percent
- Zero reported stent fractures at one year.
IDEV's Pivotal SUPERB Trial Demonstrates SUPERA® Stent Significantly Exceeds VIVA Criteria For One-Year Patency In Femoropopliteal Artery Disease
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