EVOLVE II trial proceeds for Synergy cardiac stent system
Boston Scientific Corporation has completed enrolment in the EVOLVE II randomized, controlled clinical trial. The EVOLVE II trial is designed to further assess the safety and effectiveness of the Synergy Stent System and support FDA and Japanese regulatory approvals for the treatment of Atherosclerotic Coronary Lesions.
The Synergy stent uses the market-leading everolimus drug and features an ultra-thin directional polymer coating that is absorbed by the body shortly after drug elution ends at three months.Boston Scientific received CE Mark approval for the Stnergy Stent System in October 2012.
The EVOLVE II clinical trial builds upon the EVOLVE study, which was a prospective, randomized, single-blind, first-in-human use study comparing the Synergy Stent System to the Promus Element Stent System, which uses a durable polymer coating. Two-year outcomes with the Synergy stent in EVOLVE were presented earlier this year at the EuroPCR Scientific Program in Paris and showed low rates of target lesion revascularization (1.1 per-cent) and no stent thrombosis with the Synergy stent throughout two years.
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