Evolve II: 2-year data for Boston Scientific’s Synergy stent
Boston Scientific‘s (NYSE:BSX) Synergy stent showed non-inferiority to its Promus Element Plus device after 12 months, according to data from the Evolve II trial presented yesterday at the annual conference of the American College of Cardiology.
The Synergy stent’s bioresorbable polymer coating is designed to dissolve completely after delivering its payload of the anti-restenosis drug everolimus, leaving behind a bare-metal stent. Synergy elutes the drug for about 3 months and the polymer coating is absorbed shortly thereafter.
At the 12-month mark of Evolve II, Synergy was non-inferior to the Promus Element Plus for target lesion failure, showing a TLF rate of 6.7% compared with 7.5% in the intent-to-treat population. There were no significant differences in death (1.1% for Synergy vs. 1.1% for PE+); myocardial infarction (5.4% Synergy vs. 5.0% PE+); TLR (2.6% vs. 1.7%); or stent thrombosis (0.4% vs. 0.6%).
“Evolve II demonstrated comparable safety and efficacy of Synergy to the PE+ stent. Longer-term follow up will provide insight into whether polymer type (bioresorbable vs. permanent) impacts late outcomes following stent deployment. Evolve II 2-year results will be presented for the 1st time at ACC 2016,” according to an abstract of the presentation.
The FDA approved the Synergy device in October 2015. Read more
The post Boston Scientific’s Synergy stent at 2 years | ACC 2016 roundup appeared first on MassDevice.
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