Positive data from EVOLVE trial of Synergy Cardiac Stent system (Boston Scientific) - 16-May-2012

Data from the EVOLVE trial shows the Synergy everolimus-eluting Coronary Stent system, from Boston Scientific, demonstrated non-inferior results in treating de novo coronary artery lesions at one year compared to the Promus Element everolimus-eluting stent system. The trial reported one-year clinical and six-month intravascular ultrasound (IVUS) outcomes data, evaluating the safety and effectiveness of the Synergy stent. Data demonstrated that both versions of the Synergy Stent (loaded with both full- and half-dose everolimus) are clinically non-inferior to the Promus Element stent. There were no significant differences between groups for all IVUS parameters evaluated at 6 months, including neointimal area, stent or lumen area, net volume obstruction, incomplete stent apposition or minimum lumen diameter. The EVOLVE trial data are expected to support CE Mark approval, which is expected later this year.