Boston Scientific Corp. (BSX) announced the first patient enrollment in the EVOLVE II trial, designed to further evaluate the safety and effectiveness of the SYNERGYStent System and support U.S. Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions. Boston Scientific received CE Mark approval for the SYNERGY Stent System last month.
The EVOLVE II program is expected to enroll nearly 2000 patients at up to 160 sites globally, including the U.S., Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore. The first patient was enrolled at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio. The SYNERGY Stent uses the everolimus drug and features an ultra-thin bioabsorbable polymer coating. The absorption of the polymer is completed shortly after drug elution ends at three months.
The EVOLVE II trial builds on the EVOLVE study, which was a prospective, randomized, single-blind, first human use study comparing the SYNERGY Stent to the PROMUS Element Stent, which uses a durable polymer coating. Outcomes with the SYNERGY Stent in EVOLVE were comparable to outcomes with the PROMUS Element Stent at six months and one year. Patients enrolled in the EVOLVE II study would be followed for five years. The SYNERGY Stent System is an investigational device in non-CE Mark countries and is not available for sale in the U.S. and Japan.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.