The first patient has been enrolled in the EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the Synergy Stent System (Boston Scientific) and support US Food and Drug Administration (FDA) and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.
Boston Scientific received CE mark approval for the Synergy Stent System in October 2012. The EVOLVE II clinical programme is anticipated to enrol approximately two thousand patients at up to 160 sites worldwide including the United States, Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore. The first patient was enrolled at the Christ Hospital, Lindner Research Center, Cincinnati, USA.
The Synergy Stent uses an 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.
“Synergy is the most flexible, conformable and deliverable drug-eluting stent platform that I have ever deployed,” said Dean Kereiakes, Christ Hospital, and the principal investigator of the study. “I am enthusiastic about its potential impact on patient care since the Synergy System was designed to reduce the risk of late adverse events and the need for prolonged dual antiplatelet therapy, which is often associated with a higher risk of bleeding, as well as increased cost.”
The EVOLVE II clinical trial builds upon the EVOLVE study. EVOLVE was a prospective, randomised, single-blind, first-in-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 trial will 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 United States and Japan.