The first patient has been enrolled in Boston Scientific’s EVOLVE II clinical trial, 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.
Boston Scientific received CE Mark approval for the SYNERGY Stent System in October 2012. The EVOLVE II clinical program is anticipated to enroll approximately 2,000 patients at up to 160 sites worldwide including the U.S., Canada, Europe, Australia, New Zealand, Japan, India, Brazil and Singapore, and the first patient was enrolled at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio.
The SYNERGY Stent uses the market-leading 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, M.D., F.A.C.C., 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, 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.
"We continue to strengthen our drug-eluting stent portfolio with innovations like the SYNERGY System in an effort to increase the advanced treatment options available to physicians and patients," said Kevin Ballinger, president of interventional cardiology at Boston Scientific.
"This underscores our commitment to the drug-eluting stent market and reinforces our position as a global market leader."
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 U.S. and Japan.