Boston Scientific Begins EVOLVE II Study of Bioabsorbable Synergy Drug-Eluting Stent

November 30, 2012— Boston Scientific Corporation (Natick, MA) announced that the first patient has been enrolled in the EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the company’s Synergy stent system and to support regulatory approvals in the United States and Japan for the treatment of atherosclerotic coronary lesions. The Synergy stent elutes the drug everolimus and features an ultrathin bioabsorbable polymer coating. The absorption of the polymer is completed shortly after drug elution ends at 3 months, stated the company.

According to Boston Scientific’s announcement, the EVOLVE II clinical program is anticipated to enroll approximately 2,000 patients at up to 160 sites worldwide, in countries including the United States, Canada, Europe, Australia, New Zealand, Japan, India, Brazil, and Singapore. Patients enrolled in the EVOLVE II trial will be followed for 5 years. The first patient was enrolled at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio. Dean Kereiakes, MD, of Christ Hospital is the principal investigator of the study.

“Synergy is the most flexible, conformable, and deliverable drug-eluting stent platform that I have ever deployed,” commented Dr. Kereiakes in the company’s press release. “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 company noted that the EVOLVE II clinical trial builds upon the EVOLVE study, which was a prospective, randomized, single-blind, first-human-use study. EVOLVE compared the Synergy stent to Boston Scientific’s Promus Element stent, which is coated with a durable polymer. In EVOLVE, outcomes with the Synergy stent were comparable to outcomes with the Promus Element stent at 6 months and 1 year.

Boston Scientific announced that it received CE Mark approval for the Synergy stent system in October 2012. 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, advised the company.