Boston Scientific has enrolled the first patient in a clinical trial to assess the safety and effectiveness of its coronary stent system, designed to treat atherosclerotic coronary lesions.
The CE-marked Synergy Everolimus-Eluting platinum chromium coronary stent system features a combination of everolimus drug and bioabsorbable PLGA polymer, whose absorption will be completed after drug elution ends at three months.
The clinical trial, named EVOLVE II, enrolled the first patient at the Christ Hospital, Lindner Research Center in Cincinnati, Ohio, US.
The multicentre trial is built upon the prospective, randomised, single-blind EVOLVE study, which compared the Synergy stent's outcomes with the Promus Element stent at six months and one year.
Christ Hospital spokesperson and study principal investigator Dr Dean Kereiakes said; "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 trial will enroll approximately 2,000 patients from 160 sites, who will be followed for five years, according to the company.
Boston Scientific interventional cardiology president Kevin Ballinger said; "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."
The company said the trial data will be used to support US Food and Drug Administration and Japanese regulatory approvals.
Image: Boston Scientific's corporate headquarters in Natick, Massachusetts, US. Photo: Courtesy of Boston Scientific.