Boston Scientific (NYSE:BSX) said the 1st patient was enrolled in the Evolve II clinical trial of its Synergy drug-eluting stent, aiming to use the data to back applications for approval in the U.S. and Japan.
The Natick, Mass.-based medical device company’s everolimus-coated stent uses a bioabsorbable polymer designed to elute the drug for 3 months, leaving a bare platinum-chromium stent behind.
The 2,000-patient trial will follow its subjects for 5 years, according to a press release.
"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," interventional cardiology president Kevin Ballinger said in prepared remarks. "This underscores our commitment to the drug-eluting stent market and reinforces our position as a global market leader."
Last month Boston Scientific won CE Mark approval for the Synergy device in the European Union, saying it’s planning a commercial rollout early next year.