Boston Scientific (NYSE:BSX) said it finished enrolling 1,684 patients in a clinical trial of its next-generation Synergy drug-eluting stent, aiming to use the data to back regulatory nods in the U.S. and Canada.
The Evolve II trial will compare the Synergy stent with Natick, Mass.-based Boston Scientific’s Promus Element Plus stent. The Synergy device is coated with everolimus and uses a bioabsorbable polymer designed to elute the drug for 3 months, leaving a bare platinum-chromium stent behind. The Promus Element Plus leaves the polymer coating behind after the drug has been absorbed.
"The Synergy stent is the most flexible, conformable and deliverable drug eluting stent I have ever deployed," lead investigator Dr. Dean Kereiakes of the Christ Hospital Heart and Vascular Center in Cincinnati said in prepared remarks. "I am very pleased that the Evolve II trial enrolled so quickly and look forward to the study results for this innovative stent which was designed for optimal vessel healing."
"Completing enrollment of Evolve II in just nine months is just one example of how Boston Scientific and the physician community are advancing cardiology together," added interventional cardiology president Kevin Ballinger. "The Synergy product underscores our ongoing commitment to delivering meaningful innovation to the interventional cardiology community and reinforces our position as a global leader in medical devices."