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Boston Scientific enrolls patients for new stent trial

by Brendon Nafziger, DOTmed News Associate Editor | August 05, 2010
Boston Scientific began signing up patients for clinical trials of Synergy, its new bioabsorbable, drug-eluting stent.

"Current technology today typically employs a polymer and drug combination on the drug-eluting stent," a Boston spokesman told DOTmed News. "And while the drug gets absorbed typically by the vessel wall, polymer tends to remain on the stent."

But with Boston's new stent the drug-delivering polymer coating reabsorbs into the body after it's done releasing its anti-clotting drug, leaving behind a bare-metal stent, the company said.

By reducing the amount of polymer and drug the vessel wall is exposed to, it could reduce clotting and other known stent hazards, the company said.

"This type of treatment option could play an important role in helping reduce adverse events such as late stent thrombosis," principal investigator of the trial, Ian Meredith, a professor and director of MonashHeart in Melbourne, Australia, said in a statement.

The trial, given the moniker EVOLVE, will enroll 291 patients at up to 35 sites in Europe, Australia and New Zealand, Natick, Mass.-based Boston said. In the trial, Synergy will be compared against Promus Element, Boston's platinum-chromium stent, with European, but not U.S., approval.

Patient enrollment should wrap up by the middle of next year, Boston said, with results of the trial likely used in its application for CE mark approval for the stent.

The Synergy stent was previously known as the Evolution stent.