FDA Approves Bioabsorbable Polymer Drug-Eluting Stent
The U.S. Food and Drug Administration approved on Oct. 5 Boston Scientific’s Synergy bioabsorbable polymer drug-eluting stent, the first device of its kind to receive approval. The stent limits long-term polymer exposure by absorbing the abluminal bioabsorbable drug after three months when the drug elution is complete.
The approval is based on the results of the EVOLVE II trial, which found the stent to be non-inferior to a durable-polymer drug-eluting stent.
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