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Regulatoryapprovedsirolimus drug-coated balloonPositive
AI Analysis
Summary
Cordis received FDA approval for a sirolimus drug-eluting balloon to treat coronary in-stent restenosis, marking the first and only device of its kind. The approval was granted with breakthrough device designation.
Outcome Details
FDA approval as first and only sirolimus drug-eluting balloon for coronary in-stent restenosis; designated as breakthrough device
Importance:8/10
Sentiment:
0.90
FDA approvalbreakthrough devicedrug-coated balloonsirolimuscoronary in-stent restenosisfirst-to-market
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Published by FierceBiotech on September 22, 2026 8:19 AM