FDA Update — Oct 12, 2026
FDA Update — Oct 12, 2026
• SELUTION SLR™️: First U.S.-approved sirolimus drug-eluting balloon for coronary ISR.
• FDA approval: Sep 18, 2026.
• Indication: vessels 2.25–4.50 mm, lesions ≤26 mm, after appropriate vessel preparation.
• Key advantage: ISR treatment without adding another permanent stent layer.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250041&utm_source=chatgpt.com
