Intracoronary Drug Delivery Balloon Procedures
Percutaneous coronary intervention with a drug-coated balloon for coronary in-stent restenosis in adult individuals is considered investigational under this policy, which was added on 04/01/2026. The AGENT paclitaxel-coated balloon received FDA premarket approval in February 2024 for in-stent restenosis in coronary arteries 2.0 mm to 4.0 mm in diameter with lesions up to 26 mm in length, and no drug-coated balloons are FDA-approved for de novo coronary lesions or small coronary vessel disease. Investigative treatments are not considered medically necessary, and Federal Employee Program members may have FDA-approved devices assessed only on the basis of medical necessity.