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The **AGENT Drug-Coated Balloon (DCB)** is a monorail, semi-compliant percutaneous coronary intervention catheter developed as a drug-device combination. Its balloon surface is coated with **paclitaxel**, an antiproliferative chemotherapeutic agent, formulated in the proprietary **TransPax** coating, which includes the excipient acetyl tributyl citrate (ATBC)[1][3][5]. The device is used for **coronary angioplasty**, specifically to treat in-stent restenosis (ISR) in patients with coronary artery disease (CAD) whose coronary arteries have re-narrowed or become blocked following a previous stent insertion[1][6]. The balloon delivers a single, high-dose transfer of paclitaxel to the arterial wall, inhibiting neointimal proliferation and preventing further restenosis without leaving a permanent implant[1][4][5]. The AGENT DCB is the first and only coronary drug-coated balloon approved in the U.S. and provides an alternative to placing additional metal stents in previously stented coronary arteries[1][6].
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