Boston Scientific AGENT Drug Coated Balloon Coronary DCB for ISR

Boston Scientific AGENT™ Drug-Coated Balloon
The Boston Scientific AGENT™ Drug-Coated Balloon is a paclitaxel-coated coronary balloon catheter designed for percutaneous transluminal coronary angioplasty (PTCA) in patients with coronary in-stent restenosis (ISR). The device combines a semi-compliant monorail intracoronary balloon catheter with Boston Scientific’s TransPax™ drug coating, which includes paclitaxel 2.0 µg/mm² and acetyl tributyl citrate (ATBC) excipient to support rapid and efficient drug transfer to the vessel wall.

Boston Scientific describes the AGENT platform as purpose-built for deliverability, low tip profile, and reliable drug transfer in complex coronary anatomy.

Key Features
Product Type: Drug-coated coronary balloon catheter for treatment of coronary ISR
Drug: Paclitaxel with dose of 2.0 µg/mm² of balloon surface
Coating Technology: TransPax™ coating with paclitaxel + ATBC excipient for efficient drug delivery
Inflation Time: Recommended inflation time of at least 30 seconds per IFU
Profile: Ultra-low lesion entry profile (0.43 mm / 0.017 in)
Balloon Diameters: 2.00 mm, 2.25 mm, 2.50 mm, 2.75 mm, 3.00 mm, 3.50 mm, and 4.00 mm
Balloon Lengths: 12 mm, 15 mm, 20 mm, 30 mm, with 40 mm available in some markets
Pressure Specifications: Nominal pressure 6 atm; rated burst pressure 12–14 atm depending on size

Clinical Applications
The Boston Scientific AGENT Drug-Coated Balloon is used in coronary PCI as a treatment option for in-stent restenosis, providing vessel expansion and local delivery of paclitaxel without leaving an additional metal layer behind. Boston Scientific describes it as the first FDA-approved coronary drug-coated balloon in the United States, while FDA materials state it is used when a previously stented coronary artery has narrowed again because of coronary artery disease.

Some non-US materials also reference use in de novo lesions, including small vessel disease, so indication wording should be aligned to the intended market before publication.

Product Information
Product Name: Boston Scientific AGENT™ Drug-Coated Balloon
Brand: Boston Scientific
Product Type: Paclitaxel-coated coronary balloon catheter / drug-coated balloon (DCB)
Balloon Type: Semi-compliant intracoronary balloon catheter
Drug: Paclitaxel
Drug Dose: 2.0 µg/mm²
Excipient / Coating Technology: ATBC excipient with TransPax™ coating technology
Lesion Entry Profile: 0.43 mm / 0.017 in
Balloon Diameters: 2.00 mm to 4.00 mm
Balloon Lengths: 12 mm to 30 mm, with 40 mm listed in some markets
Clinical Use: Coronary ISR treatment in PCI; market-specific indication wording should be confirmed before listing