Device Dossier

Agent Monorail Paclitaxel-Coated PTCA Balloon Catheter - Coronary angioplasty balloon catheter, drug-eluting

Device Dossier for Agent Monorail Paclitaxel-Coated PTCA Balloon Catheter - Coronary angioplasty balloon catheter, drug-eluting (Coronary angioplasty…

Intended purpose

The Agent DCB is indicated for Percutaneous Transluminal Coronary Angioplasty (PTCA) in the coronary arteries to treat in-stent restenosis (ISR) and de novo lesions including small vessel disease.

Functional description

The Agent Paclitaxel-Coated PTCA Balloon Catheter is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient. The balloon is inflated to expand the luminal diameter of a diseased vessel and deliver the drug coating to diseased arterial tissue to inhibit restenosis.

TGA Public Summary