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…
- GMDN category: Coronary angioplasty balloon catheter, drug-eluting
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.