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

Intended purpose

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

Functional description

The Agent Monorail PTCA balloon catheter has a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient that is designed to inhibit restenosis by delivering drug to diseased arterial tissue. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of guidewires to facilitate advancement of the catheter. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.