Device Dossier

Ranger SL Paclitaxel-Coated PTA Balloon Catheters - Peripheral angioplasty balloon catheter, drug-eluting

Device Dossier for Ranger SL Paclitaxel-Coated PTA Balloon Catheters - Peripheral angioplasty balloon catheter, drug-eluting (Peripheral angioplasty…

Intended purpose

The Ranger SL balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac and infrainguinal arteries

Functional description

Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) balloon catheter with a semicompliant balloon coated with a formulation of paclitaxel (drug) and an excipient. The Ranger SL balloon catheters are designed to inhibit restenosis by delivering drug to diseased arterial tissue.

TGA Public Summary