Device Dossier

Ranger™ OVER-THE-WIRE Paclitaxel-Coated PTA Balloon Catheter - Peripheral angioplasty balloon catheter, drug-eluting

Device Dossier for Ranger™ OVER-THE-WIRE Paclitaxel-Coated PTA Balloon Catheter - Peripheral angioplasty balloon catheter, drug-eluting (Peripheral…

Intended purpose

Indicated for percutaneous transluminal angioplasty (PTA) in adults with de novo or restenotic lesions located in native superficial femoral and proximal popliteal arteries (SFA / PPA) and infrapopliteal arteries.

Functional description

The Ranger Paclitaxel-Coated PTA Balloon Catheter is an 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 Drug-Coated Balloon (DCB) is designed to inhibit restenosis by delivering drug to diseased arterial tissue.

TGA Public Summary