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