Device Dossier
Advance 35LP Low Profile PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation
Device Dossier for Advance 35LP Low Profile PTA Balloon Dilatation Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon…
- GMDN category: Catheter, angioplasty, balloon dilatation
Intended purpose
Intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Functional description
Balloon lumen and inflation device are prepared with standard contrast-saline mixture. All air is purged from syringe & tubing. Inflation device is attached to the balloon lumen. Catheter lumen is flushed with heparinized saline solution. The balloon catheter is advanced over a .035in wire guide under fluoroscopy to the lesion site and is placed across the lesion using distal and proximal radiopaque balloon markers. Balloon is inflated to appropriate pressure and then deflated and withdrawn.