instructions for use (IFU)

DEVICE DESCRIPTION

The Serranator® PTA Serration Balloon Catheter is an Over The-Wire (OTW) balloon dilatation catheter designed to perform Percutaneous Transluminal Angioplasty (PTA) for peripheral indications. The Serranator has a nylon semi-compliant balloon with embedded external metal strips or scoring elements. The unique scoring elements are serrated, designed to create linear, interrupted scoring along the endoluminal surface. This occurs during balloon inflation and is designed to aid arterial expansion.

INTENDED USE/INDICATIONS FOR USE

The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro- vasculature.