Device Dossier

NeuroSpeed PTA Balloon Catheter - Catheter, angioplasty, balloon dilatation

Device Dossier for NeuroSpeed PTA Balloon Catheter - Catheter, angioplasty, balloon dilatation (Catheter, angioplasty, balloon dilatation, Class III,…

Intended purpose

The NeuroSpeed® PTA Balloon Catheter is indicated for dilation of a stenosis in the cerebral arteries in order to improve perfusion. The NeuroSpeed® PTA Balloon Catheter is indicated for introduction of the self-expanding Credo® Stent.

Functional description

The single-use NeuroSpeed® PTA Balloon Catheter is an over-the-wire coaxial catheter with a balloon near the distal tip for percutaneous transluminal angioplasty (PTA). The balloon lumen and the guide wire lumen are coaxially designed. The NeuroSpeed has radiopaque markers to facilitate positioning under fluoroscopy. One radiopaque marker indicates the catheter tip, two additional radiopaque markers indicate the nominal length of the balloon.

TGA Public Summary