Device Dossier

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Catheter,…

Intended purpose

The balloon catheter expands the stenotic portion of a coronary artery or bypass graft stenosis during PTCA. Balloon catheter models that are 2.25 to 4.00 mm in diameter are also indicated for post-delivery expansion of balloon-expandable stents.

Functional description

The Sprinter Legend Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) rapid exchange system. The balloon can be inflated to a defined diameter at a specific pressure. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the the catheter. Radiopaque balloon markers enable accurate placement.

TGA Public Summary