Device Dossier

iVascular Xperience Coronary semi-compliant balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for iVascular Xperience Coronary semi-compliant balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic…

Intended purpose

For percutaneous transluminal angioplasty of coronary arteries. The Xperience balloon catheter is suitable for balloon dilatation of the stenotic portion of a coronary artery or of stenosis of bypass grafts replacing coronary arteries, in order to improve myocardial perfusion.

Functional description

Rapid-exchange semi compliant balloon dilatation catheter for coronary artery dilatation. Proximal single lumen allows contrast to pass between proximal luer lock connector & balloon. The distal coaxial dual lumen is to: - carry contrast liquid to inflate the balloon - accommodates 0.014 guide wire to support the passage of the catheter. The catheter has 1 or 2 Radiopaque markers on the balloon for xray visualisation, is 142 cm long and is compatible with 5F Guide catheter.

TGA Public Summary