Device Dossier

Sapphire ULTRA Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Sapphire ULTRA Coronary Dilatation Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

For Balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia.

Functional description

The balloon material is made of semi-compliant material and has a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube and a inner tube with a balloon laser welded to both tubes at the distal tip.

TGA Public Summary