Device Dossier

Sapphire NC 24 - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Sapphire NC 24 - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic,…

Intended purpose

Sapphire NC24 Coronary Dilatation Catheter is for balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. > Post stenting dilation to achieve stent optimization

Functional description

The Sapphire NC24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014-inch guidewire under fluoroscopy to proceed with accepted PTCA techniques to cross the lesions. Once Sapphire NC24 is into the lesion, the physician will use the radiopaque marker bands to position the usable (dilating) section of the balloon with the stenosis. The balloon is then inflated & deflated according.

TGA Public Summary