Device Dossier
Sapphire 3 - Angioplasty catheter, balloon dilatation, coronary, basic
Device Dossier for Sapphire 3 - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic,…
- GMDN category: Angioplasty catheter, balloon dilatation, coronary, basic
Intended purpose
For balloon dilatation of a stenotic portion of a coronary artery in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
Functional description
Sapphire 3 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 3 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 accordingly.