Device Dossier
ASAHI SION PTCA Guide Wire - Catheter guide wire
Device Dossier for ASAHI SION PTCA Guide Wire - Catheter guide wire (Cardiac/peripheral vascular guidewire, single-use, Class III, sponsor Bio-Excel).…
- GMDN category: Cardiac/peripheral vascular guidewire, single-use
Intended purpose
The ASAHI SION guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
Functional description
The proximal 2 to 3cm of the Asahi Sion PTCA guide wire is shaped to point in a certain direction (making it steerable) and the guide wire is steered through a guiding catheter into the coronary artery and across a lesion (narrowing or occlusion) within the coronary artery under x-ray fluoroscopy. The wire is then used as a railroad for advancement of a balloon and / or a stent to the site of the lesion.