Device Dossier

Coronary angioplasty catheter RIVER CTO - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Coronary angioplasty catheter RIVER CTO - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

The application of the coronary angioplasty catheter is indicated for improving lumen diameter with coronary vessels including narrow and tortuous vessels in the following patients with symptomatic coronary vessels disease caused by de novo atheroscleroticchanges or restenosis in coronary arteries (length ≤ 40 mm)

Functional description

Coronary angioplasty catheter is a „Rapid Exchange” catheter with a high pressure semi-compliant balloon near the distal tip. The distal section of the catheter is dual lumen. The outer lumen is used for inflation of the balloon, and the inner lumen is used for guide wire (.014” / 0.36 mm). The proximal section of the catheter is a single-lumen. Catheter includes a radiopaque markers aids in the precision placement of the catheter’s balloon in a vessel.

TGA Public Summary