Device Dossier

Ryurei - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for Ryurei - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic, Class…

Intended purpose

intended to be used for percutaneous transluminal coronary angioplasty (PTCA) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.

Functional description

This is a rapid exchange PTCA balloon dilatation catheter. The tip of the catheter is equipped with a balloon inflatable to a specific diameter and length at recommended pressures. The balloon has one or two radiopaque markers for confirmation of its position in the vessel under high resolution fluoroscopy. The inner lumens facilitates passage of a guide wire, and balloon inflation/deflation. The catheter is partially coated with hydrophilic polymer which generates lubricity when wet.

TGA Public Summary