Device Dossier

HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for HoperTM PTCA balloon dilatation catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon…

Intended purpose

• The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. • The balloon dilatation catheter is also indicated for post-delivery expansion of balloon expandable stents.

Functional description

Hoper PTCA Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) RX System. The proximal shaft is a polymer coated stainless steel tube. The semicompliant balloon material allows dilatation with precise control of balloon diameter and length. Two radiopaque platinum markerbands are located within the balloon segment. The product can be used to expand stenotic coronary vessel, and improve myocardial bleeding.

TGA Public Summary