Device Dossier

Toray Inoue Balloon Kit - Catheter, valvuloplasty, balloon dilatation

Device Dossier for Toray Inoue Balloon Kit - Catheter, valvuloplasty, balloon dilatation (Catheter, valvuloplasty, balloon dilatation, Class III, sponsor…

Intended purpose

The Toray Inoue Balloon Kit is indicated for Percutaneous Transvenous Mitral Commissurotomy (PTMC) in patients with mirtal stenosis.

Functional description

the kit contains a Inoue baloon catheter for dilation of mitral valve, Balloon Stretching tube for elongation of the balloon, Dilator for the dilation of the insetion site, Guidewire for guiding of the cathter and dilator, Stylet for directing the balloon to the valve, Syringe for inflation of the balloon, and ruler for the maesurement of the balloon diameter.

TGA Public Summary