Lutonix 018 Drug Coated Balloon PTA Catheter Model 9014 - Peripheral angioplasty balloon catheter, drug-eluting

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Disponible desde:

Bard Australia Pty Ltd

clase:

Class III

Fabricado por:

Lutonix Inc 1625 West 3rd Street, Tempe, Arizona, 85281 United States Of America

Área terapéutica:

62551 - Peripheral angioplasty balloon catheter, drug-eluting

indicaciones terapéuticas:

Lutonix 018 DCB consists of an over the wire catheter with a drug coated balloon fixed at the distal tip. The balloon is coated with a specialized formulation that includes the drug paclitaxel. The catheter is 0.018" guidewire compatible with a low profile semi-compliant balloon & low profile tapered tip to facilitate advancement. 2 radiopaque marker bands are positioned on the distal portion & 1 positioned on the proximal portion of the balloon to differentiate between the distal & proximal end The Lutonix? Catheter is intended for use as a PTA catheter to dilate stenotic or obstructive vascular lesions in the femoropopliteal arteries, and in native or synthetic arteriovenous fistulae, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.

Estado de Autorización:

A

Fecha de autorización:

2021-05-06