Device Dossier

Lutonix 014 Drug Coated Balloon PTA Catheter Model 9005 - Peripheral angioplasty balloon catheter, drug-eluting

Device Dossier for Lutonix 014 Drug Coated Balloon PTA Catheter Model 9005 - Peripheral angioplasty balloon catheter, drug-eluting (Peripheral…

Intended purpose

The Lutonix™ 014 Drug Coated Balloon Catheter is intended for use as a PTA catheter to dilate stenotic or obstructive vascular lesions in the popliteal and infra-popliteal arteries, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.

Functional description

Consists of an over-the-wire catheter with a drug coated balloon fixed at the distal tip of the catheter. The balloon is coated with a specialized formulation that includes the drug, paclitaxel. Compatible with a 0.014ʺ (0.36 mm) guidewire, with a low-profile, semi-compliant balloon formed to a low-profile tapered tip to facilitate advancement of the catheter. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement.

TGA Public Summary