Lutonix Drug Coated Balloon PTA Catheter Model 9004 - Peripheral angioplasty balloon catheter, drug-eluting

Intended purpose

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.

Functional description

The Lutonix Catheter Model 9004 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 anti-proliferative drug paclitaxel. The catheter is .035” guidewire compatible with a low profile semi-compliant balloon & tapered tip to facilitate advancement. 2 radiopaque marker bands are located under the proximal & distal ends of the balloon to facilitate fluoroscopic visualization of the balloon.