Manufacturer > BD > Devices > Lutonix™ 035 Drug Coated Balloon PTA Catheter
Lutonix™ 035 Drug Coated Balloon PTA Catheter
Device-Type
Drug-Coated Balloons (SFA/Popliteal Indication)
Targated Speciality
Vascular
Manufacturer
BD
The LUTONIX® 035 Drug Coated Balloon PTA Catheter (LUTONIX® Catheter) consists of an over the wire catheter with a drug coated balloon fixed at the distal tip (Figure 1). The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The LUTONIX® Catheter is 0.035” guidewire compatible, with a low profile, semi-compliant balloon formed to a low profile tapered tip to facilitate advancement of the catheter to and through the stenotic region of the vessel. Two radiopaque marker bands delineate the working length of the balloon and are located under the proximal and distal ends of the balloon to facilitate fluoroscopic visualization of the balloon during delivery and placement. Non-radiopaque GEOALIGN® Marker Bands are designated on the catheter shaft by 1cm increment bands. Each 10cm increment is labeled with the distance from the distal balloon tip. Thicker bands denote the midway point (5cm) between the labeled distances. GEOALIGN® Marker Bands are designed to be used as a location reference tool. The proximal portion of the catheter includes an inflation female luer lock hub and a guidewire female luer lock hub. Each product is packaged with a balloon protector that has been positioned over the balloon and a disposable wire lumen stylet, both of which are to be removed prior to use.