Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit
Primary DI
00859937006209
Brand
Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit
Company
Urotronic, Inc.
Model
1235
Catalog number
OPTBDL7010B
Device description
Optilume Urethral Drug Coated Balloon Catheter kit (1235-TAB) consists of one Optilume Urethral Drug Coated Balloon catheter, one Optilume Basic Urological Dilation catheter and an Atrion Medical Inflation device. The Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use. The Optilume® Basic catheter is the same catheter as the Optilume® Urethral DCB without the drug coating. The Atrion Medical QL® Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that controls the plunger, a manometer to measure pressure and a connecting tube.
A sterile, flexible tube intended to be inserted into the urethra to open or increase the diameter of a constricted or irregular urethral passage; it includes a drug (e.g., chemotherapy drug) intended to be eluted in situ. The device is typically designed with an inflatable dilation balloon. This is a single-use device.