Optilume® Urethral Drug Coated Balloon – P210020
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Optilume® Urethral Drug Coated Balloon
PMA Applicant: Urotronic, Inc.
Address: 2495 Xenium Lane N, Minneapolis, MN 55441
Approval Date: December 3, 2021
Approval Letter: Approval Order
What is it?
The Optilume® Urethral Drug Coated Balloon (DCB) uses a drug-coated balloon attached to the end of a urethral catheter to expand the urethra, that may be abnormally narrowed (stricture). The balloon is coated on its outer surface with paclitaxel, a drug that may help preserve the expansion of the stricture and maintain improved urinary flow.
How does it work?
A physician inserts the balloon catheter into the portion of the urethra that has a stricture. The balloon is inflated to expand the urethra which will allow improved urine flow. During the balloon expansion, paclitaxel is transferred from the balloon to the urethra wall to prevent the stricture from reoccurring.
When is it used?
The Optilume® DCB is used to treat patients, primarily adult males, with urinary symptoms associated with urethral stricture.
What will it accomplish?
Use of the Optilume® DCB is intended to improve urinary flow rate through at least six months in patients with urethral stricture.
When should it not be used?
The Optilume® DCB should not be used in patients who have:
- A known hypersensitivity to the drug paclitaxel or structurally related compounds.
- Urologic implants such as penile implants or artificial urinary sphincters.