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 BPH Catheter System
PMA Applicant: Urotronic, Inc.
Address: 2495 Xenium Lane, Minneapolis, MN 55441
Approval Date: June 30, 2023
Approval Letter: Approval Order

What is it?

The Optilume BPH Catheter System includes two catheters: the Optilume BPH Prostatic Pre-dilation Catheter and Optilume BPH Prostatic Dilation drug coated balloon (DCB) Catheter, which is coated with the drug paclitaxel. The system is used to treat an enlarged prostate, also known as benign prostatic hyperplasia (BPH), when the prostate has grown large enough to prevent the flow of urine through the tube that allows urine to pass out of the body (urethra).

How does it work?

The Optilume BPH Catheter System enlarges, or dilates, the space between the prostate’s two lobes to increase urine flow through the urethra. The Pre-Dilation Catheter separates the prostate’s lobes. The DCB Catheter increases the dilation and separation while also transferring a drug (paclitaxel) to both the urethra where it crosses the prostate and to the prostate lobes to reduce prostate regrowth after the procedure.

When is it used?

The Optilume BPH Catheter System is used to treat obstructive urinary symptoms associated with BPH in men who are age 50 and older.

What will it accomplish?

A clinical study of 148 people showed that people who received the  Optilume BPH Catheter System (100) had improved International Prostate Symptom Scores (IPSS) and increased peak urinary flow rates for at least 12 months post-procedure.

When should it not be used?

The Optilume BPH Catheter System should not be used in people who have:

• Known hypersensitivity to paclitaxel or related compounds
• Active urinary tract infection
• Penile prosthesis
•  Artificial urinary sphincter

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• Post-Approval Report Schedule and Study Progress
• PMA Database Entry