The Spanner Temporary Prostatic Stent - P060010/S013
This is a brief overview of information related to FDA’s approval to market this product.
Product Name: The Spanner Temporary Prostatic Stent
PMA Applicant: SRS Medical Systems, Inc.
Address: 76 Treble Cove Road Building 3,
North Billerica, MA 01862
Approval Date: October 7, 2022
Approval Letter: Approval letter
What is it?
The Spanner Temporary Prostatic Stent is a sterile, single-use silicone tube (stent), used to allow men who depend on a catheter to control their urination. The Spanner stent is placed in the part of the urethra surrounded by the prostate (prostatic urethra) for up to 30 days and then can be replaced.
The Spanner was originally approved for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination for men following minimally invasive surgery for an enlarged prostate, called benign prostatic hyperplasia or BPH, after initial post-treatment catheterization. This approval expands the indications for use to include patients who are not candidates for medicines or surgery to treat an enlarged prostate.
How does it work?
The Spanner Temporary Prostatic Stent is placed in a man’s urethra. It keeps the prostate from blocking or pressing on the urethra, which is the tube extending from the bladder to the tip of the penis.
A doctor uses an insertion tool to place the Spanner. The stent has a small, inflated balloon at one end that stays inside the bladder. This balloon keeps the Spanner tube in place. A string at the end of the Spanner is used to drain the balloon when it is time to remove the tube. A soft tab connected to the string helps keep the Spanner from moving into the bladder.
The Spanner is available in several lengths and tip designs. A sizing tool called the Surveyor helps determine which size of Spanner is necessary by measuring the distance from the top (proximal side) of the bladder neck to the bottom (distal side) of the bladder’s external sphincter muscle.
The Spanner allows urine to flow from the bladder through the part of the urethra that is being blocked or narrowed by an enlarged prostate gland. It holds the urethra open even though the prostate is pressing on it.
When is it used?
The bladder pushes urine out of the body through the urethra. Men cannot easily urinate if their prostate gland, which surrounds the urethra, enlarges and blocks the flow of urine. The Spanner Temporary Prostatic Stent allows some men with an enlarged prostate to urinate more effectively by temporarily keeping the urethra open.
The Spanner is intended to be used temporarily (up to 30 days) to maintain urine flow and allow voluntary urination for men who depend on a catheter and who are not candidates for medicines or surgery to address their enlarged prostate.
What will it accomplish?
In a prospective, multicenter, single-arm, open-label U.S. clinical study of the Spanner Temporary Prostatic Stent with 107 participants, 79 of the 107 (73.83%) men were able to achieve adequate bladder drainage over 90 days.
When should it not be used?
The Spanner Temporary Prostatic Stent should not be used if the patient has:
- An active urinary tract infection.
- A history of certain urologic conditions or surgery that could affect how the Spanner works.
- A prostate length that isn’t compatible with the length of the Spanner.
Additional information (including warnings, precautions, and adverse events)
- Summary of Safety and Effectiveness Data (SSED)
- Patient labeling
- Physician labeling
- PMA database entry