BILLERICA, Mass--(BUSINESS WIRE)--SRS Medical, Inc., announced today the publication of additional clinical efficacy data on the use of its Spanner® Temporary Prostate Stent. The Canadian Journal of Urology published the clinical results of 214 stent placements in male patients with symptoms of benign prostatic hyperplasia (BPH). The findings affirm that the fully-internal device effectively restores natural urination with a low infection rate and high patient quality of life.
Data showed that The Spanner allowed patients to maintain natural urination, reducing the measure of urine remaining in the bladder after void by 81%. Each device was implanted for 30 days, with six of 214 placements resulting in a symptomatic urinary tract infection (0.93 infections per 1,000 stent days). In comparison to published data on chronically catheterized male patients, Spanner patients demonstrated a greater than 75% reduction in symptomatic infection rate as compared to indwelling catheter patients.
“Our patients are having remarkable clinical success with The Spanner,” said Richard Roach, MD, author of the study and partner at Advanced Urology Institute of Oxford, FL. “Men who transition to the stent are often able to break the cycle of urinary tract infections caused by catheter use. In addition, eliminating the catheter has a profound impact on the patient’s medical condition and overall health.”
Unlike urinary catheters, The Spanner does not require external components to enable bladder drainage. Instead, a completely internal design permits The Spanner to stent the prostate while maintaining urinary continence. The device preserves natural voiding habits, often with no device awareness, and reduces exposure to potentially harmful bacteria in the surrounding environment.
“The Spanner Stent is a significantly better clinical solution than a urinary catheter for most male retention patients,” said Lee Brody, CEO of SRS Medical. “The stent offers a higher quality of life, with lower complication rates, including the elimination of most urinary tract infections caused by catheter use. The high efficacy reported in the recent peer-reviewed literature is consistent with the clinical successes that our urologist clients and their patients are experiencing around the world.”
About The Spanner Stent
The Spanner Temporary Prostatic Stent is CE marked and an FDA-approved Class III medical device intended to maintain urine flow and allow for voluntary urination in certain male patients experiencing lower urinary tract symptoms (LUTS). The device consists of two anchors and a silicone tube that reduces resistance in the bladder neck and prostatic urethra without stenting the external sphincter. The Spanner is placed blindly without anesthesia, in a procedure similar to the placement of a Foley catheter. The Spanner is reimbursed under CPT Code 53855.
About SRS Medical
SRS Medical is dedicated to improving the health and well-being of men experiencing LUTS. The company, based in Billerica, Mass., does this by delivering innovative, cost-effective tools to urologists, enabling them to better diagnose and treat these patients. For more information about SRS Medical: www.srsmedical.com.