SRS Medical Systems has enrolled first patients in a US Food and Drug Administration (FDA) investigational device exemption (IDE) study to extend the indications for Spanner Temporary Prostatic Stent.
Spanner temporary prostatic stent is an FDA-approved Class III medical device developed to maintain urine flow and allow for voluntary urination in certain male patients experiencing lower urinary tract symptoms (LUTS).
The device features two anchors and a silicone tube, which reduces resistance in the bladder neck and prostatic urethra without stenting the external sphincter.
Spanner stent has been designed as an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients.
The device, which is currently approved by the FDA for a single 30-day period in a limited patient population, can eliminate bladder outlet obstruction while maintaining continence in men with symptoms of urinary retention.
It enables patients to naturally fill and empty their bladders, helping in reducing the risk of urinary tract infection.
The expanded indication from the new study is anticipated to allow for long-term use of Spanner in all patients who are not candidates for traditional prostate treatments.
Outside of the US, the device serves as a tool to confirm bladder contractility and minimize medical complications in patients awaiting procedures for benign prostatic hyperplasia (BPH).
SRS Medical CEO Lee Brody said: “The Spanner often has a transformational effect on the health and well-being of our patients.
“We are excited for our study subjects to experience the wide variety of benefits of eliminating their chronic urinary catheters, and we look forward to working with FDA to offer the Spanner as a long-term solution to US male patients next year.”
Image: The Spanner temporary prostatic stent. Photo: courtesy of Business Wire.