US-based medical device company SRS Medical Systems has secured the CE mark approval for its spanner temporary prostatic stent (STPS) in the European Economic Area (EEA).
The spanner acts as an alternative to indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction (BOO).
The internally placed device allows the patient to relieve their bladders without being conscious of the device presence.
SRS Medical CEO Lee Brody said: "The Spanner is proven to have significant impact on medical outcomes, and often has a transformational impact on patient quality of life.
"We are excited to receive this approval, and we look forward to working with our European partners to deliver The Spanner to the patients that will benefit from it the most."
The US Food and Drug Administration (FDA) approved STPS is a Class III medical device designed to maintain urine flow and enable voluntary urination in male patients with lower urinary tract symptoms (LUTS).
The device features two anchors and a silicone tube which minimises resistance in the bladder neck and prostatic urethra without stenting the external sphincter.
The application of the spanner does not require anesthesia.
The spanner, apart from treating BOO, also reduces infection risk and medical complication in patients who will be subjected to benign prostatic hyperplasia (BPH) treatment.
It has the ability to predict a potential BPH treatment outcome in the patients.
The spanner results long-term relief for patients who are unfit to undergo prostate procedures.
Image: SRS Medical’s Spanner Temporary Prostatic Stent. Photo: courtesy of Business Wire.