The new stent has been developed as an alternative to both indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction (BOO).
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 is a completely internal device, which relieves BOO while maintaining continence. It enables patients to naturally fill and empty their bladders, even though there is less knowledge on the device.
The device can be used in multiple clinical applications to treat BOO, including alleviating lower urinary tract symptoms (LUTS) in patients in temporary urinary retention.
It will also help in reducing infection risk and medical complication in patients awaiting procedures for benign prostatic hyperplasia (BPH).
The US Food and Drug Administration (FDA) has approved Spanner for a single 30-day period in a limited patient population.
In January this year, the firm obtained FDA investigational device exemption (IDE) approval for a confirmatory safety study to expand the labeling of prostatic stent.
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."
Image: SRS Medical’s Spanner temporary prostatic stent. Photo: courtesy of Business Wire.
