SRS Medical Systems said yesterday it won CE Mark approval in the European Union for its Spanner temporary prostatic stent designed to be used as both an indwelling Foley catheter and an intermittent urinary catheter in male patients.
The Spanner device consists of a pair of anchors and a silicone tube and is designed to reduce resistance in the bladder neck and prostatic urethra without stenting the external sphincter, SRS said. It’s blind, anesthesia-free implantation procedure is similar to that for a Foley catheter, according to the company.
“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,” said in a press release.
In March, SRS Medical said it won approval from South Korea’s Korea Food and Drug Administration for the Spanner.
Earlier this year in January, SRS said it won the FDA’s approval for a clinical trial of its Spanner prostate stent for an expanded indication, a temporary implant designed to replace indwelling and intermittent urinary catheters.