SRS Medical Systems, Inc. has received CE mark approval for use of its Spanner Temporary Prostatic Stent across the European Economic Area. It serves as an alternative to both indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction.
The Spanner is a completely internal device that alleviates bladder outlet obstruction while maintaining continence. It allows patients to naturally fill and empty their bladders, often without device awareness.
The Spanner has many clinical applications, including:
- Relieving lower urinary tract symptoms in patients in temporary urinary retention, including those recovering from surgical procedures
- Reducing infection risk and medical complication in patients awaiting procedures for benign prostatic hyperplasia (BPH)
- Offering long-term symptom relief for patients unfit for prostate procedures
- Predicting BPH procedure outcomes in high-risk surgical candidates
The Spanner Temporary Prostatic Stent is 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. 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 stent is placed blindly without anesthesia, in a procedure similar to the placement of a Foley catheter.
In the United States, the device is approved by the FDA for a single 30-day period in a limited patient population. In January 2016, SRS Medical received FDA investigational device exemption approval for a confirmatory safety study to expand the labeling of the Spanner.
The CE mark is a result of notified body transfer to Intertek Semko AB.