Business Wire07.01.16
SRS Medical Systems Inc. has received CE mark approval for use of its Spanner Temporary Prostatic Stent across Europe. The Spanner is an alternative to both indwelling (Foley) and intermittent urinary catheters for male patients with bladder outlet obstruction (BOO).
“The Spanner is proven to have significant impact on medical outcomes, and often has a transformational impact on patient quality of life,” said Lee Brody, CEO of SRS Medical. “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 Spanner is a completely internal device that alleviates BOO while maintaining continence. It allows patients to naturally fill and empty their bladders, often without device awareness. The Spanner has many clinical applications for treating BOO, including:
In the United States, the Spanner is approved by the U.S. Food and Drug Administration (FDA) for a single 30-day period in a limited patient population. In January, SRS Medical received FDA investigational device exemption (IDE) approval for a confirmatory safety study to expand the labeling of the device.
The CE mark is a result of notified body transfer to Intertek Semko AB.
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 LUTS. 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 Spanner is placed blindly without anesthesia, in a procedure similar to the placement of a Foley catheter. The Spanner is reimbursed under CPT Code 53855, and is the only prostate stent on the U.S. market.
SRS Medical develops diagnostic tools and treatments for urologists and patients experiencing LUTS. The company is based in Billerica, Mass.
“The Spanner is proven to have significant impact on medical outcomes, and often has a transformational impact on patient quality of life,” said Lee Brody, CEO of SRS Medical. “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 Spanner is a completely internal device that alleviates BOO while maintaining continence. It allows patients to naturally fill and empty their bladders, often without device awareness. The Spanner has many clinical applications for treating BOO, including:
- Relieving lower urinary tract symptoms (LUTS) 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; and
- Predicting BPH procedure outcomes in high-risk surgical candidates.
In the United States, the Spanner is approved by the U.S. Food and Drug Administration (FDA) for a single 30-day period in a limited patient population. In January, SRS Medical received FDA investigational device exemption (IDE) approval for a confirmatory safety study to expand the labeling of the device.
The CE mark is a result of notified body transfer to Intertek Semko AB.
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 LUTS. 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 Spanner is placed blindly without anesthesia, in a procedure similar to the placement of a Foley catheter. The Spanner is reimbursed under CPT Code 53855, and is the only prostate stent on the U.S. market.
SRS Medical develops diagnostic tools and treatments for urologists and patients experiencing LUTS. The company is based in Billerica, Mass.
