BILLERICA, Mass.--(BUSINESS WIRE)--SRS Medical Systems, Inc., today announced that it has received approval from the Korea Food and Drug Administration (KFDA) for broad use of its Spanner® Temporary Prostatic Stent in South Korea. The Spanner is an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients in urinary retention.
“The medical community has long recognized that urinary catheters cause significant medical complications, including urinary tract infections, and diminish patient quality of life,” said Lee Brody, CEO of SRS Medical. “The Spanner presents a rare opportunity to help providers improve outcomes, reduce cost and enhance the overall patient experience. Gaining authorization for use in South Korea is a significant step forward in our ongoing efforts to make The Spanner a worldwide standard of care for male patients in urinary retention.”
The Spanner is a completely internal device that eliminates bladder outlet obstruction while maintaining continence, allowing patients to naturally fill and empty their bladders, often without device awareness. It can be used in a variety of ways in lieu of a urinary catheter, such as:
- 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 addition to South Korea, The Spanner was also recently approved for use in Saudi Arabia by the Saudi Food and Drug Authority (SFDA). While global expansion for use of The Spanner continues, SRS Medical received U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval in January 2016 for a confirmatory safety study to expand the indications for use of The Spanner, the only prostate stent on the U.S. market. The device currently has FDA approval for a single 30-day period in a limited patient population.
About The Spanner Stent
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 (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.
About SRS Medical
SRS Medical is dedicated to improving the health and well-being of men experiencing LUTS. The company, based in Billerica, Mass., does this by delivering innovative, cost-effective tools to urologists, enabling them to better diagnose and treat these patients. For more information about SRS Medical: http://www.srsmedical.com.