SRS Medical Systems said it won approval from South Korea’s Korea Food and Drug Administration 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 medical community has long recognized that urinary catheters cause significant medical complications, including urinary tract infections, and diminish patient quality of life. 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,” CEO Lee Brody said in prepared remarks.
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.
The FDA approved Spanner in October 2014 for a single, 30-day period in a limited number of patients, Billerica, Mass.-based SRS said.