SRS Medical Systems said today it enrolled the 1st patients in an FDA investigational device exemption study as it seeks to expand the indications for its Spanner temporary prostatic stent.
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 often has a transformational effect on the health and well-being of our patients. We are excited for our study subjects to experience the wide variety of benefits of eliminating their chronic urinary catheters, and we look forward to working with FDA to offer The Spanner as a long-term solution to U.S. male patients next year,” CEO Lee Brody said in a press release.
The Billerica, Mass.-based company said it is seeking expanded indications to allow for long-term use of the Spanner in all patients who are not candidates for traditional prostate treatments.
In June, SRS Medical Systems said 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.
In March, SRS Medical said it won approval from South Korea’s Korea Food and Drug Administration for the Spanner.