BILLERICA, Mass.--(BUSINESS WIRE)--SRS Medical Systems Inc. today announced that the first patients have been enrolled in a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) study to expand the indications for use for its Spanner® Temporary Prostatic Stent.
The Spanner, the only prostate stent on the U.S. market, is an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients. Currently approved by the FDA for a single 30-day period in a limited patient population, the completely internal device eliminates bladder outlet obstruction while maintaining continence in men with symptoms of urinary retention. The Spanner allows patients to naturally fill and empty their bladders, reduces the risk of urinary tract infection and improves patient quality of life.
“The Spanner often has a transformational effect on the health and well-being of our patients,” said Lee Brody, CEO of SRS Medical. “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.”
The expanded indication from the new study is expected to allow for long-term use of The Spanner in all patients who are not candidates for traditional prostate treatments. Outside of the U.S., The Spanner additionally serves as a tool to confirm bladder contractility and help minimize medical complications in patients awaiting procedures for benign prostatic hyperplasia (BPH).
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.
