BILLERICA, Mass.--(BUSINESS WIRE)--SRS Medical Systems, Inc., manufacturer of the only prostate stent on the U.S. market, today announced that it has received U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval for a confirmatory safety study to expand the indications for use for its Spanner® Temporary Prostatic Stent. This 105-patient study is being conducted to support a premarket approval (PMA) supplement submission to FDA.
The Spanner is an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients. Unlike urinary catheters, 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.
“By replacing a urinary catheter with a prostate stent, care providers reduce the risk of urinary tract infection, improve patient quality-of-life, and decrease the factors which commonly contribute to higher overall healthcare costs, such as length-of-stay, readmissions and other catheter-related complications,” said Lee Brody, CEO of SRS Medical. “We are delighted to have reached agreement with FDA and, based on our clinical experience with The Spanner, we are confident that we will achieve the clinical safety endpoints established in collaboration with FDA for this confirmatory study.”
Currently, the device is approved by FDA for a single 30-day period in a limited patient population. The expanded indication is expected to allow for unrestricted long-term use of The Spanner in all patients who are not candidates for traditional prostate treatments.
“We have been using The Spanner for several years in a limited patient population,” said Dr. Shahin Tabatabaei, Assistant Professor of Surgery-Urology at Harvard Medical School - Massachusetts General Hospital. “Patients who receive this intra-urethral device instead of a urinary catheter have dramatically lower rates of urinary tract infection and greatly prefer the stent to a catheter. If the IDE study demonstrates long-term effectiveness in a wide patient population, The Spanner could replace urinary catheters as a standard of care in the management of some male patients with retention.”
“The Spanner often has a far-reaching impact on activities of daily living,” added Florida urologist Sarat Sabharwal, M.D., FACS. “The benefits of the stent are immediate and a return to natural voiding often has a transformative effect on emotional well-being and overall health.”
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.