The first patients in a new investigational device exemption (IDE) study to expand indications for SRS Medical Systems‘ Spanner Temporary Prostatic Stent have been enrolled.
The stent is a U.S. Food and Drug Administration (FDA) approved Class 3 device designed to maintain urine flow and allow for voluntary urination in some male patients experiencing lower urinary tract symptoms (LUTS). The FDA approval is limited to a 30-day period and for a limited group of patients.
Photo Credit: Business Wire
The device is made of two anchors and a silicone tube (illustrated in the photo at right) developed to reduce resistance in the bladder neck and prostatic urethra without stenting the external sphincter. The stent is placed blindly without anesthetics, similar to the placement of a Foley catheter.
The device is the only prostate stent available in the U.S. as an alternative to both indwelling (Foley) and intermittent urinary catheters in male patients. The completely internal device allows patients to naturally fill and empty their bladders while reducing the risk of urinary tract infection and improving the patients’ quality of life.
Outside of the U.S the stent serves as a tool to confirm bladder contractility and minimize medical complications in patients awaiting procedures for benign prostatic hyperplasia (BPH).
“The Spanner often has a transformational effect on the health and well-being of our patients,” Lee Brody, SRS Medical’s chief executive officer, said in a press release. “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 study (NCT02643849) is titled “Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men.” Completion is projected for June 2017.
The expanded indication is expected to allow for long-term use of the stent in all patients who are not candidates for standard prostate treatments.
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