SRS Medical Systems 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 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 FDA approved Spanner in October 2014 for a single, 30-day period in a limited number of patients, Billerica, Mass.-based SRS said. The new investigational device exemption from the federal safety watchdog is for a 103-patient study examining unrestricted, long-term use of the device in all patients who are not candidates for traditional prostate treatments, the company said.
“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,” CEO Lee Brody said in prepared remarks. “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.”
“We have been using the Spanner for several years in a limited patient population,” added Dr. Shahin Tabatabaei of the Harvard Medical School and Mass. 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.”