On label use for The Spanner Stent has been extended to an indefinite sequence of 30-day uses for a large, needy patient population.
BILLERICA, MA., October 12, 2022 – SRS Medical Systems, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval to expand the indications for use of its Spanner® Temporary Prostate Stent1. Previously indicated for a single, 30-day period for post-BPH procedure care, the new indication is for an indefinite sequence of 30-day uses for male patients who are not currently candidates for traditional benign prostate treatments and have bladder function.
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 (UTI), 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.
Clinical evidence submitted to the FDA to support the labeling update included data from 107 men enrolled at 8 sites in the United States; 82/107 (76.6%) completed the trial, and 79/107 (73.8%) successfully maintained PVR ≤ 150 ml for the trial duration. The published data2 demonstrates that “catheter-dependent men with sufficient bladder contractility can achieve volitional voiding and successful bladder drainage using The Spanner Temporary Prostatic Stent for extended periods of time”. The longest patient in the trial entered the Continued Access Protocol and was tracked for 15 months with a PVR ≤ 150 ml at each visit. 68% of the patients who successfully completed the trial underwent a BPH de-obstructive BPH procedure within six months of trial participation completion.
“The Spanner Stent has proven to be a safe, effective, and well-tolerated alternative to catheters for patients following BPH procedures,” stated Dr. Richard Roach, Urologist at Advanced Urology Institute, Oxford, FL, USA, and a principal investigator for the trial. “This extended use safety data and FDA labelling expansion allows access to millions of underserved patients who require catheterization for effective bladder emptying.”
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., designs, manufactures and markets innovative, cost-effective tools for urologists, enabling them to better diagnose and treat these patients. For more information about SRS Medical: www.srsmedical.com.
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1. ClinicalTrials.gov Identifier: NCT02643849
2. Cambio AJ, Roach RM, Arnold P, Cambio J, Gluck CD, Heron SP. Extended Use of The Spanner® Temporary Prostatic Stent in Catheter-Dependent Men with Comorbidities. Advances in Urology. 2022 Feb 3;2022.