Rivermark Medical Announces Completion of Expanded Indication Study for the Flostent System
Clinical study evaluates the opportunity to treat patients suffering urinary retention due to benign prostatic hyperplasia
Rivermark Medical, a company dedicated to developing a novel therapeutic device for benign prostatic hyperplasia (BPH), announced today the successful completion of its RAPID-UR study, an extended indication study that evaluated the use of the Company’s FloStent System in patients suffering urinary retention due to BPH. The pilot study included 11 patients, and procedures were performed by Drs. Ingrid Perscky and Ruben Urena at the Pacifica Salud Costa del Este Hospital in Panama City, Panama.
Urinary retention (UR) refers to a patient’s inability to pass urine, often requiring placement of a temporary indwelling catheter for relief. BPH is the leading cause of obstructive UR, resulting from the enlargement of the prostate which restricts and obstructs the flow of urine. Between 53-65% of acute UR cases are the result of BPH1,2, and patients who have experienced acute UR are at a 56% increased risk for future episodes2. Currently, no catheter-free device treatments for UR are commercially available.
“Urinary retention can be a painful and severe condition for men with BPH,” stated Adam Kadlec, M.D., Co-Founder and CEO of Rivermark Medical, and practicing Urologist at Aurora Healthcare in Milwaukee, Wisconsin. “Surgery is often recommended, but this is daunting for patients and poses significant risks. A consistently effective, outpatient based, minimally invasive device option for patients suffering from urinary retention is sorely needed. We are confident this expanded application of the FloStent System will address this critical unmet need.”
Rivermark’s FloStent System is a uniquely engineered nitinol stent that gently holds the prostatic urethra to restore normal urinary flow and provide rapid relief for patients with BPH. The system can be deployed during an outpatient procedure using any flexible cystoscope, offering a therapeutic intervention at the time of diagnosis with fewer complications and minimal recovery time.
Rivermark’s clinical program includes recently completing the 12-month follow-up for the RAPID-I first-in-human (FIH) clinical study, in which patients with BPH were treated using the FloStent System in Panama City, Panama. Clinical data from the RAPID-I FIH study, along with results from the expanded indication study, RAPID-UR, will be presented at upcoming Urology congresses.