Rivermark Medical Reports Expanded Indication Study for FloStent System

Clinical study evaluates the opportunity to treat patients suffering urinary retention due to benign prostatic hyperplasia

Rivermark Medical

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

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.”

FloStent System

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.

Clinical Program

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.
AppliedVR Co-founder and President Josh Sackman, "We're committed to developing a significant body of scientific evidence that demonstrates how our RelieVRx program, which is rooted in self-regulation, cognitive behavioral therapy skills and mindfulness, engages the brain and can impact the experience of pain. While we know there can be a strong placebo effect, this feasibility study showed that only the active RelieVRx treatment created changes at a physiological and brain activity level, creating a strong foundation for future research."
Researchers and clinicians from Emory Winship Cancer Institute collaborated to test their prostate cancer population notes Prevencio.
First patients treated with H-Guard at the National Institute for Health and Care Research Manchester Clinical Research Facility. MHRA approves continuation of Invizius's first-in-human clinical study following a prearranged two-patient safety and performance review. Study is investigating safety and tolerability of H-Guard®, a second generation complement regulator, to address serious immune system-driven complications of dialysis.

By using this website you agree to accept Medical Device News Magazine Privacy Policy