Facebook Linkedin Pinterest Reddit Twitter
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
1 min.Read

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.

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

0
Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

0
Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

0
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

0
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

0
“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device news and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York
United States
Phone Number: 1.561.316.3330

Exit mobile version