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

临床研究评估治疗良性前列腺增生尿潴留患者的机会

MILWAUKEE, Jan. 8, 2024 /PRNewswire/ -- 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.

密尔沃基，2024年1月8日/PRNewswire/--致力于开发一种新型良性前列腺增生（BPH）治疗设备的Rivermark Medical公司今天宣布，其RAPID-UR研究成功完成，该研究是一项扩展适应症研究，评估了该公司的FloStent系统在BPH尿潴留患者中的使用情况。

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..

这项初步研究包括11名患者，手术由巴拿马巴拿马城Pacifica Salud Costa del Este医院的Ingrid Perscky博士和Ruben Urena博士进行。。

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.

尿潴留（UR）是指患者无法排尿，通常需要放置临时留置导管以缓解。BPH是阻塞性UR的主要原因，这是由于前列腺增大而导致的，前列腺增大会限制和阻碍尿液的流动。53-65%的急性UR病例是BPH1,2的结果，经历过急性UR的患者未来发作的风险增加了56%2。

Currently, no catheter-free device treatments for UR are commercially available.  .

目前，没有用于UR的无导管装置治疗可商购。。

'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.

Rivermark Medical联合创始人兼首席执行官、威斯康星州密尔沃基Aurora Healthcare泌尿科医生亚当·卡德莱克（AdamKadlec）医学博士说，尿潴留对BPH患者来说可能是一种痛苦而严重的疾病通常建议进行手术，但这对患者来说是令人望而生畏的，并且会带来重大风险。

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.'.

迫切需要为患有尿潴留的患者提供持续有效的，基于门诊的微创设备选择。我们相信，FloStent系统的这种扩展应用将解决这一关键的未满足需求。”。

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的FloStent系统是一种独特的工程镍钛合金支架，可轻轻固定前列腺尿道，恢复正常尿流，并为BPH患者提供快速缓解。该系统可以在门诊手术期间使用任何柔性膀胱镜进行部署，在诊断时提供治疗干预，并发症少，恢复时间短。。

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..

Rivermark的临床计划包括最近完成RAPID-I首次人体（FIH）临床研究的12个月随访，其中使用巴拿马巴拿马城的FloStent系统治疗BPH患者。RAPID-I FIH研究的临床数据以及扩展适应症研究RAPID-UR的结果将在即将举行的泌尿外科大会上发表。。

About Rivermark MedicalRivermark Medical was founded by a practicing urologist to develop the preferred first-line device therapy for benign prostatic hyperplasia. The FloStent System enables physicians to treat patients safely and efficiently, with minimal discomfort and reduced complications. The FloStent System includes a nitinol stent placed during an outpatient procedure, that gently holds the prostatic urethra open to restore normal urinary function, preserves sexual function, and improves a patient's overall quality of life.

关于Rivermark Medical Rivermark Medical由一位执业泌尿科医生创立，旨在开发治疗良性前列腺增生的首选一线设备。FloStent系统使医生能够安全有效地治疗患者，同时减少不适和并发症。FloStent系统包括在门诊手术期间放置的镍钛合金支架，该支架轻轻地保持前列腺尿道开放以恢复正常的泌尿功能，保留性功能并改善患者的整体生活质量。

The FloStent System is the first product Rivermark Medical plans to bring to market. For more information, please visit www.rivermarkmedical.com..

FloStent系统是Rivermark医疗计划推出的第一款产品。有关更多信息，请访问www.rivermarkmedical.com。。

Media ContactKatie ArnoldSPRIG Consulting LLC[email protected]

媒体联系人Katie ArnoldSPRIG Consulting LLC[受电子邮件保护]

1 Selius, BA; Sebedi, R. 'Urinary Retention in Adults: Diagnosis and Initial Management'. American Family Physician. 2008;77(5):643-6502 Muruganandham, K; Dubey, D; Kapoor, R. 'Acute urinary retention in benign prostatic hyperplasia: Risk factors and current management'. Indian Journal of Urology. 2007 Oct-Dec; 23(4): 347–353..

1塞利乌斯，BA；Sebedi，R.“成人尿潴留：诊断和初步管理”。美国家庭医生。2008年；77（5）：643-6502 Muruganandham，K；杜比，D；Kapoor，R.“良性前列腺增生的急性尿潴留：危险因素和当前管理”。印度泌尿外科杂志。2007年10月至12月；23（4）：347-353。。

SOURCE Rivermark Medical

来源Rivermark Medical