The Use of the UroShield Device in Patients with Indwelling Urinary Catheters
Prepared by: Dagan Haris, Ph.D
Date: October 2010
Version: 2
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This report complies with Guidelines for Industry: Structure and Content of Clinical Trial
Report. ICH E3 E3 www.ICH.org and ISO 14155-1,2:2003
Urology Therapy Device
UroShield is a urology therapy device that is composed of two components:
Disposable Clip – Intended for single use and to be discarded with catheter replacement.
Driver – A portable unit (AC or battery powered) that provides power to the disposable clip.
The ultrasonic waves generated by the clip create an acoustic shield on the surfaces of the catheter to interfere with the attachment of bacteria, prevent bacterial biofilm formation, the development of infections and may eliminate or reduce the need for antibiotics.
UroShield is designed to:
- Prevents biofilm formation
- Decreases bacteriuria/UTI
- Reduces catheter pain and discomfort
- Increases antibiotic efficacy
The clip-on UroShield urology therapy device can be attached to all external urinary tract catheters providing potential relief from spasm and catheter pain.
