UroViu Corporation, a company based in Bellevue, Washington, won FDA clearance for its Uro-V single-use diagnostic cystoscope. The semi-flexible disposable device is intended for assessing the urethra and urinary bladder in women while reducing the chances of infection and increasing patient comfort.
The system consists of a reusable handle, video processor, and LCD touchscreen display, and a disposable cannula that’s swapped out for every patient. The approach avoids having to disinfect the system. The cannula is covered with a hydrophilic coating, helping to propel it easily through the anatomy while preventing things from sticking to it.
The scope, which includes LED illumination, provides a 140 degree field of view and offers 30 degrees of deflection. A channel is also available to infuse fluids. The cannula is sized at 12 French.
UroViu believes that its scopes can save a lot of time and trouble for clinics, as maintaining, housing, and cleaning conventional cytoscopes requires a lot of work.
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A prospective, observational, single-arm, open-label clinical usability study in subjects who were candidates for office diagnostic cystoscopy has been completed at 2 centers in the USA and a center in Europe (OUS). Cystoscopy with this new system was performed in 64 female subjects who were candidates for diagnostic cystoscopy, who were willing and able to provide consent. All procedures were completed without incident and no adverse reactions were reported.
[P]rincipal investigator, Vijay Goli, MD, FACS, FICS, associate clinical professor at University of Nevada School of Medicine, Chief of Urology, Summerlin Hospital and Southern Hills Hospital, said, “Our group of 12 providers made the decision to change to disposable sheaths after critical review of single-use versus reusable scopes, finding significant advantages clinically and economically: safer for patient, ease of use for staff, decreased preparation time, overall decreased cost to provider, with higher safety margin—faster turnover of procedure room, equipment, improved patient time efficiency, increased revenue—lower overall cost, increased number of cystoscopy procedures per day and I think that Uro-V will further improve the single-use model—better visualization digital vs analog, less risk of scope malfunction, improved prep time even compared to single-use sheath (which still requires cleansing scope prior to overlaying scope), ability to show in real time to patient operative findings.”