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Urocross Expander System
The Urocross Expander System comprises the Urocross Expander Implant which is preloaded in a constrained configuration within the distal section of the Delivery Catheter and is tethered to Delivery Catheter for controlled release. The handle/plunger of the Delivery Catheter controls advancement, deployment, and release of the implant. To provide an access port for the Delivery Catheter and irrigation to the cystsocsope, the Urocross Expander System includes an Irrigation Connector which attaches to the female luer on the cystoscope. Pressurized irrigation line is attached to the Irrigation Connector valve enabling clearing of the visual field within the prostatic urethra.
Details
Device typeBare-metal urethral stent, long-term: A non-bioabsorbable tubular or ring-like device intended to be implanted indefinitely/long-term in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve obstructions from bulbar urethral strictures, benign prostatic hyperplasia (BPH), and/or detrusor external sphincter dyssynergia (DESD). It is made entirely of metal (e.g., Nitinol) and may be meshed to facilitate embedding in the surrounding tissue. It may be inserted with a balloon catheter or may self-expand in situ; disposable devices (non-powered or electronic) dedicated to implantation may be included with the stent.
FDA categoryTemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device ID00860013645113
Catalog numberUES-2018-C1
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional