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 categoryStent, Urethral, Prostatic, Permanent Or Semi-Permanent
Device ID00850081334019
Catalog numberZFS-IMP-18-01
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Stent Length18 Millimeter