DEFLUX is a bulking agent indicated, in Canada, for treatment of adults with stress urinary incontinence (SUI). DEFLUX is a sterile, highly viscous gel of Dextranomer microspheres (50 mg/mL) in a carrier gel of non-animal stabilized hyaluronic acid (15 mg/mL), constituting a biocompatible and biodegradable implant. The Dextranomer microspheres range in size between 80 to 250 microns, with an average size of about 130 microns. The stabilized hyaluronic acid acts mainly as a carrier, leaving the Dextranomer microspheres at the implant site.
Deflux is contained in a single use disposable syringe. The syringe is equipped with a tip cap, plunger and plunger rod. The syringe is terminally sterilized. Deflux is injected submucosally in the urinary bladder in close proximity to the ureteral orifice. The injection of Deflux creates increased tissue bulk thereby providing coaptation of the distal ureter during filling and contraction of the bladder. The Dextranomer microspheres are gradually surrounded by host connective tissue.
Deflux is to be administered only by qualified surgeons experienced in the use of a cystoscope and trained in the technique of subureteric and/or intraureteric injections (with Deflux or other materials).
It is recommended to use the Deflux metal needle (3.7F x 23G tip x 350 mm) for safe and accurate administration of Deflux.
Deflux is also indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
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