Durasphere® EXP - The new Durasphere® EXP injectable Bulking Agent is composed of pyrolytic carboncoated beads suspended in a water-based carrier gel. Durasphere® EXP is indicated for the treatment of adult women with stress urinary incontinence due to the intrinsic sphinteric deficiency. Durasphere® EXP is injected sub-mucosally at the bladder neck. The injection of Durasphere® EXP creates increased tissue bulk and subsequent coaption of the bladder neck and/or the urethra. Urinary Incontinence affects approximately 13 million Americans.
Features and Intended Benefits
Instructions for Use
Refer to the Directions For Use for complete instructions.
Durasphere® EXP must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infections.
For single use only. Do not reuse, reprocess or resterilize. Do not inject Durasphere® EXP into blood vessels. Durasphere® EXP should not be used in patients with bladder neck or urethral strictures. The safety and effectiveness of Durasphere® EXP treatment during pregnancy has not been established.
The treatment procedure carries a small risk of infection and/or bleeding, as do similar urologic procedures.
Please see the Directions For Use for a complete list of the potential adverse events associated with urethral bulking.
For more information about Durasphere® EXP, contact Carbon Medical Technologies at 651-653-8512 or firstname.lastname@example.org