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.

Contraindications
Durasphere® EXP
must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infections.

Warnings
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.

Precautions
The treatment procedure carries a small risk of infection and/or bleeding, as do similar urologic procedures.

Adverse Events
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 info@carbonmed.com