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.

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