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 is injected sub-mucosally at the bladder neck. The injection of Durasphere 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
should not be used in patients with bladder neck or urethral strictures. The safety and effectiveness of Durasphere 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.

Durasphere EXP is distributed in the United States by Boston Scientific Corporation.

For more information please contact Boston Scientific customer service at 1-888-272-1001