Durasphere® - The new Durasphere® Injectable Bulking Agent is composed of pyrolytic carbon-coated beads suspended in a water-based carrier gel. Durasphere® is indicated for the treatment of adults with stress urinary incontinence due to intrinsic sphincteric deficiency or to treat vesicoureteral reflux (VUR).

Features and Intended Benefits

Instructions for Use
Refer to the Directions For Use for complete instructions.

Contraindications
Durasphere®
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®
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.


For more information about Durasphere®, contact Carbon Medical Technologies at 651-653-8512 or info@carbonmed.com