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 (SUI) or to treat vesicoureteral reflux (VUR).  Durasphere has been used by physicians to sucessfully treat SUI and VUR since 1999.

Features and Intended Benefits

• Exceptional Agent Delivery
  Durasphere is designed to flow more easily down the delivery needle to reduce delivery obstruction
• Biocompatible
  Pyrolytic carbon coating has been used for 40 years in the heart valve industry.
• Convenient
  No skin test is necessary. No refrigeration of the product is required.
• Needle and Syringe Options
  Durasphere is available in both 1mL and 3mL syringe volumes. Multiple needles are available to support both a transurethral or submucosal delivery technique.

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 refer to the Directions For Use for a complete list of the potential adverse events associated with urethral bulking.

For more information please contact customer service at 651-653-8512