Durasphere® EXP - The new Durasphere EXP Injectable Bulking Agent is composed of pyrolytic carbon coated beads suspended in a water-based carrier gel. Durasphere EXP is indicated for the treatment of adult women with Stress Urinary Incontinence due to 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 refer to the Directions For Use for a complete list of the potential adverse events associated with urethral bulking.

Ordering Information

Durasphere EXP is distributed by Coloplast Corp.

To place an order for Durasphere EXP contact Coloplast Surgical Customer Service at (800)258-3476 or by fax at (866)216-4161.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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     Injection Procedure Videos

• Periurethral

• Transurethral