Durasphere

Manufacturer: Carbon Medical Technologies

Product details

Durasphere is composed of pyrolytic carbon coated graphite beads suspended in a water-based carrier gel (2.8% Glucan). Pyrolytic carbon-coated graphite beads will not be degraded by the body, so the bulking effect is maintained, and the procedure does not need to be repeated annually, like other bulking agents.

Efficacy

• 5 year follow-up shows efficacy is maintained
• 65% of patients (42/65) maintained improvement in Continence Grade from year 2
• 71% of patients (39/55) considered their symptoms had “improved” or “remained the same” by year 5

Safety

DURASPHERE is effective and well tolerated with an excellent safety profile. Over 100,000 procedures have taken place worldwide. DURASPHERE offers surgeons a long term, less invasive support for the urethra:

• When conventional surgery has not been fully effective
• Where the patient is not fit enough for surgery or anaesthesia
• Where the patient would prefer not to undergo invasive surgery
• When the patient has not yet fully completed her family

NICE Guidelines in Urinary Incontinence suggest considering intramural bulking agents, including those of carbon coated zirconium beads, for the management of SUI (if conservative management has failed.)

NICE Guidelines, Urinary Incontinence: The management of urinary incontinence in women (CG171, published September 2013).

Further information

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.
Durasphere® is designed to flow more easily down the delivery needle to reduce delivery obstruction

Long Term Durability
73% of patients who participated in the U.S. IDE study reported that they maintained their 1-year post procedure continence grade at 4.3 years post procedure.

Biocompatible
Pyrolytic carbon coating has been used for 30 years in the heart valve industry.

Convenient
No skin test is necessary. No refrigeration of the product is required.

Contraindications
Durasphere® must not be used in patients with acute cystitis, urethritis, or other acute genitourinary infections.