Drug intelligence / Profile preview

Durasphere FI

Development stage
Discontinued
Lead developer
Carbon Medical Technologies
Administration
Percutaneous
01

Overview

Durasphere FI is an injectable bulking agent developed by Carbon Medical Technologies for the treatment of fecal incontinence. It consists of non-migratory, pyrolytic carbon-coated zirconium oxide beads suspended in a water-based carrier gel. The beads, which range in size from 212 to 500 microns, are designed to provide permanent mechanical bulk to the anal canal, thereby enhancing the closure of the anal sphincter and reducing incontinent episodes. Unlike collagen-based bulking agents, Durasphere is non-biodegradable and does not require skin testing. While the product is FDA-approved for stress urinary incontinence under the name Durasphere EXP, clinical development for fecal incontinence (Durasphere FI) was explored in trials such as NCT00762047, which was terminated.

Brand names
Durasphere FIDurasphere
Other names
carbon-coated zirconium oxide beadspyrolytic carbon-coated beads

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