Anal tissue reconstructive material

Definition
A sterile, bioabsorbable substance intended for submucosal injection in the anal canal to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of faecal incontinence; it does not include a local anaesthetic agent. It is in the form of a gel of biosynthesized dextranomer microspheres and hyaluronic acid (HA) derived from bacteria. The material is typically preloaded in a disposable syringe. This is a single-use device.
GUDID devices
2
Last updated
2019-04-02 02:54:12

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850004725016SolestaPALETTE LIFE SCIENCES, INC.Gel 1.0 mL Syringe2019-02-01
00365649850035Solesta®SALIX PHARMACEUTICALS, LTD.10850032014-10-31