Device Dossier

MONOVISC® Cross linked Sodium Hyaluronate - Synovial fluid supplementation substance

Device Dossier for MONOVISC® Cross linked Sodium Hyaluronate - Synovial fluid supplementation substance (Synovial fluid supplementation substance, Class…

Intended purpose

MONOVISC is indicated as a viscoelastic supplement or a replacement for synovial fluid in human knee, hip, shoulder and ankle joints. MONOVISC is well suited for treatment of the symptoms of mild to moderate osteoarthritis of the human knee, hip, shoulder and ankle joints for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

Functional description

MONOVISC® Cross-Linked Sodium Hyaluronate Injection is a single, intra-articular injection of cross-linked sodium hyaluronate designed to treat the symptoms of osteoarthritis. The actions of MONOVISC® are lubrication and mechanical support.

TGA Public Summary