This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Gel-One®
PMA Applicant: Seikagaku Corporation
Address: 6-1, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-0005, Japan
Approval Date: March 22, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/p080020a.pdf
What is it? Gel-One® is a hyaluronate hydrogel produced from chicken combs, in a phosphate-buffered saline solution. Gel-One® is a single treatment regimen.
How does it work? Gel-One® is a viscosupplementation device, which is injected directly into the space of the knee joint.
When is it used? Gel-One® is used to relieve knee pain due to osteoarthritis. It is used for patients who do not get enough relief from non-steroidal anti-inflammatory drugs (NSAIDs), or from simple pain medicines, such as acetaminophen, or from exercise and physical therapy.
What will it accomplish? Gel-One® is designed as a single injection treatment to reduce pain associated with osteoarthritis of the knee for up to 13 weeks. Side effects may include pain in the knee at the injection site, stiffness, fluid, swelling or warmth in or around the knee, changes in the way that you walk, such as limping.
When should it not be used?
- Do not administer Gel-One® to patients with a known allergy (hypersensitivity) to Gel-One® or to sodium hyaluronate preparation.
- Do not inject Gel-One® in the knees of patients with infections or skin diseases in the area of the injection site.
Additional information : Summary of Safety and Effectiveness and labeling are available online.