GEL-SYN - P110005
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-SYN
PMA Applicant: Institut Biochimique S.A. (IBSA)
Address: Via del Piano - 6915 Pambio-Noranco, Switzerland
Approval Date: May 9, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005a.pdf
What is it? GEL-SYN is an artificial material that contains sodium hyaluronate and is injected into osteoarthritic knee joint. GEL-SYN is similar to hyaluronic acid found in the knee joint space. GEL-SYN relieves pain from osteoarthritis (OA) and it functions as a lubricant and shock absorber.
Osteoarthritis is a type of wear and tear in joints that causes pain. In patients with OA, there may not be enough hyaluronic acid lubricating the joint space.
How does it work? GEL-SYN is injected directly into the space inside the knee. The treatment consists of three weekly injections.
GEL-SYN relieves pain and functions as a lubricant in patients with moderate osteoarthritis of the knee who have failed conservative treatments from physical therapy and simple pain medicines such as acetaminophen.
When is it used? GEL-SYN is used to relieve pain due to osteoarthritis of the knee in patients who do not get enough relief from simple pain medicines such as acetaminophen or from physical therapy.
What will it accomplish? GEL-SYN relieves pain associated with osteoarthritis for up to 26 weeks. Side-effects may include injection site pain, swelling, or joint pain.
In a clinical study, pain scores were used to compare the effectiveness of the GEL-SYN injections to commercial hyaluronate. It showed that patients receiving GEL-SYN experienced the same amount of improvement in knee pain over 26 weeks as those who received the commercially available hyaluronan.
When should it not be used? GEL-SYN should not be injected into:
- Patients with known hypersensitivity (allergy) to sodium hyaluronate preparations.
- Patients having knee joint infections, skin diseases, or infections in the area of the injection site.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.