TriVisc - P160057
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: TriVisc
PMA Applicant: OrthogenRx, Inc.
Address: Pennsylvania Biotechnology Center, 3805 Old Easton Road, Doylestown, PA 18902-8400
Approval Date: 11/13/2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057a.pdf
What is it? TriVisc is a sterile sodium hyaluronate solution that is used to relieve knee pain due to osteoarthritis. It is injected into the knee join to supplement the viscous (thick) fluid in the knee.
How does it work? A health care professional injects TriVisc into the part of the knee that contains fluid used for lubrication and cushioning the joint. For optimal pain relief, TriVisc is injected as 3 doses, one week apart. Once in place,the TriVisc functions as a physical lubricant inside the knee joint.
When is it used? TriVisc is used to relieve pain due to osteoarthritis of the knee for patients who do not get enough relief from simple pain medicines, such as acetaminophen, or from exercise and physical therapy.
What will it accomplish? Each patient's response to TriVisc may vary, depending on the severity of the osteoarthritis, degree of pain, and pre-existing medical conditions. Reasonable assurance of the effectiveness of TriVisc was not established from clinical data for TriVisc. Instead, the sponsor provided nonclinical comparison studies of TriVisc and a previously approved, commercially available sodium hyaluronate to show that the two devices are very similar. Based upon this clinical data set, patients treated with TriVisc would be expected to experience, on average, a 52% reduction in pain at 12 weeks.
When should it not be used? TriVisc should not be used in patients who:
- have ever had an allergic response to sodium hyaluronate products such as a rash, itching, hives, flushing, swelling of the face, tongue or throat, and/or difficulty breathing;
- have a knee joint infection or skin disease in the area of the injection site;
- have circulatory problems in the legs
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.