Zimmer Biomet Holdings' Gel-One Cross-linked Hyaluronate has been approved by the U.S. Food and Drug Administration.
The FDA approved an expanded 26-week efficacy claim for the single-injection viscosupplement product, which is to be used for treating knee pain associated with osteoarthritis.
The product can be administered by a physician in office and will be used on patients who did not see results when undergoing non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen.
"Gel-One Hyaluronate is a vital component in the continuum of treatments for knee osteoarthritis, offering millions of patients the potential for up to six months of pain relief with a single injection," Zimmer Biomet Group President David Nolan said in a statement. "The expanded efficacy claim not only strengthens our competitive positioning, but reinforces our commitment to alleviating pain and restoring mobility for patients at every stage in the continuum of musculoskeletal care, including conservative and non-surgical options."
Zimmer Biomet is a leader in musculoskeltal health care. It operates in more than 25 countries and sells products in more than 100.
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