Zimmer Biomet Holdings Inc , a global leader in musculoskeletal healthcare announced that the U.S. FDA approved an expanded 26-week efficacy claim for its single-injection viscosupplement Gel-One® Cross-linked Hyaluronate for the treatment of knee pain associated with osteoarthritis.
Gel-One Cross-linked Hyaluronate may be administered in the physician office setting and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, e.g., acetaminophen1.
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“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,” said David Nolan, Zimmer Biomet Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. “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.”
Gel-One Cross-Linked Hyaluronate is the first low-volume viscosupplement available in a single-injection formulation for the treatment of osteoarthritis of the knee. Hyaluronic acid (HA) products such as Gel-One Cross-linked Hyaluronate may supplement the natural HA of the knee, which provides cushioning and lubrication to the joint. Gel-One Cross-linked Hyaluronate requires only a single 3 mL injection to complete the treatment course.
About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit zimmerbiomet.com or follow Zimmer Biomet on Twitter at twitter.com/zimmerbiomet.
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