Zimmer Biomet Announces Expanded FDA Safety Claim for Gel-One® Cross-Linked Hyaluronate

Innovative joint preservation treatment for knee osteoarthritis deemed safe and appropriate for repeat use

Dec 01, 2015, 16:02 ET from Zimmer Biomet

WARSAW, Ind., Dec. 1, 2015 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, is pleased to announce an expanded safety claim from the U.S. Food and Drug Administration (FDA) for Gel-One® Cross-linked Hyaluronate, indicating that this single-injection viscosupplement for the knee joint is safe for use in repeat treatments.  Gel-One Hyaluronate is administered in the physician office setting and is indicated for knee osteoarthritis patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or simple analgesics, such as acetaminophen1.

"Our expanded FDA safety claim for Gel-One Hyaluronate is an exciting development for our growing portfolio of joint preservation treatments, as well as the millions of patients who can benefit from this simple, in-office solution for chronic knee pain," said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, and Foot and Ankle.  "Zimmer Biomet is committed to alleviating pain and restoring mobility for patients at every stage of the continuum of musculoskeletal care, including conservative and non-surgical options.  By enabling physicians to administer Gel-One Hyaluronate over multiple treatment cycles, we can offer patients a new option for longer-term osteoarthritis management."

Gel-One 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 Hyaluronate supplement the natural HA of the knee, which provides lubrication to the joint.  Gel-One Hyaluronate requires only a single 3 mL injection to complete the treatment course.  The expanded safety claim from the FDA will enable physicians to safely utilize repeat treatment courses, if required, to provide continued pain relief for patients.

For more information about Gel-One Hyaluronate, visit the Zimmer Biomet booth at the Orthopaedic Summit Evolving Techniques meeting in Las Vegas, December 2-5, 2015.

1Important Safety Information

Before using Gel-One Hyaluronate, ask your patients if they are allergic to hyaluronan products, cinnamon, or products from birds such as feathers, eggs, and poultry. Gel-One Hyaluronate is only for injection into the knee, performed by a doctor or other qualified health care professional. Gel-One Hyaluronate injection should not be used in the presence of a skin disease or infection around the area where the injection will be given. Gel-One Hyaluronate has not been tested to show pain relief in joints other than the knee and for conditions other than OA. Gel-One Hyaluronate has not been tested in patients who are pregnant, mothers who are nursing, or anyone under the age of 21.

Strenuous or pro-longed weight-bearing activities after treatment are not recommended. The effectiveness of repeat treatment cycles of Gel-One Hyaluronate has not been established. The side effects most commonly seen after injection of Gel-One Hyaluronate in the clinical trial were knee pain, swelling, and/or knee effusion. These reactions are generally mild and do not last long.  For complete instructions for use, see the package insert and visit www.zimmerbiomet.com.

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; spine, bone healing, 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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