Biomet Announces Completion of Clinical Trial Enrollment for Study Using the Recover® Kit to Treat Chronic Tennis Elbow
Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, LLC, has completed the required 230 subject enrollment for its Recover® Kit clinical trial. This clinical trial studies the use of the Recover® Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis). This multicenter, prospective, randomized, controlled, double-blind clinical trial will be completed when the last subject enrolled reaches 24 weeks follow-up in mid-2011. Enrollment was completed by twelve investigational sites in the United States.
The clinical trial is being performed under a U.S. Food and Drug Administration (FDA)‐approved Investigational Device Exemption (IDE) to evaluate the safety and efficacy of the Company’s Recover® Kit to treat chronic tennis elbow. Study subjects received either the investigational PRP treatment or an active control (bupivacaine). Adverse event profiles and clinical assessments of pain and function will be compared in the two treatment groups. The clinical data from this pivotal study will support a submission to the FDA requesting approval to market the Recover® Kit to treat chronic tennis elbow.
“We are excited to complete the required enrollment for this study, as it addresses a very problematic issue for the patient and surgeon alike,” said Stuart Kleopfer, President of Biomet Biologics. “We believe this is an important step forward in advancing the use of autologous, point-of-care therapies to treat chronic tendinopathies.”
Chronic tennis elbow is the most commonly diagnosed condition of the elbow. It is painful and typically afflicts patients between the ages of 35 and 50 years whose activities require strong gripping or repetitive wrist movements. Along with pain, this condition can result in disability and considerable time lost from work.
Biomet, Inc. and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non‐surgical therapy. Biomet’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and soft goods and bracing products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.
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Bill Kolter, 574-372-1535
Corporate Vice‐President, Government Affairs,
Public Affairs and Corporate Communication