WARSAW, Ind.--(BUSINESS WIRE)--Biomet, a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, has enrolled the first subject into its multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial for critical limb ischemia (CLI). The trial is being performed under an FDA-approved Investigational Device Exemption (IDE) and is intended to evaluate the safety and efficacy of the company’s MarrowStim™ P.A.D. Kit to prevent or delay major amputation and/or death in subjects with CLI due to severe peripheral arterial disease (P.A.D.). The investigational treatment utilizes autologous bone marrow aspirate, concentrated at the point of care with the MarrowStim™ P.A.D. Kit, and delivered intramuscularly to the affected limb.
