Zimmer Biomet (NYSE:ZBH) touted data today from an investigational device exemption trial evaluating the use of autologous concentrated bone marrow aspirate for the treatment of critical limb ischemia. The stem cell study is the 1st pivotal trial of its kind to complete enrollment and a 1-year follow-up in a patient population that is ineligible for revascularization, the company said.
Warsaw, Ind.-based Zimmer Biomet’s trial is a prospective, randomized, double-blind study of stem cells injected intramuscularly into the affected limb to prevent or delay major amputation or death in patients with critical limb ischemia. The primary efficacy endpoint is the time to major amputation and all-cause mortality at 1 year.
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