Biomet starts tennis elbow trial
This article was originally published in Clinica
Executive Summary
Biomet Biologics has completed enrolment of 230 patients in the trial of its Recover platelet separation kit. This kit processes a sample of a patient's blood to produce autologous platelet-rich plasma to treat chronic lateral epicondylitis, also known as tennis elbow. The randomised, double-blind trial is being performed under a US FDA-approved Investigational Device Exemption (IDE) and is expected to conclude in mid-2011. Study participants will receive either the Biomet treatment or the local anaesthetic bupivacaine. The researchers will assess adverse events, severity of pain and arm function. The data from this pivotal study will support an approval submission to the US FDA. Biomet Biologics is a subsidiary of Warsaw, Indiana-based Biomet.