Musculoskeletal Clinical Regulatory Advisers (MCRA) announced its role in the successful approvable decision by the US Food and Drug Administration (FDA) for Wright Medical Group,) Augment Bone Graft Premarket Approval Application (PMA), for use as an alternative to autograft for ankle and/or hindfoot fusion procedures.
Wright announced the approvable decision on October 27, 2014.
Wright retained MCRA in August 2013 to re-examine the IDE clinical data, execute an FDA appeal strategy, and lead all interactions and correspondence with FDA for its Augment® Bone Graft PMA application.
Wright and MCRA successfully worked with the FDA to demonstrate the safety and effectiveness of Augment Bone Graft. This is the seventh PMA in which MCRA assisted a client since 2006.
Glenn Stiegman, MCRA’s Vice President of Clinical and Regulatory Affairs, explained, "MCRA had been following the developments of the PMA process closely for Augment® We are pleased Wright asked us to work with them to develop and execute an FDA response strategy to the Not Approvable letter and assist in leading Augment to approvability."
Wright’s President and CEO, Robert Palmisano, added, "We chose MCRA for their extensive orthopedic PMA experience over the past decade. Their depth in regulatory and clinical science made them an excellent partner for working hand-in-hand with our team and the FDA."