This article is more than 5 years old. Information may no longer be current.
Wright Medical receives not approvable letter for autograft alternative
Click Here to Manage Email Alerts
Wright Medical Group Inc. announced it received a not approvable letter from the FDA in response to its premarket approval application for Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.
In the letter, FDA stated the need to perform a new clinical study to evaluate the bone graft’s use in hindfoot and ankle fusion procedures in a “well-defined high-risk target population, where the use of autograft would be clinically warranted.” The FDA was also concerned with “the patient population studied in the clinical study, the amount of graft material implants, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.”
“Needless to say, we are very disappointed by the FDA’s decision to issue a not approvable letter for our PMA application for Augment Bone Graft,” Robert Palmisano, president and chief executive officer of Wright Medical, stated in a company press release. “This is not what we expected, as we believed that all of the FDA’s concerns as outlined in their previous no approvable letter from December 2011 had been fully and thoroughly addressed in the premarket approval amendment that BioMimetic submitted in June 2012. We are continuing to study the FDA’s position and expect we will work collaboratively with the agency to determine an appropriate path forward.”