Wright Medical Group, Inc. has announced it received a “not approvable” letter from the FDA in response to its Pre-Market Approval (PMA) application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.
Not for the first time the FDA has knocked back Wright Medical’s PMA submission for its Augment Bone Graft. On this occasion the agency is saying study data pertained to a population that was so low risk as to have possibly not required grafting at all, rendering the results less meaningful than they would have been from a representative population.
That all sounds a bit strange to us, not least because presumably the company and the agency must have at least discussed the requirement after the last rejection. Surely someone at Wright Medical had asked the question? If that’s the case, no wonder the company is sounding a bit tetchy.
Specifically, in the “not approvable” letter, FDA states it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft.” FDA went on to state it believes that “it will be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”
In summary, FDA concerns included “the patient population studied in the clinical study, the amount of graft material implanted, 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.” FDA provided a number of additional observations about the clinical study design and 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,” stated Robert Palmisano, president and chief executive officer of Wright. “This is not what we expected, as we believed that all of the FDA’s concerns as outlined in their previous not approvable letter from December 2011 had been fully and thoroughly addressed in the PMA 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.”
Source: Wright Medical Group, Business Wire