Wright Medical Gets FDA Not Approvable Letter For Augment Bone Graft

(RTTNews) - Wright Medical Group, Inc. (WMGI) said Thursday that it has received a not approvable letter from the Food & Drug Administration in response to its Pre-Market Approval application for Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

In the 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."

The company said the FDA provided a number of additional observations about the clinical study design and results.