ARLINGTON, Tenn. (AP) – Wright Medical Group Inc. said Thursday that the Food and Drug Administration did not approve its application to use its Augment Bone Graft product as an alternative product for use in foot and ankle fusions.
The Arlington, Tenn., company was seeking approval for use of its product as an alternative to use of a patient's own tissue, a method known as an autograft.
The FDA letter said that the agency was uncertain any graft material would be needed in the "low-risk" patients undergoing the procedures that Wright had studied. As a result, the FDA letter stated that it would be necessary to perform a new clinical study that evaluates the use of Augment Bone Graft as a substitute for autograft in a well-defined high-risk target population, where the use would be clinically warranted.
"Needless to say, we are very disappointed by the FDA's decision to issue a not approvable letter," Robert Palmisano, president and CEO of Wright said in a statement. "This is not what we expected."
Palmisano said the company believed it had addressed all the FDA's concerns from a prior denial letter in an amendment submitted last year.
"We are continuing to study the FDA's position and expect we will work collaboratively with the agency to determine an appropriate path forward," he added.
Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.