The FDA granted Wright Medical Group premarket approval for its Augment Injectable Bone Graft.
Here's what you should know:
1. Augment Injectable Bone Graft was approved for the same clinical indications as augment bone graft.
2. Augment Injectable consists of recombinant human platelet derived growth factor and a combination of Type I collagen and Beta tri-calcium phosphate. It is marketed as a safe, effective and easy-to-use alternative to autograft for hindfoot and ankle fusion applications.
3. The U.S. launch of Augment Injectable is expected to grow Wright Medical's Augment Regenerative Solutions platform over the next several years.
4. The injectable form will be reviewed by hospital value analysis committees, and physician education programs will be implemented.
5. The company expects to complete the rollout of the product in the next four to six weeks.
6. Augment bone graft and Augment Injectable help avoid secondary surgical sites for the harvest of autograft tissue.
"Our approved PMA supplement for Augment Injectable builds upon the existing body of evidence supporting the safety and effectiveness of augment bone graft and leverages clinical data from the U.S. and Canada for the injectable formulation," said President and CEO Robert Palmisano.