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Wright Medical Group NV receives premarket approval for injectable bone graft for hindfoot, ankle fusion
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Wright Medical Group N.V. announced that it has received premarket approval from the FDA for the Augment injectable bone graft for the same clinical indications as the Augment bone graft, according to a company press release.
“Building on the commercial and clinical success of Augment injectable in the Canadian and Australian markets, this important milestone allows Wright to expand our proven Augment franchise and meet the needs of foot and ankle surgeons in the United States with a safe and effective alternative to autograft that includes significantly improved handling characteristics to enable easier and more precise delivery to the fusion site,” Robert Palmisano, president and CEO of the company, said in the release. “In addition to the significantly improved handling characteristics with Augment injectable, one of the key differentiators continues to be the strength of the clinical evidence. Our approved [premarket approval] 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.”
The Augment injectable is comprised of recombinant human platelet-derived growth factor and a blend of type I collagen and beta tri-calcium phosphate, which reportedly offers a clinically proven, safe and effective alternative to autograft that may be used in hindfoot and ankle fusion.
According to the release, the company will start the process of finalizing the packaging with the FDA-approved labeling and anticipates it can begin to sell the Augment injectable in the United States soon and will complete the roll out in the next 4 to 6 weeks.
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