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News Briefs: FDA Turns Down Wright’s Augment; Cook Resumes Zilver PTX Shipments; Luminex Restructures

Wright Medical receives not approvable letter for its Augment bone graft asking for another study. Judge rules against Zimmer in favor of Strkyer in patent case. Cook Medical has resolved the problems that triggered a December 2012 recall of its Zilver PTX peripheral stent. Luminex cuts staff, invests in molecular diagnostics efforts.

FDA issued a not-approvable letter to Wright Medical Technology Inc. for its Augment bone graft, the company announced August 8. Wright is seeking PMA approval for Augment as an alternative to autograft in hindfoot and ankle fusion procedures.

FDA says that the clinical data Wright submitted was mostly from low-risk patients who “may not have warranted the use of either autograft or Augment Bone Graft.” To earn approval,...

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