Wright Medical wins FDA PMA for Augment injectable bone graft

Wright Medical (NSDQ:WMGI) said today it won FDA premarket approval for its Augment injectable bone graft. The bone graft won clearance for the same indications as the Amsterdam-based company’s non-injectable Augment bone graft. The newly cleared Augment Injectable consists of both recombinant human platelet derived growth factor and a blend of Type I collagen and beta tri-calcium phosphate, the company said. “In Canada, my colleagues and I have been using Augment Injectable since 2011 based upon its ideal handling characteristics and impressive clinical results.  FDA approval of Augment injectable provides a valuable enhancement to the existing Augment product line for U.S. foot and ankle surgeons as a front-line biologic alternative that drives the biological healing process and eliminates the costs and clinical impacts of autograft harvesting,” Dr. Timothy Daniels of Toronto’s St. Michael’s Hospital said in a prepared statement. Wright Medical said that it is hopeful that the US launch of the Augment Injectable will result in sustained growth in the US for its Augment regenerative solutions platform. The company added that it is immediately beginning the finalization of its packaging carrying the FDA approved label, and is hopeful it will begin selling the product in the US shortly with a complete rollout in the next four to six weeks. “Building on the commercial and clinical success of Augment Injectable in the Canadian and Australia...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Orthopedics Pre-Market Approval (PMA) Regulatory/Compliance wrightmedical Source Type: news