Healthcare Industry News: INBONE
News Release - January 11, 2011
Wright Medical Group, Inc. Announces IDE Approval for Calcaneal Stem Fixation for the INBONE(R) Total Ankle SystemARLINGTON, Tenn.--(Healthcare Sales & Marketing Network)-- Wright Medical Group, Inc. (NASDAQ:WMGI ), a global orthopaedic medical device company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) clinical study to investigate use of the INBONE® Total Ankle Replacement with Calcaneal Stem for treatment of end stage ankle arthritis or revision of a failed ankle replacement with subtalar joint insufficiency.
Thomas H. Lee, M.D. of the Orthopaedic Foot & Ankle Center in Columbus, Ohio and Principal Investigator of the trial commented, “The INBONE® Calcaneal Stem IDE will look at a novel technique to salvage failed ankle procedures. There is rapidly increasing demand for ankle revision surgery, and the INBONE® implant with Calcaneal Stem will be the first ankle prosthesis to provide component fixation into the calcaneus, allowing surgeons to tackle more complex procedures as an alternative to fusion or amputation.”
“We are enthusiastic about working closely with the FDA in executing this critical study,” said Joel Batts, Senior Director of Clinical Affairs for Wright Medical. “This will be the first FDA-approved Investigational Device Study to measure clinical outcomes in a total ankle replacement that utilizes calcaneal fixation. This study enables us to evaluate ankle arthroplasty in a patient subgroup whose only current surgical alternatives are fusion or amputation.”
Wright Medical Group, Inc. is a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle market. The Company specializes in the design, manufacture and marketing of devices and biologic products for extremity, hip and knee repair and reconstruction. The Company has been in business for 60 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit the Company’s website at www.wmt.com.
This press release contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Such risks and uncertainties include the impact of Wright's settlement of the federal investigation into Wright's consulting arrangements with orthopaedic surgeons relating to its hip and knee products in the United States, including Wright's compliance with a Deferred Prosecution Agreement through September 2011 and a Corporate Integrity Agreement through September 2015, and those risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009, under the heading, “Risk Factors” and in Item 1A of Part II of our 10-Qs filed during 2010). Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date of this press release, and we undertake no obligation to update such statements after this date.
Source: Wright Medical
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