Healthcare Industry News:  computed tomography 

Devices Orthopaedic FDA

 News Release - February 7, 2012

Wright Medical Group, Inc. Announces 510(k) Clearance and Limited U.S. Launch of the PROPHECY(R) INBONE(R) Pre-Operative Navigation Alignment Guides

First-To-Market Pre-Operative Alignment Technology for Total Ankle Replacement

ARLINGTON, Tenn.--(Healthcare Sales & Marketing Network)--Wright Medical Group, Inc. (NASDAQ: WMGI ), a global orthopaedic medical device company, today announced the 510(k) clearance and limited launch of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides for total ankle replacement. Designed for use with the Company’s INBONE® Total Ankle Replacement Systems, the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are now available in select sites in the U.S. through Wright Medical’s specialized foot and ankle sales force. Full U.S. commercial release is anticipated to take place in the second half of 2012.

The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides, along with the INBONE® Total Ankle Replacement Systems and other orthopaedic product solutions, will be on display at Wright’s exhibit booth (#1945) from February 8 to February 10 at the American Academy of Orthopaedic Surgeons (AAOS) 2012 Annual Meeting taking place at the Moscone Convention Center in San Francisco.

Initially developed by Wright Medical for total knee replacement, the PROPHECY® Pre-Operative Navigation Alignment Technology utilizes computed tomography (CT) scans to create patient-specific ankle alignment guides that facilitate the surgeons’ ability to precisely size, place and align the INBONE® Total Ankle Replacement components during surgery.

Gregory Berlet, MD, a foot and ankle surgeon with the Orthopedic Foot & Ankle Center in Columbus, Ohio, performed the first surgical procedure using the new system. “The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides enable me to accurately position the INBONE® Total Ankle Replacement components while providing predictable implant alignment from case to case,” stated Dr. Berlet.

“With this new addition to our growing suite of foot and ankle products, surgeons now have a visual plan that details implant placement in advance of the actual surgery, which can reduce the amount of standard instrumentation required in the operating room and streamline the surgical procedure,” said Robert Palmisano, President and Chief Executive Officer. “We are committed to developing innovative devices to improve patients’ quality of life, as well as surgeons’ experiences while they operate.”

With an estimated 4,000 procedures¹ expected to occur in the United States in 2012, total ankle replacement represents a growing market opportunity to treat the approximately 50,000 people per year in the U.S. who experience severe ankle pain due to end-stage ankle arthritis. Today, approximately half of these patients are treated with ankle fusion, but advances in implant design have made ankle replacement a feasible surgical option for many people. In addition to providing pain relief, ankle replacements can offer patients better mobility compared to fusion.

More information on Wright Medical’s foot and ankle products, including the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides and the INBONE® Total Ankle Replacement Systems, can be found at www.wmt.com/footandankle/.

About Wright Medical

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 more than 60 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit the Company’s website at www.wright.com.

1. “2011 US Markets for Orthopedic Extremity Devices,” published October 2010 by Millennium Research Group, Inc.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

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 2012 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, 2010, under the heading, "Risk Factors" and in Item 1A of Part II of our 10-Qs filed during 2011). 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 Group

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