Healthcare Industry News: Hip Resurfacing System
News Release - November 9, 2009
Wright Medical Group, Inc. Receives FDA Approval to Market CONSERVE(R) Plus Total Hip Resurfacing System
ARLINGTON, Tenn.--(HSMN NewsFeed)--Wright Medical Group, Inc. (NASDAQ: WMGI ), a global orthopaedic medical device company, announced today that the United States Food and Drug Administration (FDA) has given approval to the Company to market its original CONSERVE(R) Plus Total Hip Resurfacing System. Now available in the United States, this innovative total surface arthroplasty system provides surgeons and their patients a bone-conserving alternative to traditional total hip replacement.The approval permits Wright to market CONSERVE(R) Plus in the original femoral and acetabular component configuration specified in its PreMarket Approval (PMA) application and enables the Company to initiate efforts to introduce additional enhancements to the system which are currently only available outside of the United States. The Company intends to incorporate these innovative future product options into the CONSERVE(R) Plus System’s femoral and acetabular component offerings via the PMA Supplement pathway.
Hip resurfacing may be ideal for young, active patients in need of surgical treatment for chronic pain. The CONSERVE(R) Plus system is designed to offer pain relief and restoration of function while retaining as much healthy bone as possible and preserving future surgery options, including a primary total hip replacement.
The approval follows a successful clinical trial involving more than 1,300 patients, including those enrolled under Continued Access protocols, providing patient data of CONSERVE(R) Plus clinical data in postoperative periods of up to eight years in length. Wright will commence surgeon training in the first phase of its U.S. introduction. The training is expected to begin immediately upon approval.
“Hip resurfacing represents a valuable alternative to younger, more active patients who desire a hip reconstruction that more anatomically mimics the natural hip,” commented Patrick Fisher, Sr. Director of Marketing for Wright’s hip franchise. “We have learned that this is an excellent option for patients who meet the criteria for hip resurfacing, and these individuals tend to be very enthusiastic and outspoken about their positive results.”
About Wright
Wright Medical Group, Inc. is a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics. The Company has been in business for more than 50 years and markets its products in over 60 countries worldwide. For more information about Wright Medical, visit our website at www.wmt.com.
Safe Harbor
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking 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. The Company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in the Company’s filings with the Securities and Exchange Commission (including the Company’s annual report on Form 10-K for the year ended December 31, 2008, under the heading, “Risk Factors”), which could cause the Company’s actual results to materially differ from those described in the forward-looking statements. Although the Company believes that the forward-looking statements are accurate, there can be no assurance that any forward-looking statement will prove to be accurate. A forward-looking statement should not be regarded as a representation by the Company that the results described therein will be achieved. The Company wishes to caution readers not to place undue reliance on any forward-looking statement. The forward-looking statements are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statement after this date.
Source: Wright Medical
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