The Wright Conserve Plus device is no longer available in the US
ARLINGTON, Tenn.-(BUSINESS WIRE) – Nov. 9, 2009 – 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® 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® 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® 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® 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® 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 http://www.wmt.com/conserveplus/
View Original FDA Approval by Clicking Here CONSERVE® Plus Total Resurfacing Hip System – P030042 This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: CONSERVE® Plus Total Resurfacing Hip System PMA Applicant: Wright Medical Technology Address: 5677 Airline Road, Arlington, Tennessee 38002 Approval Date: November 3, 2009 Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030042a.pdf What is it? The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because only the surface of the ball (femoral head) is removed to implant the femoral head resurfacing component. How does it work? The CONSERVE® Plus Total Resurfacing Hip System has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).