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Wright Medical Group, Inc. Receives FDA Approval to
Market CONSERVE(R) Plus Total Hip Resurfacing System
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
www.wmt.com. |
