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