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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 HereCONSERVE® 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).
- The cup replaces the damaged surface of your hip socket
(acetabulum).
- The cap covers the ball-shaped bone at the top of your
thigh (femoral head), and the cap has a small stem that is
inserted into the top of your thighbone.
The cap moves within the cup. The surfaces that rub against
each other (the bearing couple) are made from highly-polished
metal. This type of bearing couple is called a
metal-on-metal bearing couple.
When is it used? The CONSERVE® Plus Total
Resurfacing Hip System relieves hip pain and improves hip
function by replacing the parts of your hip that have been
severely damaged by degenerative joint diseases. Degenerative
joint diseases include osteoarthritis, rheumatoid arthritis,
traumatic arthritis, dysplasia, or avascular necrosis.
The CONSERVE® Plus Total Resurfacing Hip System is intended
for patients who, due to their relatively younger age or
increased activity level, may not be suitable for traditional
total hip replacement due to an increased possibility of
requiring future hip joint revision.
What will it accomplish? The CONSERVE® Plus
Total Resurfacing Hip System is intended to relieve pain and
improve hip function.
When should it not be used?
- Patients with active or suspected infection in or around
the hip joint.
- Patients who are skeletally immature.
- Patients with bone stock inadequate to support the
device including:
- Patients with severe osteopenia should not receive
the CONSERVE® Plus Total Resurfacing Hip procedure.
Patients with a family history of severe osteoporosis or
severe osteopenia;
- Patients with osteonecrosis or avascular necrosis (AVN)
with greater than 50% involvement of the femoral head
(regardless of FICAT Grade) should not receive a
CONSERVE® Plus Total Resurfacing Hip System device; or
- Patients with multiple cysts of the femoral head
(greater than1cm) should not receive a CONSERVE® Plus
Total Resurfacing Hip System device .
- NOTE: In cases of questionable
bone stock, a Dual-Energy X-ray Absorptiometry (DEXA)
scan may be necessary to assess inadequate bone stock.
- Patients with any vascular insufficiency, muscular
atrophy, or neuromuscular disease severe enough to
compromise implant stability or postoperative recovery.
- Females of child bearing age due to unknown effects of
metal ion release on the fetus.
- Patients with known moderate or severe renal
insufficiency.
- Patients who are immunosuppressed with diseases such as
AIDS or persons receiving high doses of corticosteroids.
- Patients who are obese and/or with a BMI greater than
35.
- Patients with known or suspected metal sensitivity (such
as with jewelry).
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