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
MANCHESTER - Researchers here reported that adverse soft tissue reactions
following metal-on-metal hip arthroplasty are typically due to increased wear of
the bearing surfaces, and patients with smaller femoral heads may be
particularly susceptible to these complications.
In an independent center study, David Langton, FRCS, and colleagues in the Joint
Replacement Unit at the University Hospital of North Tees in Stockton, England,
reviewed 155 Birmingham Hip resurfacings (BHR, Smith & Nephew) performed between
2002 and 2009 (mean follow-up, 60 months). They also studied 420 articular
surface replacements (ASRs) and 75 total hip replacements using ASR XL implants
(both DePuy Orthopaedics) with S-ROM stems (DePuy Orthopaedics) with a mean
follow-up of 35 months...
...There were 17 failures of this nature in patients with ASR implants (3.5%)
and no failures in the BHR group...
...Patients who had adverse reactions to metal debris (ARMD) had a mean femoral
size of 45 mm, a mean acetabular angle of 27° and a mean inclination angle of
53°. Among the asymptomatic patients, those numbers were 49 mm, 20° and 48°,
respectively...
..."I think we can say that the most important points are that increased wear
causes more complications, and all hip resurfacing systems are not the same,"
Langton said. "Also, we found that it is an issue of joint size and orientation,
rather than an issue of gender. And size does matter because men with femoral
components less than 49 mm have a 10% incidence of ARMD."
Reference:
Langton D, Jameson S, Joyce T, et al. The incidence of adverse reactions to
metal debris (ARMD) following hip resurfacing with the articular surface
replacement (ASR) and Birmingham Hip Resurfacing systems (BHR). Presented at the
British Orthopaedic Association Annual Congress 2009. Sept. 15-18, 2009.
Manchester.
A hip replacement was supposed to cure Mary Shelton's pain. Instead, the
Bakersfield woman replaced one pain with another.
Shelton and seven other local folks are suing the manufacturer and distributor
of a hip replacement system.
Instead of being pain free, those suing felt strong pains in their groin areas
for months, the lawsuits say...
All the suits are targeting the Durom Hip Resurfacing System. It's manufactured
by Zimmer Inc. of Indiana...
The suits allege that the Durom system is defective because bone and tissues
don't grow into them properly. A cup in the system has to be replaced with parts
from another manufacturer, Faulkner said.
Zimmer stands behind their product. It's not defective, said Irvine attorney
Michelle M. Fujimoto.
In paperwork filed with the court, the company says any problems can be blamed
on the doctors who implanted the product, or on unusual conditions in the
patients themselves...
The Durom system was first sold in 2006.
...the company has reported that about 15,000 have been implanted across the
nation
Sept. 15, 2009
LONDON - Computer-assisted surgery company The Acrobot Co. Ltd. said Tuesday it signed an agreement with Finsbury Orthopedics Ltd. to market its Navigator system alongside Finsbury's Adept hip resurfacing product. The two products will be marketed together to hospitals, Acrobot said. Navigator enables surgeons to place the components used in hip resurfacing more accurately, which can reduce wear and make the implant last longer.
Hip resurfacing is a procedure designed to spare more bone than traditional hip replacements.
Sept. 15, 2009
LONDON - Computer-assisted surgery company The Acrobot Co. Ltd. said Tuesday it signed an agreement with Finsbury Orthopedics Ltd. to market its Navigator system alongside Finsbury's Adept hip resurfacing product. The two products will be marketed together to hospitals, Acrobot said. Navigator enables surgeons to place the components used in hip resurfacing more accurately, which can reduce wear and make the implant last longer.
Hip resurfacing is a procedure designed to spare more bone than traditional hip replacements.
US Hip Resurfacing Implants Market: Product Penetration to Drive Growth
2009-08-14
The US hip resurfacing implants market valued at
$57.3.million in 2008 is forecast to grow by 36% annually for the next seven
years to reach $483 million by 2015
This growth is expected to be driven by an increase in awareness of the
procedure, increasing clinical familiarity among surgeons and a favorable
reimbursement scenario.
The fact that hip resurfacing offers a more natural feel, higher stability and
lesser bone-loss makes it ideal for patients leading an active life.
Increasing awareness of the advantages that this procedure offers, through
campaigns by both the manufacturers and social groups will drive the growth of
the US hip resurfacing market. There has been a steady increase in the awareness
of hip resurfacing, and it’s offering of an active life even after surgery, its
shorter recovery period, lower costs of rehabilitation and its minimal bone loss
factors. These advantages have positioned hip resurfacing as a primary treatment
method for hip ailments.
The increasing incidence of osteoarthritis in the population group of 25-60
years is a major driver for the US hip resurfacing market. The increasing
prevalence, now at 6% of the young patient population, is expected to drive
growth in the US hip resurfacing market. Osteoarthritis, which first appears
between the age of 25 and 40, is a very common disease in individuals aged 70
and above. Before the age 55, it affects men and women equally but after the age
55, the incidence is higher in women. Effectively, the large pool of male
population between the ages of 25-40 with advanced or severe arthritis of the
hip are expected to drive demand for hip resurfacing impalnts.
Smith & Nephew leads the US hip resurfacing market with its Birmingham Hip
Resurfacing (BHR). Released in May 2006, the BHR had the competitive advantage
of being the only available product for a full year until the market launch of
Corin’s Cormet System in July 2007. Smith & Nephew cashed in on the first mover
advantage with innovative marketing, surgeons education and competitive pricing.
Renewed efforts towards capturing distribution channels and increased stress on
surgeons education has allowed Smith & Nephew to capture 75% market share in the
US hip resurfacing market.
Corin’s deal with Stryker for distribution of its Cormet resurfacing system
played a major role in the sales of its device in spite of the late entry into
the US market. Stryker is known to have one of the strongest sales forces in the
US orthopedic devices market. This combined with Stryker’s strong brand identity
as compared to the UK headquartered Smith & Nephew has allowed Corin’s product
to effectively make inroads into the hip resurfacing market in the US.
GlobalData, the industry analysis specialists’ new report, “US Hip Resurfacing
Implants Market: Product Penetration to Drive Growth”, finds that an increasing
incidence of osteoarthritis in the population group of 25-60 years will drive
the growth of hip resurfacing implants market in the US. The report highlights
the trend of traditional Total Hip Replacement (THR) shifting towards Hip
Resurfacing as one of the key market drivers for the US hip resurfacing market.
American Academy of Orthopaedic Surgeons (AAOS)
Creates Independent Organization
07/23/2009
Rosemont, IL
The American Academy of Orthopaedic Surgeons (AAOS)
has incorporated the American Joint Replacement Registry
(AJRR), a nonprofit organization dedicated to collecting
and reporting on hip and knee joint replacement
procedures. AAOS believes this proposed option is a
patient safety best practice.
The goal of a national joint registry is to monitor
device performance, thereby allowing early recognition
of underperforming processes or devices and supporting
continued clinical learning.
"In 2009, AAOS has made great strides in bringing the
American Joint Replacement Registry to reality. We have
now incorporated. And, we currently are in the process
of forming project work groups to tackle data,
governance and oversight issues." said John Callaghan,
MD, first vice president of the AAOS and orthopaedic
surgeon at the University of Iowa.
The AAOS has researched and determined the best
course of action for starting and administering a
national joint registry, one that would include:
privacy safeguards for patients;
legal protections for device makers and
physicians;
a plan to begin capturing data as early as
2010; and
infrastructure to capture at least 90
percent of all procedures.
In 2006, there were more than 1 million hip and knee
replacements performed in the U.S. Of these,
approximately 7.5 percent were revisions, resulting in
77,000 procedures at a cost of more than $32 billion. A
national joint registry will help doctors to more
quickly identify poorly performing products and match
patient procedures and devices to optimize outcomes.
Therefore, the AJRR could help patients and payers save
money and could limit the number of revision (or
secondary) surgeries necessary. Based on the projected
procedures through 2030, the potential savings could
exceed $13 billion over 20 years.
Proposed by the AAOS and related stakeholders, the
AJRR proposal calls for an independent, not-for-profit
organization, funded by the proposing stakeholders --
orthopaedic surgeons, payers, government agencies,
patient groups, hospitals and device manufacturers. The
AJRR is estimated to cost $20 to $25 million to
initiate.
"We now have a chance to put best practices, already
benefiting patients in other countries, to work here in
the U.S. For instance, registries in Sweden, Great
Britain, Canada and Australia have seen up to a 10
percent reduction in revision rates. Even with a modest
2 percent decrease in the U.S. revision rate, this
proposal would yield a savings of $652 million in one
year," said David Lewallen, MD, chair of the AJRR
Project Team and orthopaedic surgeon at Mayo Clinic.
Background: When a patient has a hip or knee
implanted into his body, the device used was chosen by
his orthopaedic surgeon based on the patient’s needs and
lifestyle as well as the device’s performance. A
device’s longevity is one of the factors that would be
monitored by a national joint registry. A joint registry
follows the artificial joint device throughout a
recipient’s lifetime in a database with information
about the patient’s demographics, as well as where and
when the surgery took place.
Smith & Nephew 2Q Net Profit +15%; Deferrals Greater In Young
July 2009
LONDON (Dow Jones) Medical technology company Smith & Nephew PLC (SN.LN)
Thursday July 30, 2009 reported a 15% rise in second-quarter profit, but
said key products like its Birmingham hip resurfacing system are being
disproportionately hit by the recession, as younger people are more likely to
put off surgery than retirees.
Smith & Nephew said sales growth for replacement hips and knees is slow, as
patients continue to put off going under the knife while worries about the
economy persist. Growth in global sales of its knee products was 1% on the year,
while the hip sales declined 1%.
The company said products like its Birmingham hip resurfacing system, or BHR,
and its Journey knee implant have "a greater exposure" to the effects of the
recession because the rate of deferrals for operations is highest among young,
privately-insured patients.
Peers like Stryker Corp. (SYK), Johnson & Johnson (JNJ) and Zimmer Holdings Inc.
(ZMH) have reported a similar softness in the multi-billion dollar a-year market
for new joints.
Smith & Nephew said net profit for the three months to June 28 rose to $118
million from $103 million a year earlier, on revenue down 7% at $926 million.
That's just ahead of analysts' average forecast of about $117 million net
profit.
Linda is a massage therapist from Essex. She had a history of allergic reactions
to cheap metal and as a result of this underwent a metal allergy test following
her initial consultation. The allergy results showed that she was positive to
Nickel and as a result she was recommended a ceramic on ceramic hip resurfacing,
making her the first person to have an implant of this kind inserted. She is a
very active person and possesses a black belt in karate.
Here she is interviewed at 2 months post op.
More Information available from the McMinn Center by Clicking here
Summary: A new report by Global Markets Direct,
the business intelligence specialists, finds that
increasing number of individuals are opting for
minimally invasive surgeries and treatment options.
Artificial joints, spinal implants and
orthobiologics are some of the key segments driving
revenue growth and investor interests in the global
orthopedic devices sector. Global Markets Direct’s
report, “The Future of the Orthopedic Devices Market
to 2012”, highlights this development as one of the
key market driver for the global orthopedic devices
market.
Artificial Joints Will Continue To Drive Growth
The joint reconstruction (artificial joints)
market valued at $12.2 billion in 2008 will continue
to drive growth in the orthopedic devices sector.
The global joint reconstruction market is expected
to grow by more than 9% annually to reach $17.4
billion by 2012 and is forecast to contribute 45% of
the overall orthopedic devices market value by 2012.
The key growth segments within the join
reconstruction sector are gender specific knee
implants; and hip and knee resurfacing product
lines.
The demand for hip and knee replacement procedures
is increasing with a rise in the aging population
and a growing number of younger patients going for
joint arthroplasty procedures. New product
innovations, newer procedure techniques and positive
clinical outcomes of products introduced in the past
four years are some of the key growth drivers in
this sector according to Global Market Direct
analysis.
Spinal Non-Fusion Technologies To Boost Spinal
Implants Growth
The spinal non-fusion devices market valued at
$551 million in 2008 is forecast to grow by more
than 10% annually to reach $792 million by 2012
accounting for 15% of the spinal surgery market
value.
The presence of innovative products and favorable
clinical trial data for spinal non-fusion product
lines are an indication of the superiority of this
technology over existing options. Its advantage over
the traditional spinal fusion techniques, primarily
associated with higher degree of motion
preservation, is fueling the demand and growth of
non-fusion spinal implants.
Orthobiologics Will Continue To Attract
Investment Dollars
Driven primarily by technological innovations and
strategic consolidations, the orthobiologics market
will continue to be in investors’ focus. The
orthobiologics market, valued at $5.4 billion in
2008 is expected to grow by 9.3% annually to reach
$7.5 billion by 2012. Orthobiologics is the fastest
growing segment within the orthopedic devices sector
with more than 100 products at different stages of
clinical development. Global Market Direct analysis
predict increased utilization of orthobiologics such
as bone morphogenic proteins and autologous growth
factors in orthopedic and spine surgeries to drive
segment growth in the next 5 years.
Biodegradable Implants To Bolster Growth In
Trauma Fixation
Biodegradable implants are set to drive growth of
the trauma fixation devices market which was valued
at $2.2 billion in 2008 and is expected to grow by
6.5% annually to reach $2.8 billion by 2012.
With at least 3 high potential biodegradable
implants under clinical development, the
technological landscape is set for significant
change within the trauma fixation devices market.
Superior technology, patient comfort and procedure
simplicity are expected to drive acceptance by
providers and purchasers.
Industry Consolidations Will Continue To Reshape
The Orthopedic Devices Competitive Landscape
The global orthopedic devices market is set to
see heightened consolidation activity, driven
primarily by Mergers & Acquisitions (M&As) in the
joint reconstruction, spinal surgery and
orthobiologics market segments. In 2007-08, a total
of 42 M&A deals were signed in the orthopedic
devices market with joint reconstruction, spine and
orthobiologics companies’ together accounting for
70% of the deal volume, according to Global Markets
Direct’s medical equipment deals database. The
recent devaluation in market worth of small and
mid-cap companies in the orthopedic device sector in
light of the financial crisis is expected to trigger
fresh bouts of consolidation in the next 3-5 year
period.
The Future Will See A Smaller Number of Patients
Going Under The Knife For Orthopedic Procedures
Innovations in minimally-invasive technologies
have enabled patients to now choose alternate
orthopedic procedures instead of the complex and
painful surgical procedures. The hip and knee
implants market is already witnessing this trend.
Knee and hip resurfacing are potential options for
those who are seeking a more conservative
alternative to total joint replacement. This
bone-conserving approach results in a better range
of motion and less risk of dislocation than
traditional total replacement. Increasing awareness
among patient groups and orthopedic surgeons’
familiarity greater with minimally invasive
procedure techniques is likely to positively impact
the growth dynamics of the orthopedic devices sector
in the next 5 years.
The Future of the Orthopedic Devices Market to
2012
Summary
The global orthopedic devices market, over the
years, has emerged as one of the most dynamic
industries in the medical equipment sector. The
industry in the recent past has seen a mega private
equity transaction, multiple large mergers, some
super large acquisition attempts, heavy patent
infringement payouts and multiple high value product
launches.
Global Markets Direct’s “The Future of the
Orthopedic Devices Market to 2012” report provides
key data, information and analysis on the global
orthopedic devices market. The report provides
market landscape, competitive landscape and market
trends information on 7 market categories including
joint reconstruction, spinal surgery, trauma
fixation, orthobiologics, orthopedic braces and
supports, orthopedic accessories, and orthopedic
diagnostic devices. The report provides
comprehensive information on the key trends
affecting these categories, and key analytical
content on the market dynamics. The report reviews
the competitive landscape in terms of mergers and
acquisitions, pipeline products and technology
offerings.
Scope
• The report covers data and analysis on the
orthopedic devices market in the leading geographies
of the world comprising of the United States,
Canada, UK, Germany, France, Italy, Spain, Japan,
China, India, Australia, and Brazil.
• The report covers global market size and company
share data for 7 orthopedic devices market
categories comprising of Orthobiologics, Joint
Reconstruction, Spinal Surgery, Trauma Fixation,
Arthroscopy, Orthopedic Accessories, and Orthopedic
Braces and Supports.
• Annualized market revenues data from 2000 to 2007,
forecast forward for 5 years to 2012.
• The report provides qualitative analysis of market
drivers, restraints, future outlook and challenges
by categories and segments.
• The report also covers information on the leading
market players, the competitive landscape, and the
leading pipeline products and technologies.
• Key topics covered include the global orthopedic
devices M&A landscape, global market landscape in
the nucleus replacement and gender-specific knees
markets and the hip resurfacing market dynamics in
the US.
• The report is built using data and information
sourced from proprietary databases, primary and
secondary research and in house analysis by Global
Markets Direct’s team of industry experts.
