SAN FRANCISCO, CA – DePuy Orthopaedics, Inc. (DePuy)
announced the launch of several new advancements in orthopaedics spanning joint
replacement, shoulder reconstruction and hip revision surgery, each designed to
optimize or streamline procedures, personalize care and provide clinical and
economic value. The announcement was made here at the 79th Annual Meeting of
the American Academy of Orthopaedic Surgeons
(AAOS).
New treatment options include AOX (TM) Antioxidant
Polyethylene, RECLAIM (TM) Modular Revision Hip System, GRIPTION (R) TF
Acetabular Augment System, GLOBAL (R) UNITE (TM) Platform Shoulder Arthroplasty
System and GLOBAL (R) STEPTECH (R) Anchor Peg Glenoid (APG). DePuy is also
introducing the latest generation of TRUMATCH (R) Personalized Solutions
technology for use with its SIGMA (R) Fixed-Bearing Knee System, one of the
most widely used knee systems in the world.
“Our ever expanding portfolio enables us to offer solutions
to most of the orthopaedic challenges a surgeon or patient may face,” said
Andrew Ekdahl, President, DePuy Orthopaedics. “Our goal is to provide
surgeons and health care institutions with more choices that help fill clinical
needs, streamline procedures and personalize treatment. We believe that
products that focus on these areas will help enhance care while reducing health
care costs.”
Last year, DePuy received several FDA product approvals and
clearances, including premarket approval (PMA) for AOX Polyethylene, an
antioxidant polyethylene designed for optimal wear resistance and long-term
oxidative stability, and the PINNACLE (R) COMPLETE (R) Acetabular Hip System,
the industry’s first and only ceramic-on-metal hip bearing approved for sale in
the United States.
The PINNACLE Cup System, which has more than 10 years of
documented clinical success and has been provided for more than one million
patients, is the only acetabular cup system on the market with PMA approvals
for both ceramic-on-ceramic and ceramic-on-metal bearing options. The PINNACLE
Ceramax (TM) Ceramic Total Hip System, featuring a new generation of ceramic
material, received its PMA approval in 2010. The all ceramic implant is the
only device in the U.S.
with BIOLOX (R) delta, the fourth generation of BIOLOX ceramic. Its three
previous versions have been used in millions of implants throughout the
world.(1) The PINNACLE System is now the only acetabular cup system with five
bearing options, providing surgeons with a full range of options to meet the clinical
needs of their patients.
AAOS 2012 Launches
AOX Polyethylene
Approved for use with the SIGMA Rotating Platform Knee System and LCS (R)
COMPLETE (R) Mobile Bearing Knee System, the new AOX Polyethylene delivers an
advanced blend of polyethylene resin and a unique antioxidant, COVERNOX (TM),
to create a new polyethylene material that is highly efficient in trapping free
radicals and scavenging oxygen. By eliminating the annealing or remelting
process, AOX Polyethylene delivers oxidative stability and optimum wear
resistance without compromising the mechanical properties or strength of the
polyethylene.(2,3,4) By introducing COVERNOX Antioxidant into the base resin
before the polyethylene is consolidated, the process enables the antioxidant to
be uniformly dispersed and remain blended, eliminating the risk of outward
migration.
Hip Revision Solutions
The RECLAIM Modular Revision Hip System is engineered to deliver a high level
of implant strength. This system has been studied extensively through analytic
techniques and rigorous laboratory testing and has demonstrated promising
capabilities, particularly with respect to construct fatigue strength and
torsional stability. The modular design of the RECLAIM Revision Hip System features
novel instrument technology that may improve intraoperative handling,
flexibility and efficiency. The modularity of the system offers surgeons
numerous options to treat a patients unique pathology while simplifying the
instrumentation required in surgery.
DePuys GRIPTION TF Acetabular Augment System addresses bone
defects in moderate to complex acetabular revision surgery using a highly
porous structure made from commercially pure titanium; a strong,
corrosion-resistant metal that has high surface roughness and a similar
elasticity to bone. The GRIPTION TF System offers a wide range of options and
configurations for the patient at the time of surgery and is designed to work
in conjunction with the full range of PINNACLE Acetabular Cup options.
Procedural Efficiency in Knee Replacement
TRUMATCH Personalized Solutions 2.5i provides enhanced capabilities that aid
implant positioning and procedural efficiency. TRUMATCH, which reduces procedure
time by up to 35 minutes,(5) is the first system to utilize CT scans and
computer software to guide the development and production of femoral and tibial
cutting blocks that are individually prepared to match the actual bone surfaces
of each patient. The use of CT scans, rather than MRIs, results in improved
bone imaging, less scanning time and lower costs.(6)
Advanced Shoulder Solutions
DePuy is launching two new shoulder solutions. The GLOBAL UNITE Platform System,
which treats fractures of the proximal humerus, helps improve tuberosity
healing and is the only system that can later be easily converted to a reverse
shoulder arthroplasty for treatment of arthritis with a torn rotator cuff. The GLOBAL
STEPTECH APG System, has been designed to correct excessive retroversion caused
by posterior glenoid bone loss, closely recreate the original glenohumeral
joint line, and minimize the removal of healthy bone. The prosthesis
incorporates a proprietary step design with an anterior backside surface that
is spherical and a posterior backside surface that is conical. This unique dual
surface design effectively counteracts posterior loading.
Important Safety Information
The performance of joint reconstruction and replacement products depends on a
patients age, weight, activity level and other factors. There are potential
risks, and recovery takes time. People with conditions limiting rehabilitation
should not have these surgeries. Patients should consult with an orthopaedic
surgeon to determine if joint reconstruction and replacement surgery is
appropriate for them.
About DePuy Orthopaedics
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global
provider of orthopaedic devices for hip, knee, trauma and extremities, as well
as bone cement and operating room products. It is part of the DePuy Family of
Companies, which has a rich heritage of pioneering a broad range of products
and solutions across the continuum of orthopaedic and neurological care. These
companies are unified under one vision – Never Stop Moving® – to express their
commitment to bring meaningful innovation, shared knowledge and quality care to
patients throughout the world. Visit www.depuy.com for more information.
(1) CeramTec. “BIOLOX
delta – Nanocomposite for Arthroplasty: The Fourth Generation of Ceramics.” p.
4.
(2) Data on File at DePuy Orthopaedics, Inc. WR070300.
(3) Data on File at DePuy Orthopaedics, Inc. WR070248.
(4) Standard Specification for Ultra-High-Molecular-Weight
Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM
Designation: F648-00
(5) Data on file at DePuy. Operating room time includes
preparation, operating room, and turnover time.
(6) D. White, K. L. Chelule, B. B. Seedhom. Accuracy of MRI
vs CT imaging with particular reference to patient specific templates for total
knee replacement surgery. Int J Med Robotics Comput Assist Surg 2008; 4:
224–231.