SAN FRANCISCO, CA – (February 8th, 2012) – 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™ Antioxidant Polyethylene, RECLAIM™ Modular Revision Hip System, GRIPTION® TF Acetabular Augment System, GLOBAL® UNITE™ Platform Shoulder Arthroplasty System and GLOBAL® STEPTECH® Anchor Peg Glenoid (APG). DePuy is also introducing the latest generation of TRUMATCH® Personalized Solutions technology for use with its SIGMA® 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® COMPLETE® 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™ 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® delta, the fourth generation of BIOLOX ceramic. Its three previous versions have been used in millions of implants throughout the world.[i] 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
Approved for use with the SIGMA Rotating Platform Knee System and LCS® COMPLETE® Mobile Bearing Knee System, the new AOX Polyethylene delivers an advanced blend of polyethylene resin and a unique antioxidant, COVERNOX™, 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.[ii], [iii], [iv] 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 patient’s unique pathology while simplifying the instrumentation required in surgery.
DePuy’s 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, [v] 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. [vi]
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 patient’s 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.
[i] CeramTec. “BIOLOX delta – Nanocomposite for Arthroplasty: The Fourth Generation of Ceramics.” p. 4.
[ii] Data on File at DePuy Orthopaedics, Inc. WR070300.
[iii] Data on File at DePuy Orthopaedics, Inc. WR070248.
[iv] Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM Designation: F648-00
[v] Data on file at DePuy. Operating room time includes preparation, operating room, and turnover time.
[vi] 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.