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DJO Global’s Surgical Division Announces the Implantation of the First Blended Vitamin E Total Knee Replacement in the United States

Vitamin E index

SAN DIEGO–(BUSINESS WIRE)– DJO Global, Inc. (“DJO” or the “Company”), a leading provider of medical device solutions for musculoskeletal health, vascular health and pain management, today announced the implantation of the first blended vitamin E total knee replacement in the U.S. The e-plusTM total knee replacement insert component was developed by the Company’s surgical division, DJO Surgical, formerly Encore Medical. E-plus is the first total knee replacement material to be offered to patients in the U.S. with vitamin E blended into the insert component.

In a knee replacement system, an insert component, which is made out of polyethylene, is positioned between the metal femur and tibial replacement components and serves as surface for the femur to articulate, or move, against. Polyethylene wear continues to be a weak point in the long-term success of total knee replacements. E-plus is an innovative, next generation formulation of high density polymer blended with vitamin E, a natural anti-oxidant. Vitamin E improves the material’s strength while preventing polyethylene degenerating oxidation, leading to a reduction in wear. This helps the material hold up to the higher expectations of today’s active patient. E-plus is the first blended vitamin E polyethylene, with the vitamin E homogeneously blended directly into the resin.

The e-plus insert was created for the 3DKneeTM, a knee replacement system designed to improve strength, stability, and flexion in patients. The 3DKnee (Data Driven Design) is based on over a decade of research into total knee kinematics and over 30,000 3DKnees have been implanted world-wide. E-plus now adds a new level of performance to 3DKnee total knee replacement. In laboratory testing, the 3DKnee produced 57% less wear with the e-plus insert compared with the already premium performing Direct Molded insert component currently used in the 3DKnee system. The Direct Molded insert component is individually molded to have a smooth surface. The new e-plus insert component has among the lowest simulated wear rates for a total knee replacement in the U.S.

Dr. Salvatore LaCognata, an orthopedic surgeon in Mesa, AZ, was the first surgeon to implant an e-plus component. “I am very excited to offer our patients the highest level of technology available to maximize benefits in longevity and performance when it comes to knee replacement surgery,” said Dr. LaCognata. “DJO is reaching out to our patients and providing longer lasting components.”

“We are very pleased to be moving orthopedic technology forward with this innovative total knee replacement bearing surface,” said Les Cross, president and chief executive officer of DJO Global. “Active patients are requiring joint replacements at a younger age now and are living longer. With this fact in mind, it is our responsibility to develop stronger and longer lasting materials to improve the quality of life of the patients who receive them. DJO remains dedicated to providing the highest caliber medical devices through constant innovation and excellent customer service.”

Knee Products

DJO Surgical offers a full range of innovative knee products, from partial knee replacement through revision. DJO Surgical feature products include:

e-plus

e-plus™ – Blended to move you >

An appropriately cross-linked polyethylene material, e-plus, a knee specific formula, is blended with vitamin E and formulated to reduce long-term wear.

3dknee prosthesis

3DKnee System >

The 3DKnee™ System is an ACL substituting primary knee system intended to reduce wear, improve patient function and knee strength, and enhance ROM.

Epik Unicondylar Knee Implant

EPIK Unicondylar Knee System >

The EPIK® is an anatomic resurfacing partial knee replacement featuring new sleek minimally invasive instrumentation.

Foundation Knee

Foundation Knee System >

The Foundation® Knee System is a completely modular system from primary cruciate retaining and posterior stabilized to revision.

Minimally Invasive Femoral Cut Block

M.I.K.A.TM Knee Instrumentation

DJO Surgical’s Minimally Invasive Knee Arthroplasty Instrumentation allows the surgeon to make an incision that is optimal to the patient. The system features sleek guides, cut blocks, and handles that encourage a smooth, reproducible surgery for all patients.

Foundation Modular Knee Femoral Component

Foundation Modular Revision System >

The Foundation® Knee System is a completely modular system from primary cruciate retaining and posterior stabilized to revision.

3dmatrix - Encore's porous coating

3DMatrix Porous Coating >

DJO Surgical’s 3DMatrix® porous coating consists of small, three-dimensional (non-spherical) beads. The porous material is either commercially pure titanium or CoCr alloy, depending on the base substrate.

graph of implant compatability with both genders

Gender and Culture >

Research has shown that women have smaller medial-lateral femoral dimensions than men1. This difference is incorporated into the sizing of DJO Surgical’s femoral implants.

Eplus header

e-plus™ – Blended to move you

An appropriately cross-linked polyethylene material, e-plus, a knee specific formula, is blended with vitamin E and formulated to reduce long-term wear1.

Re-Melting not Required

Because vitamin E stabilizes free radicals2, a melt-anneal step is rendered unnecessary.

A re-melt step, used for most highly cross-linked polyethylenes, reduces the mechanical properties and fatigue strength of irradiated UHMWPE2.

ePlus

Blended

e-plus is the only FDA cleared blended vitamin E TKA component. UHMWPE resin is blended with pure liquid α-tocopheral (vitamin E), a naturally occurring anti-oxidant.

No Oxidation

During intense age testing1, e-plus exhibited no detectable oxidation.

Maximum Mechanical Strength1
The impact of oxygen exposure to e-plus samples was evaluated in accelerated aging tests. Un-aged and aged e-plus samples yielded the same results during yield strength testing, while a melt-annealed standard highly cross-linked material exhibited a 12% reduction in yield strength.

IZOD Impact testing, which can indicate the relative brittleness of a material, showed no change in performance between pre and post-aged e-plus.

ePlus

Reduced Wear1
e-plus, when tested on an Instron/Stanmore knee simulator, had a 57% reduction in wear rate than already premium performing direct compression molded UHMWPE.

References

1. E-plus testing data on file. Bench test results not necessarily indicative of clinical performance.

2. S.M. Kurtz. “The UHMWPE Handbook: Ultrahigh Molecular Weight Polyethylene in Total Joint Replacement”. Oral E, Muratoglu OK. Chapter 15, “Highly Crosslinked UHMWPE Doped with Vitamin E”. Elsevier Academic Press, 2009.

About DJO Global

DJO Global is a leading global developer, manufacturer and distributor of high-quality medical devices and services that provide solutions for musculoskeletal health, vascular health and pain management. The Company’s products address the continuum of patient care from injury prevention to rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. Its products are used by orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, Empi®, ProCare® and DJO® Surgical. For additional information on the Company, please visit www.DJOglobal.com.

DJO Investor/Media Contact:
DJO Global, Inc.
Mark Francois, Director of Investor Relations
760.734.4766
mark.francois@DJOglobal.com

Source: DJO Global, Inc.

Copyright Business Wire 2011

 

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