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This is looks like a really exciting development – will follow with interest.

Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System

WARSAW, Ind.– 4/26/2011 (BUSINESS WIRE)– Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, today announced clearance of its Active Articulation(TM) E1(R) Dual Mobility Hip System, by the United States Food and Drug Administration.

The Active Articulation(TM) Hip System is Biomet’s first hip system in the United States to merge the concept of dual mobility with the benefits of Biomet’s exclusive E1(R) Antioxidant Infused technology and a proven cup design1.

Biomet Duel Mobility Active

The dual mobility hip concept was developed over 30 years ago2 and has since experienced clinical success.2,3 The concept utilizes a small femoral head that articulates within polyethylene. The large polyethylene bearing, when triggered, acts as a large head bearing that articulates within a metal cup.

“The Active Articulation(TM) Hip System provides an excellent combination of wear resistance and implant stability,” said Jon Serbousek, President of Biomet’s U.S. Orthopedics division. “We believe this new product will provide an important implant solution to orthopedic surgeons performing hip replacement surgery.”

About Biomet Biomet, Inc. and its subsidiaries design manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non surgical therapy. Biomet’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and softgoods and bracing products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.

Active Articulation™ Dual Mobility Hip System

Dislocation is second to infection as the main early complication following THA.1 Dual mobility constructs have demonstrated long-term clinical success in Europe reducing risk of dislocation1-6 The Active Articulation™ E1® Hip System defines the next generation of dual mobility constructs as it is specifically indicated for patients at risk for dislocation8 and the only dual mobility system to utilize Antioxidant Infused Technology.

  • Dislocation Resistance
  • Ultra-Low Wear – 95% less wear than traditional THA, even when cup is at 60º inclination7
  • Large Range of Motion – Provides up to 165 degrees7
  • Oxidative Stability – E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene.9
  • Clinically Proven Cup10 – The fully-hemispheric M2a-Magnum™ cup contains clinically proven PPS® coating11 and fins to provide fixation and stabilityactive2.jpg

1. Farizon, F. et al. Results with a cementless alumina-coated cup with dual mobility. A twelve-year follow-up study. International Orthopaedics. 22(2):219-24, 1998
2. Langlais, F.L. et al. Dual mobility cemented cups have low dislo¬cation rates in THA revisions. Clinical Orthopaedics and Related Research. 466:389-95, 2008.
3. Philippot, R. et al. The use of a dual-articulation acetabular cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 15 years. International Orthopaedics. 33:927-32, 2009.
4. Guyen, O. et al. Use of a dual mobility socket to manage total hip arthropalsty instability. Clinical Orthopaedics and Related Research. 467:465-72, 2009.
5. Philippot, R. et al. Prevention of dislocation in total hip revision sur¬gery using a dual mobility design. Orthopaedics and Traumatolology: Surgery and Research. 95:407-13, 2009.
6. Massin, P, Besnier L, Acetabular revision of total hip arthroplasty using a press-fit dual mobility cup. Orthopaedics and Traumatology: Surgery and Research. 96:9-13, 2010.
7. Data on file at Biomet. Bench test results not necessarily indicative of clinical performance.
8. See biomet.com for package insert.
9. FDA Cleared Claim. See biomet.com/e1 for complete claim language.
10. Ongoing, multi-center study demonstrated 99.6% survivorship at 2.5 yeas. Data on file at Biomet.
11. McLaughlin, J.R. and Lee, K.R. Survivorship at 22 to 26 Years Reported with Uncemented Tapered Total Hip Stem. Orthopedics Today. 30(1): 1, 2010.

 

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