Biomet, Business Wire, Clinical Orthopaedics and Related Research, DePuy, Food & Drug Administration, Hip Replacement, Orthopedic surgery, Traumatology, UNited States, Warsaw Indiana
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.
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 stability
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.
Technorati Tags: Biomet, Biomet Active Articulation Dual Mobility Hip System
- J&J, Hip Makers Asked by FDA for Data on Metal in Patients (businessweek.com)
- Studies Ordered for Makers of Artificial Hips (nytimes.com)
- Asheboro, North Carolina Residents Banishing Hip Pain with the Help of Top Orthopedic Doctors (bestmedicalpractices.wordpress.com)
- A Tale of Two Specialties (jaycaplan.wordpress.com)
- DePuy Orthopedics Gets FDA Approval For Ceramic-on-Metal Hip Implant Pinnacle CoMplete System – Is This A Potential Replacement for the Other Ones Out There? (ducknetweb.blogspot.com)
- FDA Approves First Ceramic-on-Metal Total Hip Replacement System (nlm.nih.gov)
- Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System (earlsview.com)
Pingback: Visit to the Surgeon Monday 18th July 2011 « Earl's View
Pingback: Techniques In Implementing A Hip Replacement Operation « Earl's View
Pingback: SPecial Surgery Table for Anterior Hip Replacement Operations « Earl's View
Pingback: Earl's View
Pingback: Ceramic Hip Joint Replacement Devices « Earl's View
Pingback: Biomet Receives FDA Clearance for Active Articulation(TM) E1(R) Dual Mobility Hip System « Earl's View
Pingback: Northern Indiana is the major medical products manufacturing centre for the World « Earl's View
Pingback: Longer Cemented Stems Better in Hip Revisions « Earl's View
Pingback: Staple Closure – Greater Than 3 Times The Risk of Infection « Earl's View
Pingback: Bone Cements – Not all Work Well « Earl's View
Pingback: Biomet Reorganization Causes Job Cuts In Europe, Locally « Earl's View
Pingback: How do we sue for a Biomet hip replacement failure? « Earl's View
Pingback: New Research from Biomet « Earl's View
Pingback: Global Orthopaedic Prosthetics Market to Reach US$19.4 Billion by 2015 « Earl's View
Pingback: Cementless Implants Tied to Improved Hip Implant Survival « Earl's View
Pingback: Extracts from Australian Orthopaedic Association National Joint Replacement Registry – Annual Report 2010 « Earl's View
Pingback: Further Patient Problems – in response to NY Times Article « Earl's View