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DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility System for Hip Replacement
Dual-mobility acetabular cups increase the stability of the hip implant in patients at high risk of
dislocation, enhancing patient satisfaction and reducing the incidence of costly follow-up
ZUCHWIL, SWITZERLAND – 13 March 2020 – Johnson & Johnson Medical Devices Companies* today announces that DePuy Synthes, a leader in the cementless hip implant market,1 has been informed of the European CE mark on its new BI-MENTUMTM Dual Mobility System for use in patients with a higher risk of dislocation. BI-MENTUM features a standard femoral head articulating within a large polyethylene liner which then swivels within a metal shell. The system is designed to reduce the risk of dislocation, which can impact patient satisfaction and result in later revision costs.
More than three million hip arthroplasties have been registered in Europe since 1975.2 The incidence of instability caused by dislocation after Total Hip Arthroplasty (THA) in the primary and revision setting has been reported to be as high as 7%3 and 25%,4 respectively. Instability can have a significant impact on patients’ quality of life and mobility. In addition to the burden of repeat surgeries, dislocation can also impact costs in a resource-constrained environment. In fact, the surgical treatment of a dislocating THA can raise the cost of hip replacement by 342%.5
“With an increasing number of patients undergoing hip replacement surgery, surgeons need to address a broader range of surgical needs to help their patients stay active and get on with their lives. Securing the CE mark on BI-MENTUM enables us to better serve our customers and patients across Europe with a solution that is designed to make a continued difference in hip replacement,” said Aaron Villaruz, Vice President and Global Platform Leader for Hips at DePuy Synthes.
In 2018, DePuy Synthes announced a distribution agreement with SERF (Société d’Etude, de Recherche et de Fabrication), a French-based orthopaedics company with a long and respected heritage in dual-mobility technology. DePuy Synthes is now bringing the latest dual-mobility acetabular cups, identical to Serf® dual-mobility cups, under its own brand name, BI-MENTUM Dual Mobility. This clinically proven dual-mobility technology has achieved a track record of 100% cup survivorship at 10 years and also an implant milestone of 165,000 cups since 2007.6
BI-MENTUM, currently available in the United States, is scheduled to be available in select European markets in April 2020. This dual-mobility system integrates seamlessly with all DePuy Synthes hip stems with highly polished necks, including the market-leading CORAIL® Hip System with more than 2.5 million implantations to date.7 Sharing in the French design legacy, CORAIL is backed by registries of peer-reviewed clinical evidence documenting more than 350,000 CORAIL® implantations1 with a 93.7% survivorship rate at 30 years.8
Learn more about new BI-MENTUMTM Dual Mobility System here.
1 CORAIL PINNACLE documented implantations in the Registries. DePuy Synthes; 2019. Data on file.
2 Lübbeke A, Silman A.J., Barea C, Prieto-Alhambra D, Carr A.J.. Mapping existing hip and knee replacement registries in Europe. Science Direct. May 2018.
3 Bettin CC et al. Hip instability after total hip replacement. Sem in Arthroplasty 2013; 24(2):94-8.
4 Lu Y, Xiao, H, Xue F. Causes of and treatment options for dislocation following total hip arthroplasty (Review). Experimental and Therapeutic Medicine 18: 1715-1722, 2019.
5 de Palma L, Procaccini R, Socetti A, Marinelli M. Hospital cost of treating early dislocation following hip arthroplasty. Hip Int. 2012: 22 (01): 62-67.
6 Laurendon L, Philippot R, Neri T, Boyer B, Farizon F. Ten-Year Clinical and Radiological Outcomes of 100 Total Hip Arthroplasty Cases with a Modern Cementless Dual Mobility Cup. Surgical Technology International. 2018 Jun 1;32:331-336.
7 Royalty COE Report, CORAIL WW implantations YTD, 2000 - 2019.
8 Jacquot L, Bonnin MP, Machenaud A, Chouteau J, Saffarini M, Vidalain JP. Clinical and Radiographic Outcomes at 25-30 Years of a Hip Stem Fully Coated with Hydroxyapatite. J Arthroplasty. 2018 Feb; 33(2):482-490.
*Comprising the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment
© DePuy Synthes 2020. All rights reserved.