DePuy Synthes Announces CE Mark for Dual Mobility Hip Replacement System

Johnson & Johnson Medical Devices Companies* today said DePuy Synthes, a leader in the cementless hip implant market,¹ has been informed of the European CE Mark on its new BI-MENTUM 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 3 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 percent³ and 25 percent,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 percent.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 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 percent 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 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 percent survivorship rate at 30 years.⁸
 
References
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