Johnson & Johnson has announced that DePuy Synthes, which produces cementless hip implants, has obtained 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 three million hip arthroplasties have been registered in Europe since 1975. 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% and 25%, 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%.
Aaron Villaruz, vice president and global platform leader for hips at Depuy Synthes, said: “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.
In 2018, DePuy Synthes announced a distribution agreement with Société d’Etude, de Recherche et de Fabrication (SERF), an orthopaedics company with experience 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.
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 with DePuy Synthes hip stems, including the market-leading Corail Hip System with more than 2.5 million implantations to date. Sharing in the French design legacy, Corail is backed by registries of peer-reviewed clinical evidence documenting more than 350,000 Corail implantations with a 93.7% survivorship rate at 30 years.