U.S., April 9 -- ClinicalTrials.gov registry received information related to the study (NCT06917365) titled 'Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups' on April 01.
Brief Summary: XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU).
XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with t...