This approval makes COPAL® G+C the first bone cement from Heraeus Medical with the combination of two antibiotics (gentamicin and clindamycin) to be certified in accordance with the MDR.
‘The certificate is another important milestone for us to be able to continue to supply our customers with our high-quality and proven products in order to ensure the best possible care for patients,’ says Nicole Petermann, President of Heraeus Medical. ‘Especially in the current challenging situation in which the medical technology industry finds itself due to the transformation to the strict MDR requirements, we are all the more pleased that another important existing product from Heraeus Medical has received certification.’
COPAL® G+C is an antibiotic-loaded bone cement for infection management in arthroplasty. In combination, both antibiotics may target up to 90% of all pathogens typically found in PJI.1
1 Berberich CE, Josse J, Laurent F, Ferry T. Dual antibiotic loaded bone cement in patients at high infection risks in arthroplasty: Rationale of use for prophylaxis and scientific evidence. World J Orthop 2021; 12(3):119–28.
