COPAL® G+V is the second bone cement from Heraeus Medical with the combination of two antibiotics (gentamicin und vancomycin), that has been certified according to the requirements of MDR. In March 2024 Heraeus Medical has already received the MDR approval for the dual antibiotic-loaded bone cement COPAL® G+C (gentamicin and clindamycin).
We are proud that the majority of our product portfolio has already met the strict MDR requirements and expect more products to be certified during this year.
COPAL® G+V is an antibiotic-loaded bone cement for infection management in arthroplasty. The combination of both antibiotics offers a broad spectrum of activity against pathogens clinically relevant for periprosthetic joint infections (PJI), including MRSA/MRSE.1
1 Gelbe Liste Wirkstoffe Gentamicin (in vitro data); EMA Assessment Report Vancomycin (in vitro data); Brodt, HR. Antibiotika-Therapie: Klinik und Praxis der antiinfektiösen Behandlung. Stuttgart: Schaattauer Verlag, 2012: 136; 189 (in vitro data); Pfister W., Eick S. Testing the effectiveness of antibiotic admixtures in PMMA bone cements, 2010 (in vitro data); Cara et al. Antibiotics in Bone Cements Used for Prosthesis Fixation: An Efficient Way to Prevent Staphylococcus aureus and Staphylococcus epidermidis Prosthetic Joint Infection. Front. Med., 2010 (in vitro data); Zimmerli W. Bone and Joint Infections. 2015; 132. (in vitro data).
Heraeus Medical GmbHPhilipp-Reis-Str. 8-1361273 WehrheimGermany
