YARDLEY, Pennsylvania, August 29, 2024 – Heraeus Medical, a global leader in joint fixation and infection management, today announced that the U.S. Food & Drug Administration has cleared COPAL® G+V, the company’s antibiotic-loaded PMMA bone cement with gentamicin and vancomycin to support PJI treatment.
COPAL® G+V is a high-viscosity dual antibiotic-loaded bone cement containing the antibiotics 0.5g of gentamicin and 2g of vancomycin per 40g unit. This combination is effective against most pathogens related to periprosthetic joint infections (PJI), including MRSA/MRSE*. COPAL® G+V provides a high local antibiotic elution at the surgery site and a low systemic burden for the patient. Since 2012, COPAL® G+V has been used successfully in several regions around the world (including Europe and Australia), enabling orthopedic surgeons to provide patients with added protection of the implant during infection management in arthroplasty procedures.**
Scott Druhot, Vice President of Marketing and Clinical Education for Heraeus Medical USA, said, “Revisions for PJI are devastating to patients and very costly to healthcare systems. Now that COPAL® G+V is launched in the United States, it will be a great addition to our PJI portfolio and reflects our commitment to being an innovator and a leader in infection management.”
Dr. Emily Hunt, Medical Science Liaison for Heraeus Medical USA, noted that dual antibiotic-loaded bone cement provides multiple benefits: “There is not just the effect of two synergistically eluting antibiotics, but a more homogenous antibiotic dispersion in the bone cement compared to manual admixing. Additionally, COPAL® G+V retains its mechanical properties despite the increased antibiotic load. High-viscosity COPAL® G+V is designed to be used like any other cement, avoiding the messy handling and variability that comes with manually adding antibiotics.”
For more information on COPAL® G+V, please visit www.heraeus-medical-usa.com or call 1.833.PALACOS (725-2267).
*MRSA: Methicillin-resistant Staphylococcus aureus / MRSE: Methicillin-resistant Staphylococcus epidermidis
** Indications vary by regulatory authority
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