OsteoRemedies receives FDA clearance for expanded indications of antibiotic bone cement
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Key takeaways:
- OsteoRemedies announced FDA expanded indications of its Spectrum GV dual antibiotic bone cement.
- Spectrum GV bone cement is indicated for component fixation during revision THA and two-stage revision THA.
OsteoRemedies LLC announced FDA clearance for expanded indications of its Spectrum GV dual antibiotic bone cement for the use in revision total hip arthroplasty procedures, according to a press release.
The Spectrum GV bone cement, designed with dual antibiotic cement, is now indicated for component fixation during revision THA and two-stage revision THA after initial infection.
“Revision hip and knee arthroplasty patients are increasingly at high risk for MRSA,” R. Michael Meneghini, MD, CEO of the Indiana Joint Replacement Institute and professor of clinical orthopedic surgery at Indiana University School of Medicine, said in the release. “Vancomycin coverage in the cement provides added protection against [periprosthetic joint infection] in those high-risk patients,” Meneghini said.
“Several studies have documented the synergy of elution and increased antibacterial activity when dual antibiotics are added to cement,” James A. Browne, MD, professor of orthopedic surgery at the University of Virginia, said in the release. “Until now, we have not had a premixed option for dual antibiotic coverage in our cement,” he said.
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