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| OsteoRemedies® Obtains Expanded Indications for SPECTRUM® Dual Antibiotic Bone Cement | ||
| By: PR Newswire Association LLC. - 23 Apr 2024 | Back to overview list |
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MEMPHIS, Tenn., April 23, 2024 /PRNewswire/ -- OsteoRemedies® LLC, an orthopedic company focused on providing simple solutions to complex disorders, has announced FDA clearance for expanded indications for the SPECTRUM® GV Bone Cement. The expanded indication covers the fixation of revision hip arthroplasty components, implanted in the second stage of a two-stage revision after the initial infection has been cleared.
Initially launched in 2018, SPECTRUM® GV Bone Cement is the first commercially available dual antibiotic bone cement on the US market. Containing both vancomycin and gentamicin, SPECTRUM® GV Bone Cement prevents bacterial adhesion of susceptible organisms, intermediate-resistant, and methicillin-resistant staphylococcal infections. The clinical effectiveness of dual antibiotics have been a research interest of Dr. James Browne, M.D. of Charlottesville, Virginia. "Several studies have documented the synergy of elution and increased antibacterial activity when dual antibiotics are added to cement. Until now, we have not had a premixed option for dual antibiotic coverage in our cement," said Dr. Browne. From a mechanical performance perspective, testing of SPECTRUM® GV Bone Cement has been compared to commercially available single antibiotic bone cements and found to have substantially equivalent mechanical integrity. The reliable mechanical performance enables its use beyond the original indication, as highlighted by Dr. Michael Meneghini, M.D. and CEO of Indiana Joint Replacement Institute. When asked about the unique value SPECTRUM® GV Bone Cement brings to joint revision patients, Dr. Meneghini commented, "Revision hip and knee arthroplasty patients are increasingly at high risk for MRSA. Vancomycin coverage in the cement provides added protection against PJI in those high risk patients" About OsteoRemedies®, LLC Forming in 2013, OsteoRemedies®, LLC provides simple solutions to complex musculoskeletal disorders. Their first introduction was the REMEDY® Spacer System, the first available modular system for hip, knee and shoulder two-stage infection revision arthroplasty. The REMEDY® Spacer System and REMEDY SPECTRUM® GV Hip Spacers are indicated for temporary use (maximum 180 days) as an adjunct to total joint replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin and vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organisms. Other products offerings include OSTEOBOOST® Select Bone Void Filler, UNITE® AB Bone Cement, and BIOBRUSH™ Powered Debridement Device. Contact
SOURCE OsteoRemedies 
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