The international medical devices company Biocomposites has announced that its STIMULAN? products have gained European Union Medical Device Regulation (MDR) certification for mixing with a combination of Gram-positive and Gram-negative antibiotics to assist in the treatment of infection in bone and surrounding soft tissue.
The antibiotics include vancomycin, gentamicin and tobramycin, as well as the combination of vancomycin with either tobramycin or gentamicin.
The STIMULAN? Rapid Cure and STIMULAN? Kit products are the only calcium matrices certified to carry a combination of antibiotics and resolve infection.
They offer surgeons the flexibility to apply a broad spectrum of ‘off-the-shelf’ antibiotics to support patient-specific treatment plans.
STIMULAN? can deliver high concentrations of combined Gram-positive and Gram-negative antibiotics to the point of infection at levels unachievable systemically.
This resolves infection and reduces the need for secondary surgery.
STIMULAN? is already approved in more than 60 countries and used by surgeons to help 150,000 patients every year.
Michael Harris, CEO of Biocomposites, said: "Gaining MDR certification, which reaffirms STIMULAN? as the only calcium matrix antibiotic carrier certified for mixing with a combination of Gram-positive and Gram-negative antibiotics and also resolves infection in bone and surrounding soft tissue, is tremendous news."
"Our world-leading calcium sulfate antibiotic carrier is trusted by surgeons across the globe as part of their infection management strategies, helping to improve patient outcomes and decrease hospital readmissions."