Swedish biotech firm Bonesupport has secured CE Mark for the first injectable vancomycin eluting bone substitute, Cerament|V, which was developed to promote and protect bone healing in the management of osteomyelitis.
Cerament|V is an injectable and resorbable bone graft substitute designed to fill bone gaps and voids, and can augment hardware and bone fractures during surgical procedures.
Vancomycin was designed to treat gram-positive bacteria, which are resistant to most antibiotics, including methicillin-resistant Staphylococcus aureus (MRSA).
According to the company, the resorbable bone graft substitute can remodel into healthy native bone within six to 12 months.
The new product is an extension to the company's antibiotic eluting bone substitute portfolio, which includes Cerament|G, the first injectable gentamicin eluting bone substitute.
Cerament|V can prevent colonisation of sensitive microorganisms and protect bone healing, specifically in challenging cases of deep bone infection.
Hospital de Traumatologia y Rehabilitacion Vall d' Hebron Department of Orthopaedic Surgery, Reconstructive and Septic Surgery Division Dr Pablo Corona said: "Antibiotic resistant infections are among the most challenging clinical conditions to manage.
"Local, high-dose antibiotic delivery is particularly effective in managing and preventing infections, as seen with Cerament|G.
"Now with the availability of Cerament|V, surgeons have two powerful weapons that address the most common bacteria in the fight against osteomyelitis."
The company said the injectable vancomycin eluting bone substitute, Cerament|V, will be immediately launched in all CE Mark countries.
Bonesupport CEO Lloyd Diamond said: "As a pioneer of antibiotic eluting bone substitute technology, the launch of Cerament|V marks the first ever injectable bone substitute with two drugs, vancomycin and Iohexol, to receive approval."
"This is an important milestone because it paves the way for future drug delivery combinations using our propriety technology and the Cerament platform."