CE Mark for BONESUPPORT CERAMENT™|V, Injectable Vancomycin-Eluting Bone Substitute

Bone substitute specialist company, BONESUPPORT, has received CE-mark for CERAMENT™|V, the first injectable vancomycin-eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis.

Background

BONESUPPORT describes itself as an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery.

Its CERAMENT™|V is an extension of the company’s antibiotic eluting bone substitute portfolio which includes CERAMENT™|G, the first injectable gentamicin eluting bone substitute.

So the V stands for Vancomycin, an antibiotic that is used to treat gram-positive bacteria that are known to be resistant to most antibiotics. (Incidentally these includeMethicillin-resistant Staphylococcus aureus (MRSA)). The Infectious Disease Society of America recommends vancomycin as first-line therapy for these complicated infections, which include bone, and joint infections.

CERAMENT™|V is an injectable, resorbable bone graft substitute which remodels into healthy native bone within 6 to 12 months, and is designed to fill bone gaps and voids and can augment hardware and bone fractures during surgical procedures. The efficient elution profile and the focused local delivery of vancomycin obtained with CERAMENT™|V is intended to prevent colonization of sensitive microorganisms, thereby protecting the bone healing, particularly in challenging cases of deep bone infection.

BONESUPPORT is launching CERAMENT™|V immediately in all CE-mark countries.

Physician comments

“Antibiotic resistant infections are among the most challenging clinical conditions to manage,” said Pablo S. Corona, M.D., PhD, from the Reconstructive and Septic Surgery Division, Department of Orthopaedic Surgery, Hospital de Traumatologia y Rehabilitacion Vall d’Hebron, Barcelona, Spain. “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.”

Company comments

“Expanding our portfolio of drug-delivery therapeutics is an important part of our growth strategy and we are proud to be executing on that with the launch of CERAMENT™|V,” said Lloyd Diamond, CEO of BONESUPPORT. “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.”

Source: PR Newswire

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