BONESUPPORT’s antibiotic-eluting product, CERAMENT V, has received categorization as a Breakthrough Device for the indication bone infection by FDA.
CERAMENT V is an injectable synthetic bone void filler comprising 40% hydroxyapatite, 60% calcium sulfate and the antibiotic vancomycin hydrochloride.
The ratio of hydroxyapatite and calcium sulfate is designed to enable CERAMENT to resorb at the same rate that bone forms. Calcium sulfate acts as a resorbable carrier for hydroxyapatite, and hydroxyapatite is highly osteoconductive, promoting bone ingrowth.
The addition of vancomycin protects against colonization by vancomycin-sensitive microorganisms.
The characteristics of CERAMENT V mean that surgeons can manage bone defects in a more patient-friendly single-stage procedure. Moving to a single-stage from a multi-stage surgical protocol also frees healthcare resources to meet other needs, paving the way for a more cost-effective strategy for hospitals.
CERAMENT G has previously received breakthrough device designation for the indications bone infection and trauma.
Source: BONESUPPORT
BONESUPPORT’s antibiotic-eluting product, CERAMENT V, has received categorization as a Breakthrough Device for the indication bone infection by FDA.
CERAMENT V is an injectable synthetic bone void filler comprising 40% hydroxyapatite, 60% calcium sulfate and the antibiotic vancomycin hydrochloride.
The ratio of hydroxyapatite and calcium...
BONESUPPORT’s antibiotic-eluting product, CERAMENT V, has received categorization as a Breakthrough Device for the indication bone infection by FDA.
CERAMENT V is an injectable synthetic bone void filler comprising 40% hydroxyapatite, 60% calcium sulfate and the antibiotic vancomycin hydrochloride.
The ratio of hydroxyapatite and calcium sulfate is designed to enable CERAMENT to resorb at the same rate that bone forms. Calcium sulfate acts as a resorbable carrier for hydroxyapatite, and hydroxyapatite is highly osteoconductive, promoting bone ingrowth.
The addition of vancomycin protects against colonization by vancomycin-sensitive microorganisms.
The characteristics of CERAMENT V mean that surgeons can manage bone defects in a more patient-friendly single-stage procedure. Moving to a single-stage from a multi-stage surgical protocol also frees healthcare resources to meet other needs, paving the way for a more cost-effective strategy for hospitals.
CERAMENT G has previously received breakthrough device designation for the indications bone infection and trauma.
Source: BONESUPPORT
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.