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CERAMENT V

CERAMENT with 66 mg vancomycin/mL paste and iohexol for enhanced visibility under fluoroscopy. CERAMENT V is the first and only CE-marked vancomycin-eluting synthetic bone substitute on the market today. It is ideal for use in indications where infection may be present or a concern, because it offers:

Elution that is reliable and consistent

Irrespective of whether CERAMENT V is injected, molded or formed into beads, the elution profile of vancomycin is the same.

The patented mixing and injecting device ensures a homogeneous distribution of antibiotic, whilst the material properties of CERAMENT means that all of this antibiotic is made available for elution and delivered in a controlled fashion.

 

REFERENCES

S038/2013. Data on file, BONESUPPORT AB, Sweden

Lindberg. In vitro characterization of a vancomycin eluting injectable bone graft substitute with examination of concomitant bone remodeling in rabbit. Presentation given at EBJIS 2014.

A neutral pH that doesn't interfere with antibiotic activity

CERAMENT V paste has been designed to have a pH close to neutral pH (6.6 - 7.0), so it does't reduce antibiotic activity. Vancomycin is effective in the pH range 6.4 - 8.

In vitro studies have shown that CERAMENT V discs exposed to Staphylococcus aureus (ATCC 6538) have a clear zone of inhibition for at least 18 days*.

*Note: at this point the zone of inhibition remained over 12mm, but it was no longer feasible to move beads without disintigration.

 

REFERENCES

S006/2013. Data on file, BONESUPPORT AB, Sweden

S016/2013. Data on file, BONESUPPORT AB, Sweden

S038/2013. Data on file, BONESUPPORT AB, Sweden

S061/2012. Data on file, BONESUPPORT AB, Sweden

Lindberg. In vitro characterization of a vancomycin eluting injectable bone graft substitute with examination of concomitant bone remodeling in rabbit. Presentation given at EBJIS 2014.

Vancomycin elution with a high initial peak, that remains above the minimum inhibitory concentration (MIC) for most vancomycin-sensitive microorganisms for at least 28 days in in vitro tests

It is essential to have a vancomycin concentration above MIC for a clinically relevant period of time, and in vitro studies have shown vancomycin elution from CERAMENT V has a high initial peak (>3000mg/L), and remains above MIC for at least 28 days.

 

REFERENCES

S038/2013. Data on file, BONESUPPORT AB, Sweden

Soriano et al. Influence of vancomycin minimum inhibitory concentration on the treatment of Methicillin-Resistant Staphylococcus aureus bacteremia. Clinical Infectious Diseases 2008; 46:193–200

Lindberg. In vitro characterization of a vancomycin eluting injectable bone graft substitute with examination of concomitant bone remodeling in rabbit. Presentation given at EBJIS 2014.

http://emedicine.medscape.com/article/2090484-overview

Colding-Rasmussen et al, In vivo and in vitro evaluation of vancomycin and gentamicin elution from bone graft substitutes, poster at EBJIS 35th Annual Meeting, 2016, Oxford, UK

A high local concentration of vancomycin, without high serum vancomycin levels

In vitro studies have shown that CERAMENT V offers vancomycin levels up to 3,000 times the minimum inhibitory concentration (MIC) for Methicillin-Resistant Staphylococcus aureus (MRSA).

In patients who underwent tumor resection arthroplasty with CERAMENT V implanted into the bone void, the mean blood plasma concentration of vancomycin measured was 0.3µg/mL (range 0.0 – 1.6µg/mL), well below the trough toxicity level of 10-20 µg/mL.

 

REFERENCES

S038/2013. Data on file, BONESUPPORT AB, Sweden

Soriano et al. Influence of vancomycin minimum inhibitory concentration on the treatment of Methicillin-Resistant Staphylococcus aureus bacteremia. Clinical Infectious Diseases 2008; 46:193–200

Lindberg. In vitro characterization of a vancomycin eluting injectable bone graft substitute with examination of concomitant bone remodeling in rabbit. Presentation given at EBJIS 2014.

http://emedicine.medscape.com/article/2090484-overview

Colding-Rasmussen et al, In vivo and in vitro evaluation of vancomycin and gentamicin elution from bone graft substitutes, poster at EBJIS 35th Annual Meeting, 2016, Oxford, UK

REFERENCES

CERAMENT™|V Instructions for use - IFU0017-03

S038/2013. Data on file. BONESUPPORT AB, Sweden

Yang et al. In vitro elution characteristics of vancomycin in a composite calcium phosphate/calcium sulfate bone substitute. HSSJ (2012) 8:129–132.

Lindberg. In vitro characterization of a vancomycin eluting injectable bone graft substitute with examination of concomitant bone remodeling in rabbit. Presentation given at EBJIS 2014.

http://www.rsc.org/Education/EiC/issues/2012March/vancomycin.asp