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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:

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

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

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.

REFERENCES

CERAMENT™|V Instructions for use - IFU0016-02

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