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Cortoss Bone Augmentation Material
We developed Cortoss Material to provide an ideal bone augmentation solution for treatment of vertebral compression fractures (VCFs).
Cortoss is an advanced, injectable, synthetic, non-resorbable biomaterial which mimics the mechanical properties of cortical (weightbearing) bone1. It has been clinically proven to match the safety and effectiveness of Polymethylmethacrylate (PMMA) for vertebral augmentation.2
Flow and fill: properties improve short-term pain and long-term function2
Safety: low incidence of adjacent fractures2; minimal exotherm3 and monomer release4
Control: procedural flexibility with mix-on-demand and start/stop delivery5
Robust compilation of clinical data2,6,7
Warning/adverse events
Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
- An Evaluation of the Safety and Efficacy of an Alternative Material to Polymethylmethacrylate Bone Cement for Vertebral Augmentation
- Bae, H., et al, A Prospective Randomized FDA-IDE Trial Comparing Cortoss to PMMA for Vertebroplasty: A Comparative Effectiveness Research Study with 24-Months Follow-Up. Spine, first published on July 5, 2011 as doi: 10.1097/ BRS.0b013e31822ba50b.
- Deramond H, Wright NT, Belko‑ SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone, 1999. Vol 25 (2) 17S-21S.
- Pomrink, et al., Evaluation of the reaction kinetics of Cortoss, a thermoset cortical bone void ller. Biomaterials, 2003, Vol. 24 (6) 1023-1031.
- Cortoss Bone Augmentation Material: Instructions for Use (IFU)
- Palussière, Jean et al. "Clinical Results Of An Open Prospective Study Of A Bis-GMA Composite In Percutaneous Vertebral Augmentation". European Spine Journal 14.10 (2005): 982-991. Web. 18 Aug. 2016.
- Bae, Hyun et al. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web. "Clinical Experience Using Cortoss For Treating Vertebral Compression Fractures With Vertebroplasty And Kyphoplasty". Spine 35.20 (2010): E1030-E1036. Web.
1000-025-852 Rev None