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Cortoss bone augmentation material

Cortoss gun

Cortoss material is an advanced, injectable, synthetic, non-resorbable biomaterial which mimics the mechanical properties of cortical (weightbearing) bone1. Cortoss material was developed to provide an ideal bone augmentation solution for treatment of vertebral compression fractures (VCFs). It has been clinically proven to match the safety and effectiveness of Polymethylmethacrylate (PMMA) for vertebral augmentation.2

Features

  • 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 data267

Cortoss cartridge

Multi-center clinical trials provide the proof:
  • The safety and efficacy of Cortoss material has been demonstrated in three U.S. clinical investigations and multiple European studies.267
  • In patients with a first-time fracture at one level, there was a 43% reduction in adjacent level fractures in the patient population that used Cortoss material21
  • Compared to PMMA, Cortoss material is more hydrophilic, which enables it to coat and augment the internal structure of the vertebral body.2 This interdigitating characteristic resulted in a 30% reduction in material injected when compared to PMMA in a controlled study2
  • The level 1 IDE Study showed a statistically significant increase in the percentage of patients experiencing a reduction in short-term pain at 3 months and improvement of long-term function at 24 months2

Warning/adverse events

Complications are rare. 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.