vertebral compression fracture

StabiliT® Vertebral Augmentation System

Indications for Use: StabiliT Vertebral Augmentation System

The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER2 Bone Cement. The StabiliT ER2 Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Indications for Use: StabiliT MX Vertebral Augmentation System

The StabiliT MX Vertebral Augmentation System is intended for percutaneous delivery of StabiliT Bone Cement. The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Indications for Use: StabiliT VP Vertebroplasty System

The StabiliT VP Vertebroplasty System is intended for percutaneous delivery of StabiliT Bone Cement. The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Risks and Contraindications

As with most surgical procedures, there are risks associated with the StabiliT procedure, including serious complications. For complete information regarding risks, contraindications, warnings, and precautions, please review the systems’ Instruction for Use. For complete information regarding System related adverse events please see Instructions for Use.

Adverse Events

Serious adverse events, some with fatal outcome, associated with the use of polymethylmethacrylate (PMMA) include:

  • Myocardial infarction
  • Cardiac arrest
  • Cerebrovascular accident
  • Pulmonary embolism
  • Anaphylaxis
  • Diffusion of the bone cement outside the vertebral body: in the peripheral veins (pulmonary embolism), in the epidural plexus (myelopathy, radiculopathy), in the intervertebral disc

The most frequent adverse reactions reported with PMMA are:

  • Transitory fall in blood pressure
  • Thrombophlebitis
  • Hemorrhage and hematoma
  • Superficial or deep wound infection
  • Bursitis
  • Short-term cardiac irregularities
  • Heterotopic bone formation

Other potential adverse events reported for PMMA include:

  • Pyrexia
  • Hematuria
  • Dysuria
  • Bladder fistula
  • Transitory worsening of pain due to heat released during polymerization
  • Nerve entrapment and dysphasia due to extrusion of the bone cement beyond its intended application
  • Adhesions and stricture of the ileum due to heat released during polymerization

Potential adverse events associated with kyphoplasty or vertebroplasty include:

  • Pneumonia
  • Intercostal neuralgia
  • Collapse of a vertebra adjacent to the one injected, due to an osteoporotic disease
  • Pneumothorax
  • Extravasation of bone cement into soft tissue
  • Fracture of a pedicle
  • Rib fracture in patients with diffuse osteopenia, especially during thoracic kyphoplasty procedures, due to the significant downward force exerted during Working Cannula insertion
  • Compression of the spinal cord with paralysis or loss of feeling