STAR™ Tumor Ablation System

Indications for Use

The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

 

Risks and Contraindications

As with most surgical procedures, there are risks associated with the STAR procedure, including serious complications. For complete information regarding risks, contraindications, warnings, and precautions, please review the systems’ Instruction for Use.

 

Adverse Events

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur
  • Nerve injury including thermal injury, puncture of the cord or nerve roots potentially resulting in radiculopathy, paresis or paralysis
  • Pulmonary embolism
  • Hemothorax or pneumothorax
  • Infection including deep or superficial wound infection
  • Unintended puncture wounds including vascular puncture and dural tear
  • Hemorrhage
  • Hematoma
  • Pain

 

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