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.
As with most surgical procedures, serious adverse events, some of which may be fatal can occur. Although, the STAR system is designed to minimize these risks as much as possible, potential serious risks of the procedure include, but are not limited to:
- Anaphylaxis (life threatening allergic reaction) and death
- Pulmonary embolism (blood clots in the lungs)
- Thermal damage to surrounding tissues
- Nerve injury resulting in radiculopathy, paresis or paralysis
- Pneumothorax or Hemothorax
- Unintended puncture wounds