A New Treatment Option for Painful Metastatic Spinal Tumors
FDA 510 K Indications for Use statement for this clinical application:
The STAR™ Tumor Ablation System is “indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body”.
Provide Rapid Back Pain Relief
THE STAR Tumor Ablation System is designed and purpose-built for the palliative treatment of metastatic vertebral body lesions.
To receive more information about STAR and see if it is right for your metastatic spine or pain program, please click here
- Provide rapid back pain relief through a minimally invasive, targeted (outpatient) procedure
- Compatible with patients’ current systemic cancer treatments
- Alternative for patients who have reached their cumulative radiation dose limit
- Potential treatment for radio-resistant tumors
- Pain reduction prior to radiotherapy
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The STAR™ Tumor Ablation System is cleared by the FDA for providing palliative treatment (e.g., pain relief) by ablation of metastatic malignant tumors in a vertebral body. Patients undergoing radiofrequency ablation are subject to risks associated with surgery including complications from anesthesia/sedation as well as bleeding, bruising, pain and infection. Additional complications could include: blood clots, collapsed lungs, and damage to normal tissue, nerves, the spinal cord or other structures resulting in injuries including paralysis. Not every patient is a good candidate for the STAR™ Tumor Ablation System. The STAR System is contraindicated for patients with pacemakers or other electronic implants, and for the cervical section of the spine.