Important Safety Information RF Ablation for Bone Tumors

OSTEOCOOL RF ABLATION SYSTEM

The OsteoCool RF Ablation System is intended for:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
• Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy

CONTRAINDICATIONS:

• Use of the OsteoCool^TM RF Ablation System is contraindicated in patients with heart pacemakers or other electronic device implants
• Use of the OsteoCool RF Ablation System device is contraindicated in vertebral body levels C1-C7

ADVERSE EVENTS:

• Adverse events associated with the use of this device are similar to those indicated for medicated and anesthetic methods utilized in other surgical procedures
• Damage to surrounding tissue may occur
• Nerve injury including thermal injury, puncture of the spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis
• Pulmonary embolism. (Blockage of an artery in the lung)
• Hemothorax or pneumothorax (collapsed lung)
• Infection including deep or superficial would infection
• Unintended puncture wound including vascular puncture and dural tear
• Hemorrhage
• Hematoma (clotted blood within tissue)
• Pain