Pain Palliation of
MR-guided focused ultrasound can provide a non-invasive and radiation-free treatment option for the pain palliation of metastatic bone cancer. This treatment has been shown to provide pain relief, an improvement in quality of life and a reduction in the need for pain medication in certain patients who have failed, who are not eligible for or who refuse radiation therapy.¹
Ultrasound waves target the nerves, passing through skin, muscle, and fat. At the point where the ultrasound waves converge, heat is generated. This heat ablates, or destroys, the nerves at the outermost layer of the affected bone, reducing the sensation of pain. Pain relief is usually felt within a few days enabling patients to return to normal activity.
Important Safety Information
Short Term Risks – Day of Treatment up to 2-Weeks Post-Treatment
The most common potential risks associated with the Exablate device and procedure is pain and discomfort related to the delivery of energy during treatment. Occasionally, patients may experience post-procedure pain which can last a few days. Other risks include position-related pain which can happen 1 -3 days post treatment and is usually resolved quickly. There may be a possibility of skin burn occurring on the day of treatment with red skin patches or even 2-3 degree burns. Moderate to severe skin burns should heal and fade within 7-14 days. There is also the risk of Deep Venous Thrombosis after the procedure that must be treated urgently. Blood may appear in urine or the patient may have a bladder or a kidney infection, which can appear within days to a week after the procedure, but can be resolved with antibiotics.
Long Term Risks – Longer than 2-Weeks Post-Treatment
Infrequent complications that have been reported following the Exablate treatment include the possibility of scar formation after skin burn and possible numbness. If a nerve was damaged (unintended), there may be muscle weakness, numbness, or sensory loss that may resolve after several months, or it may be non-reversible. Bone fractures may occur at any time as a result of the bone metastases weakening the bone, prior radiation therapy, or the Exablate procedure.
For additional safety information, please refer to Pre-Market Approval (PMA) P110039
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