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Safety Information

Infrequent complications have been reported following Exablate Neuro MRgFUS treatments which are described below:

SHORT TERM RISKS – DAY OF TREATMENT UP TO 3-MONTHS POST-TREATMENT

The most common potential risks associated with the Exablate Neuro device and thalamotomy procedure are transient numbness and tingling. These sensations are typically mild to moderate in intensity and can last as briefly as the length of the sonication or up to several days. Headaches or head pain during sonication and imbalance or unsteady were other potential risks, but most often ended shortly after treatment.

Nausea/Vomiting were also reported in some instances. It is unclear if this is related to medications used during the treatment or the procedure itself.

You may experience bruising in the area of the iv catheter following the procedure similar to that experienced after blood draws. Any bruising should resolve on its own within a week.

You may experience some pain, bleeding or swelling around the pin site location from the stereotactic frame. These should resolve with a little bit of time (approx 1 week).

LONG TERM RISKS – LONGER THAN 3-MONTHS POST-TREATMENT

Overall, Exablate MRgFUS is a reasonably safe procedure for treating Tremor Dominant Parkinson’s Disease with minimal risk. Infrequent complications that have been reported following Exablate treatment include long-term numbness and tingling. Additionally, if (unintended) brain tissue is damaged, there may be muscle weakness, numbness, or sensory loss that may resolve after several months, or it may be non-reversible.

If you experience a blood clot or DVT after the procedure that is not treated urgently, you may have long term complications related to it if it does not resolve quickly. You could have muscle, heart, brain, or lung damage.