Safety Information and CE Labeling
CE INDICATIONS FOR USE:
Intended for thermal ablation of targets in thalamus, subthalamus and pallidum regions of the brain. Exablate 4000 transcranial MR guided focused ultrasound can be used for the treatment of neurological disorders (Essential Tremors, Tremor Dominant idiopathic Parkinson’s Disease-Unilateral) and neuropathic pain in the brain by heat induced focusing using ultrasound energy under full MR planning and thermal imaging control.
You should have a detailed conversation with your physician regarding complications, also known as adverse events, that you may experience. Insightec-sponsored clinical studies have shown that the most common adverse events associated with this treatment are 1) imbalance/gait disturbance (26% of study patients), 2) numbness/tingling (33%), and 3) headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days. Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9% of study patients), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting. For additional safety information, please refer to FDA Pre-Market Approval (PMA) P150038. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.
Exablate Neuro is not suitable for all patients. Patients who have any of the following should inform their doctor so he can suggest appropriate treatment options for you.
- If you have any kind of metallic implants, such as pacemakers, neurostimulators, spine or bone fixation devices, total joints, metal clips, screws, etc. you may not be a candidate. Any metallic implants must be non-magnetic to prevent injury to the patient from the MR’s strong magnetic field.
- If you are not generally healthy enough to withstand the treatment and lie still in the same position for approximately 3 hours you may not be a suitable candidate for this treatment. Health related issues such as a recent myocardial infarction (heart attack), congestive heart failure (fluid around the heart), unstable angina pectoris (chest pain), or spinal conditions may be issues that you should discuss with your doctor.
- If you have extensive scarring on the scalp, you may not be a good candidate.
- If you have any tumors inside the skull, you may not be a good candidate.
- If you are on dialysis you may not be a good candidate.
- If you have an active infection or severe hematological, neurological, or other uncontrolled disease you may not be a good candidate.
Please discuss all these conditions with your physician so your doctor can properly evaluate your suitability for the Exablate therapy.
- Tell your physician if you have ever experienced allergic reactions to imaging contrast media. Patients who have allergies to MR contrast materials may not be suitable candidates. Both contrast and non-contrast images may be collected for viewing the effects of the thermal ablation. Your doctor may consider other imaging techniques to evaluate the ablation effects.
- Tell your physician of any medication allergies that you may have including and not limited to recent or past medications.
- Your physician will need to perform a full medical evaluation and full review of your medical chart to fully assess your overall condition. This is necessary to ensure a safe and effective Exablate Neuro treatment for your condition.
- Show your physician any scar on your head. Scar tissue is different from surrounding tissue and is more susceptible to heat damage and could cause pain if located in the beam pathway. Alternate beam paths may be available to avoid the scar tissue.
- You will be given a Stop Sonication button before initiating treatment. In the event of pain or patient motion, activate the stop sonication button so that you will not be harmed. If you are experiencing pain, tell your physician so he can alter the treatment, or alter the pathway to minimize the pain, slow the sonications down to allow for longer heat dissipation times, or provide medication to make you more comfortable. Failure to communicate this with your physician could result in serious injury. The Stop Sonication button is a safety feature built into the system for the patient.
- Tell your physician of all medications you take and of any risks or tendencies you may have for blood clots. Due to the period of immobilization required for the Exablate Neuro treatment, the risk of a blood clot forming can increase because you must lie still for so long during this treatment. If your risk for blood clots is high, your medical team may perform additional tests and prescribe additional medications during the procedure that may avert any potential problems. Compression stockings or other measures may be taken to minimize this risk which is no different than any other procedures with similar durations.
- Tell your physician of any medical conditions you have that could affect your ability to lie on the table for long periods of time. Medical conditions could include neck or back problems (herniated discs or pinched nerves), severe arthritis, etc.
- A stereotactic frame will be attached to your skull by the neurosurgeon to prevent movement during the treatment, but it is still recommended that you remain still during each sonication. Cool water will be circulated around your skull to prevent any burning. You may also be given medication to increase your comfort during the treatment. You will be given a Stop Sonication button before the treatment starts which you will hold during the treatment. If you experience great pain or discomfort, push the button to stop the treatment and tell your physician why you stopped it. Your feedback will allow your physician to make adjustments and address your issue.
RISKS OF HAVING THIS DONE
- Infrequent complications have been reported following Exablate Neuro 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.
LONG TERM RISKS – LONGER THAN 3-MONTHS POST-TREATMENT
- Overall, Exablate Neuro is a reasonably safe procedure for treating essential tremor with minimal risk. Infrequent complications that have been reported following Exablate Neuro 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.