SAFETY INFORMATION

You should have a detailed conversation with your physician regarding the risks and benefits of treatment options prior to treatment.

For additional safety information pertaining to the focused ultrasound device, please refer to Pre-Market Approval (PMA) P150038 and the additional links for specific indications provided below.

Essential Tremor – First Side

  • The most common adverse events, or complications, reported by subjects in Insightec-sponsored clinical studies after treatment included: imbalance/gait disturbance (26% of subjects), numbness/tingling (33%), and headache/head pain (51%). The numbers in parenthesis is the percentage of subjects who experienced these adverse events during or after treatment.
  • Complications that persisted at 3 years included: numbness/tingling (9% of study patients), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%).
  • The number in parenthesis is the percentage of active subjects experiencing these adverse events at the 3-year time point.
  • For additional safety information for unilateral Essential Tremor, please refer to Pre-Market Approval (PMA) P150038. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.

Essential Tremor – Second Side

  • The safety profile and risks of the second side treatment are similar to the treatment of the first side.
  • The most common adverse events, or complications, reported by subjects in Insightec-sponsored clinical studies after treatment included: Ataxia (24% of subjects), numbness/tingling (33%), dysarthria (29%), dysgeusia (14%), imbalance (10%), unsteadiness (10%), gait disturbance (10%), dysphagia (10%), hypogeusia (10%). The numbers in parenthesis is the percentage of subjects who experienced these adverse events during or after treatment.
  • 98% of these events were classified as mild (85%) or moderate (13%), and 51% of all adverse events resolved on their own within 6 months.
  • Additional infrequent (<5%) events include dysmetria, fatigue, weakness, decrease in synchronicity, dizziness, dry mouth, hypoesthesia, intermittent diplopia, sialorrhea, voice change, facial droop, headache, and UTI.
  • Complications that persisted in more than 2% of subjects at 6 months included: numbness/tingling (16%), slurred speech (14%), ataxia (14%), hypogeusia (8%), dysphagia (8%), and dysgeusia (6%). The number in parenthesis is the percentage of active subjects experiencing these adverse events at the 6-month time point.
  • One serious event occurred (urinary tract infection following use of catheter during procedure).
  • For additional safety information for Staged Unilateral Treatment of the Contralateral Side, please refer to Pre-Market Approval P150038 Supplement S022. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.

Tremor Dominant Parkinson’s Disease

  • 27% of adverse events reported in Insightec-sponsored clinical studies were classified as thalamotomy- or procedure-related.
  • 95% of all adverse events were classified as mild or moderate, and 71% resolved on their own within 72 hours.
  • Two serious adverse events were reported that resulted in hemiparesis. A root cause analysis led to enhanced training.
  • For additional safety information for Tremor Dominant Parkinson’s Disease, please refer to Pre-Market Approval P150038 Supplement S006. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.

Parkinson’s Disease

  • The most common adverse events, or complications, reported by subjects in Insightec-sponsored clinical studies after treatment included: headache/head pain (32%), nausea/vomiting (7%), hypertension (6%), falls related to Parkinson’s Disease (6%). The numbers in parenthesis is the percentage of subjects who experienced these adverse events during or immediately after treatment.
  • All of these events were mild or moderate and resolved within 72 hours, except for the falls related to Parkinson’s disease. 
  • Complications that persisted at one year included: numbness/tingling (1.5%), dysarthria (1.5%), increased salivation (1.5%). The number in parenthesis is the percentage of active subjects experiencing these adverse events at the 12-month time point.
  • One serious pulmonary embolism was reported as procedure related due to several sedentary hours before and during the procedure, as well as airplane flights within 24 hours post procedure.
  • For additional safety information for Tremor Dominant Parkinson’s Disease, please refer to Pre-Market Approval P150038 Supplement S014. Again, you should discuss in detail the risks, benefits and treatment options with your physician prior to treatment.

CONTRAINDICATIONS (for all indications, with special considerations as listed below)

Focused ultrasound treatment with Exablate Neuro is contraindicated for use in:

  • Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, or allergies to MR contrast agent.
  • Patients who are pregnant.
  • Patients with advanced kidney disease or on dialysis.
  • Patients with unstable cardiac status or severe hypertension.
  • Patients exhibiting any behavior(s) consistent with ethanol or substance abuse.
  • Patients with history of abnormal bleeding, hemorrhage, and/or coagulopathy.
  • Patients receiving anticoagulant or drugs known to increase risk of hemorrhage within one month of focused ultrasound procedure.
  • Patients with cerebrovascular disease.
  • Patients with brain tumors.
  • Patients who are not able or unwilling to tolerate the required prolonged stationary position during treatment. The average treatment time (the time from the first scan to allocate transducer position and ending with the last energy delivery) is 1:56 ± 0.41 hrs (Min: 0.48 hrs, Max: 5:54 hrs).
  • Patients who have an Overall Skull Density Ratio of 0.45 (±0.05) or less as calculated from the screening CT.

Additional contraindication for Parkinson’s Disease, in addition to the above

  • Parkinson’s disease patients with unstable psychiatric disease, uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation.

Additional contraindication for Second Side Treatment in Essential Tremor, in addition to the above

  • Patients with clinically significant dysphagia, abnormal speech function, or gait abnormalities that are moderate to severe following the index Exablate unilateral thalamotomy procedure.

WARNINGS

  • 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.
  • Prolonged immobilization may lead to increased risk of deep venous thrombosis (DVT) or pulmonary embolism (PE). In order to avoid this, the patient should be wearing Thromboembolic Stockings (TEDs), also referred to as “anti-embolism” stockings through the entire procedure time in the MRI.

PRECAUTIONS

  • 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 treating physician 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.

    

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