The device received Food and Drug Administration premarket approval Aug. 5. Here are seven takeaways.
1. The device allows surgeons to use an ultrasound to converge on a specific point in the brain, heating it up and burning away the problem brain tissue.
2. As many as 10 million people in the U.S. suffer from essential tremor which manifests itself in involuntary movements characterized by shaking in the hands.
3. When patients don’t respond to drug therapy, surgery is the next option for addressing the tremors. The two options that currently exist require breaking the skin and either implanting a neurostimulator to deliver electrical signals to certain areas of the brain or destroying a part of the thalamus to stem the tremors.
4. The ultrasound technology is less-invasive, but still challenging. When using the tech that InSightec designed the patient is fully conscious for the surgery, but instead wears a cooling cap to not overheat during the surgery.
5. InSightec studied its technology for three years as in a randomized and sham-controlled clinical trial involving 76 patients who did not respond to drug therapy. According to trial results, patients treated with focused ultrasound showed a nearly 50 percent improvement in their tremors and motor function compared to their baseline score.
6. After one year the treated patients retained a 40 percent improvement over the baseline scores. The control group showed no improvement.
7. The FDA requires InSightec to conduct follow up studies evaluation the patients from clinical trial through five years to gather long-term information about the device.
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