The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands, but can also affect other parts of the body. The ExAblate Neuro usesmagnetic resonance imaging (MRI) to guide a focused ultrasound beam to destroy a small part of the thalamus, a section of the brain thought to control some involuntary movements. According to INSIGHTEC’s website, the “revolutionary non-invasive treatment offers a life changing treatment to patients with essential tremor, tremor dominant Parkinson’s Disease and neuropathic pain.”
According to the FDA press release, the procedure works as follows:
To determine if the ExAblate Neuro treatment is appropriate, patients should first have MR and computerized tomography (CT) scans. Those undergoing treatment with the MRI-guided device lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus for treatment. Treatment with transcranial focused ultrasound energy is administered with incremental increases in energy until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.
As noted in the press release, the FDA relied on a recently-presented study of the device’s effectiveness. 76 patients exhibiting symptoms of essential tremor participated in the study. 56 patients received the ExAblate Neuro treatment, whereas 20 patients received a placebo treatment. Patients receiving INSIGHTEC’s ExAblate Neuro treatment showed a nearly 50% improvement after three months. However, Patients who received the placebo treatment exhibited no improvement, and some experienced a slight worsening in symptoms. Patients receiving the placebo treatment were able to “cross over” and join the treatment group after three months had elapsed. All patients (including the “cross over” patients) who received the ExAblate Neuro treatment retained about 40% improvement after twelve months. The study’s findings were presented at the 20th International Congress of Parkinson’s Disease and Movement Disorders.
Unfortunately, patients who cannot undergo an MRI, such as those with implantable metallic devices, are ineligible for the treatment.
Please watch video:
http://www.jdsupra.com/legalnews/fda-approves-first-mri-guided-81695/
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