New device approved by the FDA for the treatment of essential tremor
Release date: 2016-07-18
The US Food and Drug Administration recently approved the first focused ultrasound device for the treatment of patients with essential tremor that are unresponsive to medication.
“Patients with idiopathic tremors that have not improved their medications now have a new treatment option that can help them avoid more invasive surgery,†said Carlos Pea of ​​the FDA Center for Medical Devices and Radiation Hygiene, “with other idiopathic Like tremor therapy, this new device does not cure the disease but can help patients enjoy a higher quality of life."
Idiopathic tremor, also known as benign essential tremor, is the most common form of tremor. According to the National Institute of Neurological Disorders and Stroke, millions of people in the United States are affected by the disease, usually over 40 years of age. We may use beta blockers or anticonvulsants to treat essential tremors. In cases where the drug does not control the symptoms of the disease, surgery (thalamic incision) may be performed or a deep brain stimulation device may be used to destroy a small portion of the brain (thalamic) to control some unconscious movements.
To determine if ExAblate Neuro treatment is appropriate, patients must first undergo MR and computed tomography (CT) scans. Patients undergoing MRI-guided device therapy rely on MRI scans to obtain images to help the physician determine the target area of ​​the thalamus that needs treatment. The patient is always awake and responsive throughout the course of treatment.
Data supporting the safety and efficacy of the device system included a double-blind controlled trial involving 76 patients with essential tremor who did not respond to medication. Fifty-six patients were randomized to receive ExAblate Neuro and 20 received sham treatment. Patients in the control group can cross the treatment group after three months.
Compared with baseline scores, tremor and motor function (tremor/motor comprehensive score) in patients treated with ExAblate Neuro showed nearly 50% improvement in the three months after treatment. The patients in the control group did not improve, and some patients even had a slight deterioration after receiving the sham treatment (before the treatment group). At 12 months after treatment, these scores in the treatment group retained a 40% improvement from baseline.
Adverse events in ExAblate Neuro are consistent with reports of thalamic incision, including finger numbness/tingling, headache, imbalance/unstable, uncontrolled body movement (ataxia) or gait abnormalities. Other side effects that may be associated with MR-guided focused ultrasound therapy include tissue damage other than the treatment area, treatment area bleeding (emergency treatment required), skin burns and skin ulcers, skin contraction and scarring, and thrombosis.
Patients who cannot receive MR imaging cannot be treated with ExAblate Neuro, including those with MRI-incompatible metal implants (such as pacemakers), those who are allergic to MR contrast, or those who are unsuitable for MR examination .
This treatment also does not apply to pregnant women, patients with end stage renal disease or dialysis, patients with unstable heart disease or severe hypertension, patients who exhibit any behavior consistent with alcohol or substance abuse, or with abnormal bleeding, bleeding and/or coagulopathy A patient with a history of (coagulopathy). Patients who are currently taking anticoagulants or drugs known to increase the risk of bleeding, patients with a history of cerebrovascular disease (stroke) or brain tumors, and patients who cannot tolerate long-term quiescence during treatment should not receive this treatment.
Original search
FDA Approves First MRI-guided Focused Ultrasound Device to Treat Essential Tremor. Practiceupdate. July 11, 2016
Source: Medical Pulse
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