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This device, a pad called Relaxis, was approved on Friday. The patient lies on the bed and puts his feet on the pads. This will gradually reduce the vibration and stop.Approval is based on two studies showing that the device is superior to placebo pads for improvement sleep In the patient RLS, Sensory Medical Inc. said in a statement.
This device is an alternative for patients who are being treated by standing up and moving their legs to relieve symptoms (this is interrupted) sleep) Or anticonvulsants, opioids, muscle relaxants, or sleep Medicine, the company says.
The company’s website states that Pads may make RLS Symptoms worsen and improve within 3 weeks of discontinuing use of the device. Other side effects include leg cramps, pain, pain, And Motion sickness..
The new device will be available prescription-only in the United States later this year, the company said.
Source: Medscape: “The FDA has approved the first device for restless legs syndrome.”
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FDA Approves First Device for Restless Legs Syndrome
Source link FDA Approves First Device for Restless Legs Syndrome