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First FDA-Approved Nerve Stimulation Device For Stroke Recovery

Vivistim is a prescribed medication for strokes individuals who are having trouble using their hands and arms, but the severity of their condition ranges from moderate – to – severe. Electrical current stimulating the nervous system, which begins in the brain and extends to the stomach, is possible at home or a hospital.

The U.S. Food and Drug Agency has approved the first-of-its-kind method of neuromodulation for patients with stroke who are unable to use their hands.

First FDA-Approved Nerve Stimulation Device For Stroke Recovery

Dr. Christopher Loftus described: “People who have suffered ischemic strokes and have lost mobility in their hands and arms are limited in the therapy options they have for restoring motor function.” He is in charge of the Center for Devices and Radiological Health’s Office of Neurological and Physical Medicine Devices, which is located in the FDA (Food and Drug Agency). A clot in the brain’s blood vessels causes an ischemic stroke.

First FDA-Approved Nerve Stimulation Device For Stroke Recovery

Here it is noteworthy that stroke is one of the main causes of death among people above 40 which has been deciphered by experts with the help of several types of research. This device can help the nerves stimulate in a way that can keep the evil effects of a stroke at bay and save the life of the concerned patient. After proper analysis and frequent sampling, the research was placed in front of the authorities and now it has got an official form with approval from the FDA. The device can be officially used now. 

A clinical study of 108 patients with stroke in the United States and the United Kingdom provided the basis for the FDA’s approval of the system. For 6 weeks, the therapeutic group got the correct amount of vagus nerve stimulation (VNS), while the control arm merely got 300 to 400 physical therapy activities for 90 minutes per day, 3 times a week. A comparison group that got only minimal stimulus participated.

“Today’s approval of the Vivistim Paired VNS System offers the first stroke rehabilitation option using Vagus Nerve Stimulation [VNS],” Loftus said in an FDA (Food and Drug Agency) news release. “Used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke.”

A battery-powered device is implanted just beneath the flesh of the client’s chest, delivering a modest jolt of electricity. The FDA also noted that a wire was put beneath the skin and that impulses were sent to electrodes in the neck area, on the bottom left, where the nerve is found.

In addition to computer programs and a Bluetooth emitter, the system also offers a variety of portable devices.

The study’s results showed that individuals who were given treatment with the device and given additional physical therapy for three months were able to recover the use of their hands and arms more effectively than those in the comparison category.

The new device was approved under the FDA’s Breakthrough Device designation. To qualify, “a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives, or the availability of the device is in the best interest of patients,” the Food and Drug Agency said.

A list of potential effects produced by the Vivistim Systems can be found on the FDA website, which includes problems with speech, bruises, falling, difficulty breathing, discomfort, poor mood, fractures, migraine, rash, vertigo, sore throats, bacterial infection, and exhaustion.

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