FDA approves the first stroke rehabilitation device-Vivistim for vagus nerve stimulation

Stroke occurs every hour and every minute in China.
Once it occurs, if it is not treated in time, the patient will become disabled in the slightest, and death in the severe case
.

Whether a stroke causes disability or death, it will bring a heavy burden to the patient's family and society

Stroke

According to data from the "China Stroke Report 2019", at least 1 in every 5 deaths died of a stroke
.

The death toll from stroke in China accounts for about 1/3 of the global death toll from stroke, and there are as many as 13 million stroke patients living with the disease in China

Although early prevention can effectively prevent the occurrence of strokes, a large number of strokes still occur
.

Seven to eighty percent of the patients will have physical sequelae, and can only be accompanied by crutches and wheelchairs in the second half of their lives

prevention

For these patients, how to get them to recover from a stroke is a very real problem
.

However, the existing rehabilitation methods have been unable to meet the needs (the patient cannot completely recover from the disability of stroke), and new technologies are needed to meet the unmet needs

The FDA recently approved a new treatment method for stroke rehabilitation-Vivistim
.

Vivistim is a Vagus Nerve Stimulation (VNS) device that is used to restore motor function to people who have lost hand and arm mobility due to ischemic stroke

FDA

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Vivistim

Vivistim is a prescription medical device that can be used in clinics and homes
.

If it is to be used during home rehabilitation exercise, the patient does not use VNS APP and VNS wireless generator

 Vivistim consists of four parts:

• VNS implantable pulse generator

VNS implantable pulse generator

VNS implantable pulse generator

• VNS electrode wire

VNS electrode wire

VNS electrode wire

• VNS APP and VNS wireless generator

VNS APP and VNS wireless generator

VNS APP and VNS wireless generator

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Vagus nerve stimulation therapy (VNS)

The vagus nerve is different from any other nerve in the body
.

It is directly connected to the brain and sends important signals to tell the brain what to learn

Vivistim also uses this natural response system to directly stimulate the vagus nerve when the patient moves the muscles, which tells the brain to "pay attention" to muscle movement
.

The simultaneous pairing of this muscle movement with vagus nerve stimulation (VNS) strengthens the motor neuron circuit responsible for this movement

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Vivistim clinical data

The FDA has enrolled 108 stroke patients in 19 centers in the United States and the United Kingdom to evaluate the safety and effectiveness of Vivistim
.
The patients were divided into a test group (53 patients) and a control group (55 patients).
Both groups were required to complete a 90-minute rehabilitation treatment every day, including 300-400 exercise exercises
.
The control group received only very low levels of VNS in the first 5 exercises of 300-400 exercises, and there was no stimulation in the rest
.
The treatment group received an appropriate amount of VNS during the 90-minute rehabilitation course
.
Both groups received rehabilitation treatments of comparable quantity and quality
.
After receiving 6 weeks of treatment, all patients underwent follow-up evaluation at 1, 30 and 90 days after the end of treatment
.

Using upper limb Fugl-Meyer score (FMA-UE, upper limb motor function assessment scale), after 6 weeks of treatment, compared with baseline, the average score of patients in the experimental group increased by 5 points, while the average score of patients in the control group increased by 2.
4 points
.
In addition, 90 days after treatment, 47.
2% of patients in the experimental group improved their FMA-UE score by ≥6 points, compared with 23.
6% in the control group
.

Although Vivistim is more effective than traditional rehabilitation methods, there are still some adverse events
.
Examples include dysphonia (difficulty speaking), bruises, falls, hoarseness, general aches, postoperative hoarseness, depression, muscle pain, fractures, headaches, rashes, dizziness, throat irritation, urinary tract infections, and fatigue
.

Infect

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Vivistim demo

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MicroTransponder

MicroTransponder has developed a paired vagus nerve stimulation system based on decades of neuroscience research
.
Paired VNS is designed to treat a variety of neurological diseases
.
Our initial focus is on upper limb defects in chronic stroke patients
.
Vivistim enables stroke survivors to restore upper limb mobility
.

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