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On August 27, 2021, the US FDA approved the Vivistim Paired VNS System (Vivistim System) rehabilitation system developed by MicroTransponder to treat stroke patients
.
This is a non-drug-based rehabilitation system designed to use electrical vagus nerve stimulation (VNS) to treat moderate/severe upper extremity motor deficits associated with chronic ischemic stroke
When the blood flow to part of the brain is interrupted, a stroke occurs, causing brain cells to die due to lack of oxygen and nutrients in the blood
.
There are different types of stroke, but the most common type is ischemic stroke, where the blood vessels leading to the brain become blocked, thereby blocking blood flow to the brain
The Vivistim system is a prescription medical device that can be used in clinics and homes
.
The Vivistim system is expected to be used together with post-stroke rehabilitation therapy to treat patients with ischemic stroke, by electrically stimulating the vagus nerve, reducing motor deficits in the upper limbs and limbs, and improving the patient's ability to move arms and hands
Image source: MicroTransponder's official website
Previously, the FDA evaluated the safety and effectiveness of the Vivistim system in a clinical study of 108 patients
.
The patients were divided into a test group (53 cases) and a control group (55 cases).
Using the upper limb Fugl-Meyer score (FMA-UE, an indicator for detecting stroke-specific dyskinesias), after 6 weeks of treatment, compared to baseline, the average score of patients in the Vivistim system treatment group increased by 5 points, while the average score of patients in the control group The score has increased by 2.
4 points
.
In addition, 90 days after treatment, 47.
In terms of safety, adverse events include but are not limited to dysphonia (difficulty in speaking), bruising, falls, hoarseness, whole body pain, postoperative hoarseness, depression, muscle pain, fractures, headache, rash, dizziness, throat irritation, urine Road infection and fatigue
Reference materials:
[1] FDA Approves First-of-Its-Kind Stroke Rehabilitation System.
