FDA approves first stroke rehabilitation system
SPRING SILVER, Md., August 27, 2021 / PRNewswire-HISPANIC PR WIRE / – The United States Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS (Vivistim System), a drug-free rehabilitation system, the first of its kind, to treat moderate to severe upper limbs. Motor deficits associated with chronic ischemic stroke – a stroke caused by blockage of blood flow to the brain with long lasting symptoms – using vagus nerve stimulation (VNS).
“People who have lost mobility in their hands and arms due to ischemic stroke are often limited in their treatment options to regain motor function,” said Christophe M. Loftus, MD, Acting Director of the Center for Devices at the FDA and the Bureau of Neurological Medicine and Physical Radiation Health Devices. “Today’s approval of the Vivistim Paired VNS System offers the first option in stroke rehabilitation using vagus nerve stimulation. Used in conjunction with rehabilitation exercise, this device may provide benefits to those who have lost upper limb function due to ischemic stroke. “
A stroke occurs when blood flow to part of the brain is interrupted, causing brain cells to die from lack of oxygen and nutrients in the blood. There are different types of stroke, but the most common type is ischemic stroke, which means that the blood vessels to the brain become blocked, preventing blood flow from reaching the brain. Depending on how long the brain is deprived of blood and where in the brain the stroke occurs, stroke can lead to brain damage, temporary or permanent disability and, in some cases, death. Disabilities resulting from stroke can include, but are not limited to, total or partial paralysis or difficulty in muscle movement.
The Vivistim System is intended for use, along with stroke rehabilitation therapy, in patients with ischemic stroke, to electrically stimulate the vagus nerve, a nerve that runs from the brain to the abdomen, to reduce impairments. of the upper limb. and motor function of the extremities and improve the ability of patients to move their arms and hands. To use the Vivistim system, an implantable pulse generator (IPG) – which generates a slight electrical pulse – is implanted just under the skin in the patient’s chest. Attached to the IPG is a conductive wire that is implanted under the skin and leads to electrodes that are placed on the left side of the neck where the vagus nerve is located.
The implantable components come with preloaded clinician software on a laptop computer and a wireless transmitter for use only by a healthcare provider. The software allows a healthcare provider managing a patient’s rehabilitation to enter the appropriate parameters on the IPG, including amplitude, frequency, and pulse width for pacing, and also records the history of stimulation, movements performed and information on IPG. The wireless transmitter communicates the adjustments to the IPG parameters made using the software.
The Vivistim System, a prescription device, can be used in both clinical settings and at home to deliver VNS. If it is to be used during home rehabilitation exercises, the software and wireless transmitter are not used by the patient. However, the patient is given a magnet which can be passed over the IPG implantation site to activate the IPG and begin a 30 minute stimulation session during the rehabilitation exercise. When directed by a physician and with proper programming of the IPG, patients are trained in the use of the Vivistim system at home, as well as its safety features, to avoid unwanted electrical stimulation.
The FDA evaluated the safety and efficacy of the Vivistim System in a clinical study involving 108 patients at 19 clinical sites in the US and UK who received the Vivistim System. The patients were divided into a study group (53 patients) and a control group (55 patients), in which the two groups were asked to perform 300 to 400 physiotherapy exercises for 90 minutes per day, three times per week. for six weeks. The control group received only a very low level of VNS for the first five exercises of the 300-400 movement series and had no stimulation for the remainder of each session. The treatment group received the appropriate amount of VNS throughout all 90-minute rehabilitation sessions. The two groups received physiotherapy sessions equivalent in quantity and quality. After the initial six-week study, all patients received follow-up assessments at 1, 30, and 90 days after the study.
The effectiveness of the Vivistim system was measured using the Fugl-Meyer Upper Limb Assessment (FMA-EU), a measure of stroke-specific motor impairment. Progress was measured as an increase in motor function from baseline after six weeks of treatment. Patients in the treatment group had an average score increase of 5 points, while patients in the control group had an average score increase of 2.4 points. In addition, 47.2% of people in the treatment group saw an improvement of 6 points or more in the FMA-EU score 90 days after treatment, compared to 23.6% in the control group.
Adverse events included, but were not limited to, dysphonia (difficulty speaking), bruising, falls, general hoarseness, general pain, hoarseness after surgery, moodiness, muscle pain , fractures, headaches, rashes, dizziness, throat irritation, urinary tract infections, and fatigue. .
The Vivistim System is not approved for use other than its intended use for stimulating the vagus nerve during chronic ischemic stroke rehabilitation therapy for moderate to severe loss of upper limb function. It should not be used in patients with a vagotomy, which is the surgical removal of part of the vagus nerve.
Patients should discuss any medical history with their providers: other concomitant forms of brain stimulation; current diathermy therapy, which uses electrical current stimulation to produce a “deep warm-up” under the skin in deep subcutaneous tissues, muscles and joints; depression or suicidality; schizophrenia, schizoaffective disorder or delusional disorder; rapid cycling bipolar disorder; previous brain surgery or central nervous system injury; progressive neurological diseases other than stroke; heart abnormalities, including arrhythmia; dysautonomias, or medical conditions caused by problems with the autonomic nervous system; respiratory illnesses or disorders, including dyspnea and asthma; ulcers; vasovagal syncope; and pre-existing hoarseness.
The Vivistim system has been granted Designation of the revolutionary device. To qualify for such designation, 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 state-of-the-art technology; there must be no approved or authorized alternative; the device must offer significant advantages over existing approved or authorized alternatives; or the availability of the device is in the best interest of the patients.
The FDA has reviewed the Vivistim Paired VNS MicroTransponder System under the Pre-market approval path (PMA). PMA is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective. for its intended use.
The Vivistim MicroTransponder Paired VNS System is manufactured by MicroTransponder Inc.
Media contact: Abby capobianco, 240-461-9059
Consumer inquiries: [email protected], 888-INFO-FDA
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
SOURCE US Food and Drug Administration