FDA APPROVES THE FIRST REHABILITATION SYSTEM FOR ISCHEMIC STROKE

Edited by, JASPER VICTORIA

A stroke is a condition which occurs when a part of the brain suffers of interruption, obstruction or reduction in blood flow, which  makes the neural tissues deficient of oxygen and essential nutrients, due to which the neural tissues might die.

It is a medical emergency which needs immediate hospitalization to prevent death or further complications.

Ischemic stroke is a type of stroke also called as cerebral ischemia in which the blood flow to brain is blocked as a consequence of clogging of the blood vessels of the brain which obstructs the flow of blood to the brain. The duration and severity of the stroke determines its complications, whether temporary or permanent, or even death. Difficulties in movements of muscles, partial or complete paralysis might also occur.

The Vivistim rehabilitation system is a prescription device intended to provide vagus nerve stimulation during the post-stroke rehabilitation therapy either at home or at hospital. It helps improving the motor functions of the upper limbs and extremities and enhance the movements of the hands and arms. The patients are implanted with an implantable pulse generator in the skin under the chest region. The implant consists of a lead wire which runs over the skin over the vagus nerve and is capable of generating a mild electric impulse.

It consists of a clinical software which can monitor and feed information regarding the amplitude, frequency and pulse and record information regarding the movements performed by the patient having the implant. 

The FDA approves the Vivistim system based on evaluation of safety in 108 patients and the effectiveness was measured by Upper Extremity Fulg-Meyer Assessment. The motor function was found to increase after 6 weeks of Vivistim therapy.

It is contraindicated in patients who had undergone a vagotomy. Breakthrough device designation was granted to the Vivistim implant of the MicroTransponder Inc. 

The  adverse events observed during the evaluation of safety were dysphonia, falls, bruises, muscle pain, dizziness, changes in mood, UTI, fatigue, throat irritation and fractures.