Neurostimulation is expanding into new therapeutic areas

A user-friendly neurostimulation device for stroke is awarded the CTI Swiss Medtech Award 2016. FDA approved Axium Neurostimulator System, the first of its kind, is a specifically designed dorsal root ganglion (DRG) stimulation device. Neurostimulation is showing presence in new therapeutic areas.

Neurostimulation devices are implantable devices that deliver mild electrical signals to specific neural circuits for a defined output. Neurostimulation devices are proven to be effective and flexible when drugs and surgery are inefficient. They are safe to use with reversible mechanism and manageable side effects. A wide range of products available today, including devices such as Fisher Wallace Simulator for treating depression in athletes. Neurostimulation devices have surmounted many hurdles, beginning from investigation of mechanism to designing of neuroprosthesis.

For the past four decades, neurostimulation devices have been used to treat conditions such as Parkinson’s disease, chronic pain ranging from neuropathic pain to severe headaches, epilepsy and others. These devices are catered by companies such as LivaNova, Boston Scientific, EnteroMedics Inc, NeuroPace Inc. Minimal invasive, miniaturization, compact power supplies, and neuroscience have fueled growth of modern applications of neurostimulation devices. Medtronic developed tined lead in 2002, making the procedure minimally invasive. Later in 2006 Medtronic improved the technology with a smaller neurostimulator and improved patient programmer. Most of the devices are accompanied by programmer for better and planned control.

According to GlobalData estimates, Spinal Cord Stimulators and Deep Brain Stimulators are a major contributor to the neurostimulation market. They constituted a global market value of around $2.71bn in 2016. LivaNova, a sole company producing implantable Vagus nerve stimulator, reported 351.4 million USD in 2016 for neurostimulation devices. This is around 8.8% growth as compared to 2015.

Increasing aging population, unmet medical needs, eminent reimbursement policies and insurance approvals are strengthening the market with plethora of devices. Though the market is witnessing growth, there are a few hindrances such as ambiguous mechanism of action and side effects. Complexities in designing a neurostimulation device, limited patient pool and clinician’s bias towards opting for the device, and lack of experts are discouraging the innovation in unexplored therapeutic areas. Lack of funding and association has made the march forward less notable in new therapeutic areas, compared to progress in other therapeutic areas. Lack of comparative and long term studies is restricting the way towards peak.

The correct usage of device in empirical treatment is very important. Neurostimulation today is confined to last line of therapy or alternative treatment for resistant patients. Neurostimulation devices operate on the principle of open-loop, which is unidirectional signal from device to brain, or closed-loop, which is bidirectional signal, moves in both sensing and responding directions and can be the next frontier for this device hunt. More sophistication is required for optimization of patient pool, prosthesis design, placement and stimulation parameters.

The future appears bright with new indications, in line for approval, such as DBS for Alzheimer’s, anxiety, sleep disorder, electronic aspirin for migraine, Vagus nerve stimulator for heart failure and many more. Advancements in medical science may gift us with engineered neurostimulation devices of first-line therapy with minimal side effects and a replacement to the drug fog.