Home Healthcare Frequent Approval and Launch of Novel Vagus Nerve Stimulators
Frequent Approval and Launch of Novel Vagus Nerve Stimulators

Frequent Approval and Launch of Novel Vagus Nerve Stimulators

In July 2017, electroCore, Inc. launched gammaCore (non-invasive vagus nerve stimulator) for acute treatment of pain associated with episodic cluster headache in adult patients in the U.S. gammaCore is a non-invasive, hand-held medical device applied at the neck and sends gentle, patented electrical stimulation through the skin to activate the vagus nerve, resulting in the reduction of pain.

In June 2017, LivaNova Plc. received the U.S. FDA approval for its VNS therapy system for treatment of patients as young as four years of age with partial onset seizures that are refractory to antiepileptic medications.

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High prevalence of depression epilepsy and migraine in key regions is expected to drastically rise demand for vagus nerve stimulators for its treatment. For instance, according to the data published by the Centers for Disease Control and Prevention in 2015, around 3 million U.S. adults and 470,000 children had active epilepsy (under treatment or with recent seizures). The number of adults with active epilepsy increased from 2.3 million in 2010 to 3 million in 2015.

According to the data published by National Institute of Mental Health in 2016, an estimated 16.2 million adults in the U.S. had at least one major depressive episode. This number represented 6.7% of all U.S. adults. According to the same source the prevalence of major depressive episode was higher among adult females (8.5%) compared to males (4.8%) and the prevalence of adults with a major depressive episode was highest among individuals aged 18-25 (10.9%).

Approval and launch of novel products in market is also expected to support the vagus nerve stimulators market growth over the forecast period. For instance, in June 2017, electroCore, Inc. received the U.S. Food and Drug Administration (FDA) 510(k) clearance to market a newer version of gammaCore (non-invasive vagus nerve stimulator) – the gammaCore-S – for acute treatment of pain associated with episodic cluster headache (eCH) in adult patients.

Furthermore, in February 2019, the U.S. Centers for Medicare & Medicaid Services (CMS) finalized its national coverage determination (NCD) for the LivaNova Plc.’s vagus nerve stimulation therapy (VNS Therapy) System for treatment-resistant depression (TRD). Such favorable reimbursements for VNS devices for depression treatment is also expected to increase its adoption and drive vagus nerve stimulators market growth.

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Vagus nerve stimulators are widely used in the management and treatment of diseases such as epilepsy, depression, and migraine. High prevalence of such diseases in key regions is expected to drive vagus nerve stimulators market growth over the forecast period. For instance, according to the data published by the National Institute of Mental Health, depression was one of the most common mental disorders in the U.S. in 2016. An estimated 16.2 million adults in the U.S. had at least one major depressive episode. This number represented 6.7% of all the U.S. adults.

Vagus nerve stimulators received approval from regulatory authorities for treatment of various disorders such as depression, migraine, and epilepsy. However, there are lot of alternative treatment options such as pharmaceutical drugs, antiepileptic medications, antidepressants, anticonvulsants, and others. Moreover, majority of these drugs have lost patent protection and cheaper generic versions have been made available in the market by leading generic manufacturers. Physicians as well as patients are more likely to give preference to cheaper drugs rather than medical devices. Hence, presence of cost-effective alternative treatment options for the treatment of these diseases is expected to be major factor hampering the adoption of vagus nerve stimulator devices and in turn, is expected to hinder the vagus nerve stimulator market growth over the forecast period.

Key players operating in the vagus nerve stimulators market include electroCore, Inc., LivaNova, PLC, SetPoint Medical Corporation, MicroTransponder, Inc., Beijing PINS Medical Co., Ltd., Parasym Ltd., Nervana, LLC, and tVNS Technologies GmbH.

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