Increasing Acceptance of Neuromodulation Devices for Pain Management, Central Nervous System, and Urology Disorders

Neuromodulation is the alteration or modulation of nerve activity by delivering electrical or magnetic field directly to a target area for the treatment of various conditions such as pain management, central nervous system disorders, gastroenterology and urology, and other disorders. Neuromodulation treatment is considered when all other conventional methods fail to improve the condition of the patient. Some of the common nerve targets used for stimulations are sacral nerve, peripheral nerve, vagus nerve, phrenic nerve, posterior tibial nerve, cranial nerve, hypoglossal nerve, and others.

In market there are many conventional methods like pharmaceutical drugs, surgeries, and medical devices used to treat Parkinson’s diseases, chronic pain, urinary and fecal incontinence. But these methods may cause side effects or it may not be an effective treatment option. To full-fill the unmet need in the market Neurostimulation has become an emerging treatment option for chronic pain, Parkinson’s diseases, urinary and fecal incontinence, epilepsy and others diseases and its primary goal is to achieve treatment efficacy that cannot be obtained by any other medication or surgery. According to the North American Neuromodulation Society (NANS) and American Society of Interventional Pain Physicians (ASIPP), the most effective alternative therapy for chronic pain, central nervous system disorders, and urology are spinal cord stimulation (SCS), deep brain stimulation (DBS), vagus nerve stimulation (VNS), sacral nerve stimulation (SNS), peripheral nerve stimulation (PNS), transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES) and others.

Reimbursement plays an important role as the neuromodulation products are highly expensive and low reimbursement rates may hinder the usage of products. In the U.S. the Centers for Medicare and Medicaid services provide the reimbursement for all the major surgeries. There are many other private and government initiative centers that provide reimbursement facilities. Across geographies, the reimbursement scenario varies for neuromodulation treatment, in North American countries such as the U.S. and Canada, favourable reimbursement policies are enabling adaption of the technology. In Europe also a favourable reimbursement policy can be seen for neuromodulation devices technologies that have got necessary regulatory approval.

One of the main advantages of neuromodulation is the administration of therapy can be withdrawn if there are any adverse indications and also, cost of development of therapy is substantially low when compared to drug development so there is much demand for the Neuromodulation therapies. The neuromodulation technology utilizing stimulation of the spinal cord has emerged as one of the promising treatments for the management of pain. For instance, Saluda Medical (Australia) has developed Evoke ECAP controlled closed-loop spinal cord stimulation (SCS) system for patients suffering from chronic pain which received CE mark approval in September 2019. It is a first closed-loop SCS system that measure’s the spinal cords response to stimulation and adjusts on every pulse. As there is a favorable reimbursement for neuromodulation products and treatments can be withdrawn if there is any adverse indication, which is drawing more number of patients to accept neuromodulation device treatment.

In 2019, a total of 7 CNS drugs were approved by the FDA, there is a decrease of 22.2% compared to drugs approved in 2018. The decrease in the number of CNS drugs approvals is due to the high stringent regulations, side effects and abuse of some CNS drugs like opioids. To fill this void in lack of proper therapeutic agents, Neuromodulation devices today crosses therapeutic indications by targeting central nerve activity to treat diseases like Parkinson’s, Alzheimer’s, depression and epilepsy, as well as peripheral pain, urinary and fecal incontinence. DBS has emerged as an effective therapy for the management of Parkinson’s disease, epilepsy, dystonia, essential tremor, and depression. For instance, in January 2019, Boston Scientific Corporation has launched the Vercise Primary Cell (PC) and Vercise Gevia Deep Brain Stimulation (DBS) systems featuring the Vercise Cartesia Directional Lead. These systems are designed to allow physicians to control the range, shape, position, and direction of electrical stimulation to treat the symptoms of Parkinson’s disease (PD) through highly personalized therapy. LivaNova Plc makes the VNS therapy system comprised of the SenTiva generator and next-generation programming system, marketed for patients with drug-resistance epilepsy and treatment-resistant depression. The device is also being studied to treat obstructive sleep apnea and heart failure patients.

In the market there many medications and devices are available to treat urinary and fecal incontinence. But these medications are not effective as compared to neuromodulation devices and this is a reversible treatment option that can be discontinued at any time by turning off or removing the device. Due to these advantages, physicians and patients are preferring neuromodulation devices over other treatment options. To tap this growing market many players are focusing on product development, launch and approval of the neuromodulation devices to treat urinary and fecal incontinence. For instance, Axonics Modulation Technologies, Inc. is marketing a novel implantable rechargeable sacral neuromodulation (r-SNM) device for the treatment of urinary and bowel dysfunction received USFDA approval in September 2019. r-SNM system offers a long-lived miniaturized neurostimulator that is approximately the size of a USB stick and is qualified to last 15 years in the body.

Patients with implanted neuromodulation device may not be compatible with an electromagnetic device such as MRI, as electromagnetic field generated by an MRI may damage the device and induce voltage through the lead could shock the patient. To overcome this some of the companies have developed neuromodulation devices that are electromagnetic compatible (EMC). For instance, Proclaim DRG system, Proclaim Elite recharge free SCS system – Abbott Laboratories, StimQ PNS – Stimwave LLC and Precision Montage MRI SCS system, Precision Novi Primary cell SCS system – Boston Scientific Corporation.

The top players in the Neuromodulation Devices global market are Medtronic Plc (Ireland), Abbott Laboratories (U.S.), Boston Scientific Corporation (U.S.), LivaNova Plc (U.K.), Nevro Corporation (U.S.), Inspire Medical Technologies (U.S.), Nuvectra (U.S.), Neuropace Inc. (U.S.), Bioness Inc. (U.S.), Beijing PINS Medical Co., Ltd. (China), Neuronetic (U.S.) and Laborie Medical Technologies, Inc. (Canada).

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