Abbott Receives FDA Approval for Eterna™, the World’s Smallest Rechargeable Spinal Cord Stimulator for Chronic Pain

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On December 19 local time, Abbott announced that its Eterna™ Spinal Cord Stimulation (SCS) system has received approval from the U.S. Food and Drug Administration (FDA) for market release.It is reported that Eterna™ is currently the smallest implantable, rechargeable spinal cord stimulator on the market, used for treating chronic pain.

In addition, Eterna SCS utilizes Abbott's proprietary low-dose BurstDR™ stimulation technology, the only SCS waveform technology with the highest level of clinical evidence, which has been proven to reduce pain by 23% more than traditional waveform techniques. This neuromodulation device offers an optimized experience.Only five wireless charges per year, with the lowest charging burden compared to other rechargeable SCS systems.

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World's Smallest Rechargeable Spinal Cord Stimulation System

Spinal Cord Stimulation (SCS) technology, initially inspired by cardiac pacemakers, has been recommended by doctors for over 50 years to help people manage chronic pain and improve their quality of life. It is one of the most advanced minimally invasive treatments in modern medicine for spinal cord injuries. The devices used in SCS include thin wires placed between the spinal cord and vertebrae and small implants positioned under the skin in the lower back, which interrupt pain signals from reaching the brain to relieve pain. This technology is widely applied in areas such as ischemic pain in the lower limbs and neuropathic pain caused by spinal cord injuries.

Due to the significant efficacy of spinal cord stimulation in treating pain, more than 100,000 patients worldwide now undergo spinal cord stimulator implantation each year.In the United States, more than 50 million people suffer from chronic pain. According to data from the American Pain Foundation, chronic pain is the leading reason people visit doctors, costing the nation approximately $635 billion annually in healthcare, disability, and lost productivity.

AbbottAbbott has developed the Eterna SCS (Spinal Cord Stimulation System), creating the Eterna, which requires fewer than five charges per year under normal use, making it the platform with the lowest charging burden on the market.The main functions include:

Minimum Equipment

Abbott has fully considered daily comfort in the design,Making the Eterna SCS System the smallest implantable, rechargeable spinal cord stimulator currently on the market.

Clinically Proven Therapy

Eterna SCS System Utilizes Abbott's Proprietary BurstDR Stimulation, Mimicking Natural Discharge Patterns Found in the Brain. Provides Superior Pain Relief.It is reported that 87% of patients prefer BurstDR stimulation over traditional "tingling" tonic stimulation.

Minimum charging burden

The Eterna SCS system, combined with Abbott's new Xtend™ energy technology, optimizes the patient's charging experience when using a standard wireless charger.Only needs to be charged five times a year.

Magnetic Resonance Imaging Function

Eterna Utilizes Abbott’s TotalScan™ MRI Technology, Which Allows for Whole-Body MRI Scans – An Urgent Need for Chronic Pain Patients Requiring Improved Diagnosis and Healthcare.

Upgradable Platform

With Abbott's continuous advancements in SCS therapy,The Eterna SCS system can adapt to future innovations without the need for implant replacement.

Apple Integration

Abbott's patient-centered mobile application supports real-time battery life and charging status updates for the Eterna SCS system on personal or Abbott-provided Apple devices.

Pedro Malha, Vice President of Abbott Neuromodulation, stated: "At Abbott, the products and solutions we provide are designed to simplify healthcare, improve clinical outcomes, and offer the best experience for patients with chronic pain. As we continue to advance in this commitment, Eterna represents the next major leap." "Eterna is the smallest rechargeable spinal cord stimulator on the market, offering the longest interval between charges for treatment and providing an optimized charging experience – all key features when choosing the best overall system."

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Abbott's Neuroregulation Product Layout

As a global leader in the healthcare industry, Abbott brings cutting-edge technology to life, with leading products spanning diagnostics, medical devices, nutrition, and pharmaceuticals.In 2016, Abbott acquired St. Jude Medical for approximately $25 billion (approximately RMB 160 billion). Through this acquisition, Abbott has since become a leader in the cardiovascular and neuromodulation fields.

Later, Abbott launched a mobile app in the field of neuromodulation to record patients' pain relief, aiming to improve the user experience for patients implanted with Proclaim XR and Proclaim DRG.

In March 2021, Abbott also launched a neuromodulation therapy platform approved by the FDA, which allows doctors to communicate with patients and monitor or adjust treatment plans in real time. According to Abbott, the NeuroSphere Virtual Clinic can improve treatment access for patients with chronic pain or movement disorders, either because they live far from healthcare providers or due to the COVID-19 situation, making it difficult for them to receive care or medical attention.

The Patient Controller app received FDA approval in July 2020. It is a product of the NeuroSphere Virtual Clinic, offering secure in-app video chat and integrated remote programming capabilities. Through this application, clinicians can remotely transmit new treatment prescriptions to a patient’s neurostimulation device and it is compatible with multiple neuromodulation products from Abbott.

Current neuromodulation product portfolio,In addition to the recently approved Eterna™ Spinal Cord Stimulation (SCS) System, there are also the Proclaim Plus Spinal Cord Stimulation (SCS) System with FlexBurst360™ technology (approved by the FDA in August this year), the Proclaim™ XR Recharge-Free SCS System, the Invisible Trial System, the Proclaim™ DRG System, and the ST. JUDE MEDICAL™ Infinity DBS System, among others.

Proclaim Plus SCS System

Proclaim Plus Spinal Cord Stimulation (SCS) System is built on Abbott's proprietary BurstDR stimulation therapy, which delivers pulses or bursts of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain. The FlexBurst360 therapy used can cover pain in up to six areas of the trunk and/or limbs and can be adjusted according to the evolution of individual treatment needs.And the system does not require charging, with a battery life of up to 10 years, and can be used with Abbott's NeuroSphere Virtual Clinic, allowing people to connect with their doctors and receive remote programming adjustments.

Proclaim™DRG System

Proclaim™ DRG System, for the treatment of neuropathic pain post-surgery/injury and Complex Regional Pain Syndrome (CRPS),Is the first neurostimulation device applicable to CRPS, with its Bluetooth wireless technology and iOS software offering patients an intuitive treatment experience.

ST. JUDEMEDICAL™ Infinity DBS System

ST. JUDEMEDICAL™ Infinity DBS System. The pulse generator communicates with the brain through leads, and iOS devices allow doctors to adjust settings for personalized treatment.

Among them, the Proclaim XR and Proclaim Plus products, like the newly approved Eterna system, also utilize Abbott's low-dose BurstDR stimulation technology. It is reported that BurstDR therapy is Abbott's proprietary stimulation technology, which provides gentle electrical pulses to alter pain signals as they travel from the spinal cord to the brain.

Clinical studies show that, compared with tonic stimulation, BurstDR technology can provide superior pain relief, improve people's daily lives, and reduce emotion-related pain associated with pain.Compared with standard tonic stimulation technology (which provides patients with a continuous stinging sensation), 87% of people prefer BurstDR technology, which relieves pain within a sub-perceptual range that patients cannot feel.

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Market Landscape

With the continuous intensification of global population aging, the number of patients with neurological diseases keeps growing. Neuromodulation is an emerging technology used to treat or alleviate neurological diseases. Its applications mainly include Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), Vagus Nerve Stimulation (VNS), etc. The treated diseases cover numerous fields such as nervous system injuries, motor dysfunction, chronic pain, spasticity, epilepsy, gastrointestinal and bladder dysfunction, peripheral vascular disease, cardiac ischemia, audiovisual disorders, and psychosomatic diseases (e.g., depression, obsessive-compulsive disorder, Tourette syndrome).

In the past few decades, hundreds of thousands of patients have benefited from neuromodulation, and new applications for this treatment technology are continually being discovered.According to relevant data statistics, in 2020, the global market size of neuromodulation reached 5.8 billion US dollars.

The United States is currently the largest global market for the production and consumption of implanted neurostimulators, accounting for approximately 40% of the global market share.Among them, the top three细分 markets are spinal cord stimulation (SCS), deep brain stimulation (DBS), and vagus nerve stimulation (VNS), accounting for 54.67%, 16.52%, and 14.19%, respectively. Currently, the global neuromodulation market is predominantly occupied by the three major giants: Medtronic, Abbott, and Boston Scientific.

In China, with the growth of the elderly population and the increase in the prevalence of chronic diseases, the market for neuromodulation products is also expanding. Data from the "Report on the Development of Pain Medicine in China (2020)" shows that the number of patients with chronic pain in China has exceeded 300 million and is growing at a rate of 10 to 20 million per year. However, due to the low level of awareness among some domestic patients regarding pain treatment, the market promotion of spinal cord stimulators still faces significant resistance.

With the increase in residents' disposable income and the deepening public awareness of pain treatment, the market space for spinal cord stimulators in China is expected to further expand. Notably, Guangdong, Yunnan, Beijing, and other regions have already included spinal cord stimulator products in the scope of medical insurance payments.In recent years, a number of domestically produced enterprises have emerged in the field of neuromodulation devices, such as SceneRay Medical and PINS Medical, etc., with huge market potential.The following is a brief introduction to the layout of some enterprises in the field of neuromodulation.

Medtronic

Medtronic's leading position can be attributed to its extensive portfolio of neuromodulation devices and strong geographic coverage.There are strong product and technical supports in the four fields of deep brain stimulation, spinal cord stimulation, sacral nerve stimulation, and targeted drug delivery systems (TDDS).

Deep Brain Stimulation:PERCEPT™ DBS Platform (BrainSense™ Technology), ACTIVA™ DBS Platform, etc.Among them, the PERCEPT™ DBS platform uses sensing technology to capture and record brain signals, adjusting according to patient needs to provide personalized, data-driven treatment.

Spinal Cord Stimulation:INTELLIS™ Platform (AdaptiveStim™ Technology, SureScan™ MRI Technology), PrimeAdvanced™ Neurostimulator, Restore™ Neurostimulator, etc. Among them,INTELLIS™ is currently the smallest neurostimulator in global spinal cord stimulation systems, weighing only 29.1 grams, with an implantation depth increased to 3cm.In May 2021, Intellis™ was approved for marketing in China.

Sacral Nerve Stimulation:INTERSTIMWITHOUT LIMITS™ System,The system provides digital health solutions by connecting evaluation systems and intelligent programs.

Targeted Drug Delivery System:SYNCHROMED™ II Targeted Drug Delivery System,Targeted drug delivery for chronic pain treatment, personalized therapy achieved through myPTM™ Personal Therapy Manager and Efficio™ Management Software.

Boston Scientific

Boston Scientific has made strategic investments in the fields of spinal cord stimulation and deep brain stimulation, while also developing two key products in minimally invasive solutions: the Indirect Decompression System (IDS) and Radiofrequency Ablation (RFA).Form a multi-dimensional neuromodulation product portfolio.

Spinal Cord Stimulation:SpectraWaveWriter™ SCS System, a device with multiple spinal cord stimulation therapies,Can provide personalized, long-lasting pain relief.

Deep Brain Stimulation:VerciseGevia™ DBS System, which uses directional leads to control Parkinson's symptoms through highly personalized therapy.Doctors can adjust the range, shape, position, and direction of electrical stimulation to reduce adverse side effects and provide continuous relief of Parkinson's symptoms as the condition progresses.

Indirect Decompression System:Vertiflex® Procedure (Superion® IDS System), a clinically proven minimally invasive solution designed to provide long-term relief from pain associated with lumbar spinal stenosis (LSS).

Radiofrequency Ablation System:RFA system is a minimally invasive clinical procedure,Typically used for the treatment of chronic pain before spinal cord stimulation.

Pinchi Medical

Before 2013, the technology for brain pacemakers was completely monopolized by foreign companies, resulting in high prices. The ex-factory price of dual-channel brain pacemakers was around 30,000 US dollars.After 2014, the domestic brain pacemaker produced by Beijing PINS Medical was launched in China, breaking the long-term monopoly of multinational companies on this technology. The PINS series brain pacemakers are China-produced DBS systems with independent intellectual property rights, offering technical advantages such as 3.0T MRI compatibility, variable frequency stimulation, and remote programming, as well as significant price advantages.Currently, the product has been implanted in over 8,000 patients across more than 200 hospitals in China, accounting for over 60% of the implants in the country, and it has also been exported to four countries including the UK.

At the beginning of 2022, after review by the National Medical Products Administration (NMPA), PINS Medical's innovative product, an implantable spinal cord stimulator, was approved for registration. This alsoIs the first approved implantable spinal cord neurostimulator system produced in China.

Jingyu Medical

In 2014, SceneRay's brain pacemaker was included in the special approval channel for innovative medical devices by China's drug regulatory authority and was approved for marketing in 2016. Its brain pacemaker is equipped with the first domestically developed chip in China's neuromodulation field, featuring dual-frequency proprietary chip technology.Allows the use of different stimulation parameters in different nuclei of the brain, precisely achieving independent frequency programming for the left and right hemispheres. It has cumulatively obtained more than 200 domestic patents in China and more than 10 international patents.

In April 2022, ShenYu Medical's dual-target deep brain stimulation (DBS) technology for the treatment of drug addiction received the Breakthrough Device Designation from the U.S. FDA.This is the first time that a Chinese company has obtained a Breakthrough Medical Device Designation in the field of neurology and psychiatry, marking a new milestone for SceneRay Medical in clinical development and overseas expansion.

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Currently, the global neuromodulation market still holds enormous potential. An increasing number of companies are entering this field, continuously developing new technologies, launching new products, and expanding their indications. As one of the world's top three neuromodulation giants, Abbott has once again solidified its leading position in the industry with the launch of the Eterna™ system, the world’s smallest implantable and rechargeable spinal cord stimulator, which integrates various advantages. How will this product impact the market in the future? Medical Device News will continue to follow up.