Medtronic's Percept™ PC, the World’s First Sensing-Enabled Deep Brain Stimulation System, Receives NMPA Approval

Source: Instrument Family, no reprinting without authorization, and reprinting is allowed 24 hours later.

On October 10, Medtronic announced that,Its Percept™ PC, the world's first deep brain neurostimulator with sensing technology, has been approved by the National Medical Products Administration (NMPA) in China.This product is suitable for the treatment of Parkinson's disease, essential tremor, epilepsy, and dystonia.

According to reports,The Percept™ PC system received CE Mark approval in Europe and began its launch in Europe in early 2020; in June 2020, the product received FDA approval in the United States.

Instrument Family

Deep Brain Stimulation (DBS) is a conventional treatment for Parkinson's disease, essential tremor, dystonia, and drug-resistant epilepsy.And has begun to be extended to other neuropsychiatric disorders, such as major depression and Alzheimer's disease. In addition, due to the minimally invasive nature of DBS surgery and fewer severe adverse effects, there is potential for application in conditions like tinnitus, arterial hypertension, and sleep disorders.

01

Medtronic's First Global Product with Sensing Technology

DBS Stimulator Approved by NMPA

Data shows that the Percept™ PC system is a device similar to a pacemaker, which can be implanted subcutaneously in the patient's torso. Its leads are connected to brain regions associated with specific neurological disorders.What sets this device apart from other deep brain stimulation systems is that, in addition to providing neurostimulation therapy for treating diseases such as Parkinson's disease, epilepsy, and obsessive-compulsive disorder, it can also continuously capture and record brain signals.

The Percept™ PC Neurostimulator uses BrainSense™ technology to capture brain signals from patients, providing clinicians with objective data directly from the brains of DBS (Deep Brain Stimulation) patients.To understand the impact of treatment decisions (such as changes in medication or stimulation).BrainSense™ technology uses implanted DBS leads to capture brain signals (local field potentials or LFPs),Improved insulation of the Percept™ PC neurostimulator enhances LFP detection, allowing its LFP to be 1 million times smaller than DBS stimulation pulses.

These signals can be recorded simultaneously while providing therapeutic stimulation both inside and outside the clinic. Healthcare providersThe collected data can be used to map each patient's brain response to stimulation or medication, as well as the manifestation of symptoms and side effects in brain activity, thereby helping to develop more effective and personalized treatment plans.

Besides,Percept™ PC is also equipped with the OPTISTIM™ Control Center, OptiStim™ and ShapeLock™ controls, and the multi-rate function from 16 independent current sources in the Percept™ PC device.Enabling OptiStim™ Control allows unique amplitude values to be assigned to each electrode.

According to reports,Percept™ PC is the world's first deep brain neurostimulator with sensing technology, and also the first internationally to capture and record.Deep Brain Stimulator with Local Field Potential Signals,And it can be compatible with both 1.5T and 3.0T MRI scans while powered on.

The birth of the Percept™ PC with perceptible functionality marks the entry of DBS (Deep Brain Stimulation) into the digital age.It is reported that Percept™ PC can transmit the EEG signals it captures to the doctor's end through near-field communication, especially the beta-band signals it captures.This will significantly enhance the effectiveness of DBS therapy and open a new door for humanity's research into brain science.

02

DBS Technology Receives Widespread Attention

The application space will be unlimited.

According to statistics, the number of Parkinson's disease patients in China has exceeded 3 million and will reach 5 million by 2030. In addition, there are over 10 million Alzheimer's disease patients in China.Accounting for one-third of the global total, there are nearly 10 million people with epilepsy in China, with an annual increase of 400,000 new cases, of which 30% are drug-resistant epilepsy.

In recent years,Deep brain stimulation (DBS) technology has received increasing attention and is already widely used clinically for movement disorders caused by diseases such as Parkinson's.At the same time, it has great potential in central nervous system diseases such as anxiety, depression, refractory epilepsy, and intractable obsessive-compulsive disorder.

DBS therapy uses stereotactic technology to implant electrodes into certain deep brain regions, which are controlled by an implantable pulse generator (IPG) placed subcutaneously below the clavicle.Electrodes emit electrical pulses to stimulate targets and modulate neural function, ultimately achieving the goal of treating neurological and psychiatric disorders.

DBS Diagram

IPG contains a battery and electronic components that deliver electrical stimulation. It can be controlled by both patients and clinicians, who can regularly adjust stimulation parameters such as frequency, pulse width, and voltage to maximize the neuromodulatory effects of DBS.

In 1997, the U.S. FDA approved Medtronic's application to use DBS for treating essential tremor and Parkinson's disease.

Currently, more than 180,000 patients worldwide have undergone DBS implantation. Follow-up studies on implanted cases show that DBS is highly effective in controlling motor symptoms of Parkinson's disease and reducing medication intake.

Recent research results show that,DBS is expected to be applied to a variety of diseases, including chronic pain, obsessive-compulsive disorder (OCD), and depression, among others. In addition, scientists are already experimentally exploring the efficacy and safety of DBS therapy for conditions such as drug addiction, anorexia, obesity, and Alzheimer's disease.As research on DBS continues to advance, the future application scope of DBS therapy will be limitless.

03

The Layout of the Three Global Giants in Neuromodulation

Data shows,The United States is currently the largest production and consumption market for implantable neurostimulators globally, 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.

Facing a huge potential market, multiple companies in China have joined the competition in neuromodulation.Besides Medtronic, Abbott, and Boston Scientific, the three giants in the neuromodulation market,Companies such as LivaNova, Nuvectra, Nevro, NeuroSigma, NeuroPace, and Neuronetics have made strategic deployments in neuromodulation.

Among them,Neuro modulation products from seven major players — Medtronic, Abbott, Boston Scientific, LivaNova, Nevro, Nuvectra, and NeuroPace — occupy the vast majority of the global market share.Is the leader in the top four细分 markets of spinal cord stimulation (SCS), deep brain stimulation (DBS), vagus nerve stimulation (VNS), and sacral nerve stimulation (SNS).

Next, let's take a look together.The Layout of Medtronic, Abbott, and Boston Scientific in the Field of Neuromodulation:

Medtronic

Medtronic's leading position can be attributed to its extensive portfolio of neuromodulation devices and strong geographic coverage.Medtronic has strong product and technical support in the four major 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, making adjustments 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 assessment systems and intelligent programs.

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

Abbott

Abbott's neuromodulation products originated from the acquisition of St. Jude Medical, with its product line centered around Proclaim XR and Proclaim DRG. Currently,Abbott mainly focuses on the treatment of chronic pain and movement disorders, with its products primarily distributed across three major areas: spinal cord stimulation, deep brain stimulation, and dorsal root ganglion stimulation (DRGS).

Spinal Cord Stimulation:Proclaim™SCS System, Invisible Trial System.Among them, the Invisible Trial system is application-based and utilizes iOS mobile digital devices for patient treatment evaluation.

Dorsal Root Ganglion Stimulation: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.

Deep Brain Stimulation:ST. JUDE MEDICAL™ Infinity DBS System.Among them, the pulse generator communicates with the brain through wires, and iOS devices enable doctors to adjust settings for personalized treatment.

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, location, and orientation 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 for 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 prior to spinal cord stimulation.

04

Neuromodulation Welcomes a Market Size of Tens of Billions

Chinese companies start to catch up and make strategic moves

According to research data,In 2018, the global production of neurostimulators was approximately 189,900 units, with sales reaching about 4 billion US dollars, while the market production of neurostimulators in China accounted for only about 1.63% of the global share.

Currently, the global neuromodulation market is predominantly occupied by three major giants: Medtronic, Abbott, and Boston Scientific. In recent years,A number of domestically produced enterprises have emerged in the field of neuromodulation devices, such as SceneRay Medical, PinChi Medical, etc., with broad space for domestic substitution.

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, 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 more than 8,000 patients across over 200 hospitals in China, accounting for over 60% of the implants in China, 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 implantable spinal cord stimulator product 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 authorities 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 brain nuclei, precisely achieving asynchronous bilateral brain programming. It has cumulatively obtained more than 200 domestic patents in China and more than 10 international patents.

In April 2022, Jingyu 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 breakthrough medical device qualification in the field of neurology and psychiatry, marking a new milestone for SceneRay Medical in clinical development and overseas expansion.

——

Currently, the global neuromodulation market is largely dominated by three major giants: Medtronic, Abbott, and Boston Scientific. Notably,In response to the significant demand for chronic disease management, relevant companies both in China and abroad have entered this field, continuously developing new technologies and launching new products to expand their indications.

So,With the approval of Medtronic's Percept™ PC in China, as a leading company in the field of neuromodulation, what impact will this product from Medtronic have on the domestic market?What kind of development situation will Chinese-produced neuromodulation related companies face in the future? DeviceHome will continue to follow up.