Active implantable medical devices for brain stimulation
Image credit: Neuralink
Yesterday Neuralink announced that its Blindsight Device had been granted “Breakthrough Device” designation by the FDA. According to Elan Musk, the device “will enable even those who have lost both eyes and their optic nerve to see.”
Details about the Blindsight Device or commencement of a clinical trial are scarce at this time.
Image Credit: Abbott
Back in 2022, the FDA granted Abbott Breakthrough Device designation for deep brain stimulation (DBS) for treatment-resistant depression (TRD), a form of major depressive disorder. Now Abbott announced it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company’s DBS system to manage TRD.
Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.
Image Credit: Zamora et al https://doi.org/10.1101/2020.09.10.292284
UK news outlets reported that a Picostim deep-breain stimulator made by UK company Bioinduction (which was recently acquired by Amber Therapeutics) was recently implanted in a boy with Lennox-Gastaut syndrome, which is a a severe, treatment-resistant form of epilepsy that he developed at the age of three.
The implant was performed at the UCL Great Ormond Street Institute of Child Health & Great Ormond Street Hospital under the “CADET” project (Children’s Adaptive Deep brain stimulation for Epilepsy Trial). According to the project’s website, the Picostim system is especially suitable for DBS therapy in this application:
“The advanced capabilities of Picostim DyNeuMo-1 allow for personalised and adaptive stimulation regimes according to seizure patterns and circadian (wake/sleep) rhythms at an individual patient level, which are key components of LGS symptoms. These capabilities are here proposed to maximize the potential of DBS to limit seizure spread, and reduce seizure frequency and severity.
These capabilities are made possible by the ability to non-invasively and repeatedly recharge the device. Patients or parents are able to use a handheld or headset-mounted charger that safely recharges the battery through the skin.
The device allows for the recording of electrical activity in the implanted brain, potentially allowing stimulation parameters that are tailored to LGS and to the individual child.
Lastly, the whole device is mounted to the skull, removing the need for (painful) tunneling of extension leads to a battery implanted in the chest wall and potentially reducing the risk of infection.”
The CADET pilot (Children’s adaptive deep brain stimulation for epilepsy trial) will now recruit three additional patients with Lennox-Gastaut syndrome, with a view to 22 patients being recruited to take part in a full trial.
Image Credit: CADET Project, UCL Great Ormond Street Institute of Child Health
Image Credit: CorTec
CorTec is a neurostimulation company based in Freiburg, Germany developing the closed-loop “Brain Interchange Implant System.” This is an implantable device is capable of recording and stimulating on 32 channels under the wireless control of an External Unit which also powers the device. Application Software on a computer connected to the External Unit manages the telemetry and analyzes signals acquired by the implant. The computing unit then uses parameters provided by the application software to generate stimuli in the brain and nerves.
CorTec announced that the US FDA approved and IDE application by the University of Washington School of Medicine to use the Brain Interchange Implant System as a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain. Continue reading
The 2015 “Made in China 2025” and subsequent domestic development initiatives have significantly benefited Chinese medical device manufacturers. The 2015 plan prioritized the expansion of high-tech device production with the goal of supplying 70% of China’s device market by 2025. More recently, in 2021, the Chinese government issued the 14th five-year plan (2021–25) that aims at making at least six Chinese companies reach the top 50 revenue-making medical device companies globally.
I was recently chatting with Victor Pikov at the First AIMD Workshop, and he mentioned that in the last couple of years the number of Chinese AIMD manufacturers have grown from 5 to over 10. I was really surprised about the progress that China has made in the AIMD field, so this blog expands on the list of Chinese AIMD companies that Victor compiled and kindly shared with me. Continue reading
Image Credit: Abbott
Abbott announced that it received FDA’s approval for its Liberta RC DBS system, which is the world’s smallest rechargeable deep brain stimulation (DBS) device with remote programming, to treat people living with movement disorders. According to the press release:
“At approximately the height and width of a smartwatch face, the Liberta RC DBS system is about 31% smaller than other commonly used implantable, rechargeable DBS devices currently available in the U.S. When used under standard settings, Abbott’s Liberta RC DBS system needs to be recharged as few as every 37 days – or 10 times a year – using a wireless charger that is placed over the device. For users who prefer a weekly charging schedule, only 30 minutes of charging is needed. The wireless charging system allows people to be active while wearing it and can fully recharge the Liberta RC DBS system twice before needing to be plugged in again. The system, which can be controlled on an Abbott supplied patient controller or a compatible and secure iOS device, offers users helpful notifications and customizable settings for a personalized charging experience”
Image Credit: Motif
Rice University announced that Motif Neurotech, which was formed through the Rice Biotech Launch Pad, closed a Series A financing round of $18.75 million. According to the press release:
“Proceeds from the Series A financing will be used to advance the development of Motif’s lead product, the DOT microstimulator, a miniature brain pacemaker that is designed to precisely stimulate the brain to restore healthy circuit activity to treat mental health disorders. The initial indication Motif is pursuing for the device is treatment-resistant depression (TRD), a form of major depressive disorder (MDD).”
Image Credit: Medtronic
Medtronic announced the FDA approval of its Percept™ RC rechargeable Deep Brain Stimulation (DBS) system. Ths sensing-enabled IPG allows the physician to personalize treatment for patients with movement disorders such as Parkinson’s disease, essential tremor, and dystonia, as well as epilepsy.
According to the press release:
“Percept™ RC is the smallest and thinnest dual channel neurostimulator available for DBS. It is equipped with BrainSense™ technology that captures and records brain signals to provide insights that enable a healthcare provider to adapt and personalize therapy to a patient’s evolving needs. Unlike other rechargeable devices, the Percept™ RC battery offers at least 15 years of service life with consistent and fast recharge performance. Medtronic patented battery technology has less battery fade than other rechargeable devices for a more reliable, long-lasting battery. Patients can experience rapid recharging from 10% to 90% full charge in less than an hour.”
Image Credit: Motif Neurotech
Motif Neurotech, based in Houston, TX is developing a “pea-sized” implantable brain stimulator intended for the treatment of depression.
An interesting preprint was published by Motif’s engineers in collaboration with researchers at Rice University, Baylor College of Medicine, and UTHealth Houston on their millimeter-sized battery-free epidural cortical stimulators. The paper discusses the engineering of the implant, a 30-day porcine study, as well as an intra-operative human test of the device.
Motif’s concept is to implant the device through a simple outpatient procedure, and having the patient periodically wear at home a headset that transmits power to the implant to deliver episodic neuromodulation.
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Image Credit: NeuroPace
NeuroPace of Mountain View, CA announced last month that it filed with the SEC to raise up to $75 million in an initial public offering. However, the IPO was upsized from the initial expectations, with the company offering 6 million shares of common stock at $17 per share, totaling gross proceeds of $102 million. It shares began trading on April 21, 2021 on the Nasdaq under the NPCE ticker.
On April 26 NeuroPace announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at the initial public offering price of $17.00 per share. The gross proceeds to NeuroPace, before deducting underwriting discounts and commissions and offering expenses, were approximately $117.3 million.
Shares rose above $24 after the first day of trading, and have remained steady, closing at $25.78 today.
Unlike Cyberonics’ VNS IPGs, the RNS® neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.
Back in March of 2020, Second Sight Medical announced that it was winding down its operations. Second Sight developed implantable devices intended to create an artificial form of useful vision for blind individuals. However, because of the impact of COVID-19 on its ability to secure financing, it laid off the majority of its employees as a first step to an orderly wind-down of its operations.
The company had developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain. At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients. Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.
On January 6, 2021, Second Sight and France’s Pixium Vision announced that they have entered into a definitive business combination agreement pursuant to which Pixium Vision will, following the contribution to Second Sight of all of its assets and liabilities in relation to its neuromodulation technology used in the treatment of blindness, become the controlling shareholder of the new combined company, owning 60% of the total equity before the capital raise. The combined company will focus on retinal stimulation through Pixium’s Prima System. As part of the transaction, a new subsidiary will be created to focus on cortical stimulation through Orion. The new combined company will own 40% of the new subsidiary and will also have a first option to exclusive global marketing rights for Orion.
Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision
Image Credit: Boston Scientific
Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus™ Deep Brain Stimulation (DBS) System. According to the announcement, The portfolio consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, MR-conditional, implantable pulse generators (IPGs) that power Cartesia™ Directional Leads.
Image Credit: Medtronic
Medtronic announced that it received FDA approval for the Percept™ PC Deep Brain Stimulation (DBS) system.
According to the announcement:
“BrainSense™ technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder (OCD). Physicians can now track patient brain signals and correlate these with patient-recorded actions or experiences, such as symptoms, side-effects, or medication intake. This enables more personalized, data-driven neurostimulation treatment.
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In addition to BrainSense technology, the Percept PC DBS system features several leading-edge innovations, including:
Image Credit: Nuvectra
Back in 2013, implantable-grade component manufacturer Greatbatch Medical (now Integer Holdings) briefly entered the finished devices market with its own Algostim Spinal Cord Stimulator.
However, when Greatbatch acquired CCC Medical in 2014, having the Algostim SCS was seen as a conflict of interest by some of CCC’s SCS customers (e.g. Nevro), so in 2015/2016 Greatbatch divested its SCS business into a new company called Nuvectra.
Nuvectra never caused much of an impact in the SCS market, and trailed well behind Abbott, Boston Scientific, Medtronic, and Nevro. After limping along for a number of years, on November 12, 2019, Nuvectra filed for Chapter 11 bankruptcy.
Cirtec Medical, a competitor of Integer’s CCC in the development of implantable devices, acquired Nuvectra’s IP and assets. Cirtec intends to leverage this technology to support customers’ development of neuromodulation products, providing an FDA approved platform with a complete design history file for a variety of therapeutic applications.
The Nuvectra assets acquired by Cirtec include all owned intellectual property associated with the SCS, SNS, and DBS platforms developed by Nuvectra.