A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Technologies

Technologies for implantable devices

FDA Accepts Zurich MedTech’s IMAnalytics and Field Exposure Libraries as a Medical Device Development Tool

Posted on by Posted in MRI-safe, Tech Talk

Image Credit: Zurich MedTech

The FDA announced the acceptance of Zurich MedTech’s Sim4Life IMAnalytics and the field exposure libraries MRIxVIP1.5T and MRIxViP3.0T from the IT’IS Foundation as a Medical Device Development tool (MDDT).  This is the first FDA-approved computational modeling Medical Device Development Tool.

IMAnalytics is a software platform for the safety evaluation of implantable devices in the Magnetic Resonance (MR) environment. It characterizes RF-induced heating at the distal electrodes of implantable devices, using a variant of the Tier 3 approach as defined in ISO/TS 10974. It is tailored for elongated lead structures by making use of the transfer function method described in Annex K of the same technical specification.

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First Clinical Implant of Synchron’s Stentrode® Minimally-Invasive Neural Interface

Posted on by Posted in ALS, Brain-Computer Interface, Muscular dystrophy, Spinal Cord Injury (SCI), Stroke, Synchron
Stentrode by Synchron

Image Credit: Synchron

Synchron Inc. announced today the first successful clinical implantation of the Stentrode®, a minimally-invasive neural interface technology, a component of the Synchron Brain-Computer Interface. This is the first clinical feasibility trial evaluating this technology for its potential to restore communication in people with severe paralysis.

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iota Biosciences’ “Neural Dust”

Posted on by Posted in iota Biosciences, Neural Stimulation, Telemetry, Ultrasound

Image Credit: iota Biosciences

iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.

iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator.  According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound.  Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease

In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform.  In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”

Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.

iota Biosciences’ website is at: https://iota.bio/

Can the Government Really Read Your Mind using Brain Implants? (Spoiler Alert: NO, they Can’t!)

Posted on by Posted in Brain-Computer Interface

I’ve stopped watching CNN, because it has become as bad and radically polarized as FOX news is on the other side of the spectrum, so it was an external reference that sent me to the following CNN article by Dominic Rech:

“Brain implants could give governments and companies power to read your mind, scientists warn“

So… now CNN is not only the mouthpiece for the far left, but like FOX News (which I consider a parody channel) has also turned into a pusher of ridiculous conspiracies.

Sure, neural implants can read specific motor patterns that, with exhaustive training of the subject, can be used as a brain-machine interface.  However, that is an extremely far cry from being able to surreptitiously read someone’s mind or implant thoughts into people (AKA “synthetic telepathy”).

CNN’s Rech quotes a report by Dr. Tim Constandinou and his colleagues at the Next Generation Neural Interfaces (NGNI) Lab at Imperial College London.  However, the report doesn’t imply anything of the sort of the sensationalistic title chosen by CNN.

Bottom line:  NO, the Government and Private Companies will not be able to either read or place thoughts into your mind any time soon through brain implants!

Now, my main issue isn’t that CNN is using a ridiculous headline as click bait, but rather it is the fact that such reporting is irresponsible and outright dangerous.

Despite a clear notice that I won’t address such queries, I still receive copious amounts of e-mail messages from people who believe that they have been surreptitiously implanted with electronic devices to harass and spy on them.  Mr. Rech’s article recklessly provides fuel for such psychotic thoughts, and legitimizes a conspiracy that discourages these people from receiving the psychiatric care they so critically require.

Shame on you Dominic Rech and CNN!

 

 

 

 

FDA Approves Boston Scientific’s ImageReady™ MRI For Vercise Gevia™ DBS

Posted on by Posted in Boston Scientific, Brain Stimulation, MRI-safe, Parkinson's Disease

 

Image Credit: Boston Scientific

Boston Scientific announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™  Deep Brain Stimulation (DBS) System to be used in a full-body MRI (1.5 Tesla MRI conditional when all conditions of use are met).  This system, with the Vercise Cartesia™ Directional Lead, is designed to treat the symptoms of Parkinson’s Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.

 

Synchron’s Stentrode™ Endovascular Neural Interface for BCI

Posted on by Posted in Brain-Computer Interface, Paralysis, Synchron
Stentrode by Synchron

Image Credit: Synchron

Synchron is a Silicon Valley company that spun out of the University of Melbourne, Australia in 2012. It was started by Thomas Oxley, MD, PhD to develop a new concept for a Brain-Computer Interface

Synchron’s Stentrode™ is an endovascular neural interface. It is essentially an electrode array shaped as an endovascular stent that can be implanted via the jugular vein and advanced into the brain to the motor cortex. Neural signals are detected by the electrodes on the Stentrode™ and sent to a processing and communications unit implanted subcutaneously in the chest, and then wirelessly to an external receiver. The idea is that the device can interpret signals from the brain for patients with paralysis to control a computer operating system and set of applications that interact with assistive technologies.

Synchron is currently preparing for pilot clinical trials of the Stentrode™ to evaluate the safety and efficacy of this breakthrough technology.

Synchron’s website is at: https://www.synchronmed.com

Conceptual use of the Stentrode device
Image Credit: University of Melbourne

Leviticus Cardio’s Coplanar Energy Transfer for Powering Ventricular Assist Devices

Posted on by Posted in Coplanar Energy Transfer, Heart Failure (CHF), Jarvik Heart, Leviticus Cardio, Ventricular Assist Device, Wireless Power Transmission
Leviticus Cardio FIVAD

Image Credit: Composite of images by Leviticus Cardio

Leviticus Cardio, a company based in Petach Tikva, Israel, has been developing a wireless power transfer technology that they call “Coplanar Energy Transfer” (CET). The system supports high-efficiency (up to 75%) power transfer levels of up to 30 Watts, making it suitable for powering ventricular-assist devices.

Like other transcutaneous energy transfer systems, Leviticus is used on inductive power transfer between an external primary coil and an implanted secondary coil. However, instead of the traditional pancake coil subcutaneous implant, the CET coil is placed around the lung. The unique engineering of the coplanar energy transfer system is characterized by two large rings utilizing a coil-within-the-coil topology, ensuring robust resonance energy transfer Continue reading→

Bioness’ StimRouter Implantable Neurostimulator Reroutes TENS Pulses

Posted on by Posted in Bioness, Pain, PNS, Sacral Root Stimulation, Spinal Cord Stimulation, Wireless Power Transmission

Bioness' StimRouter implantable neurostimulator. www.implantable-device.com David Prutchi PhD

Bioness is a Valencia, California medical device/rehabilitation company founded by the late Alfred Mann some 15 years ago. He had previously acquired a miniature stimulator called the BION, and a company called NESS who had a footdrop stimulator. The combination of the two is where the name Bioness came from.

One of its products is the “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. It gained FDA approval in 2015 and was launched in mid-2016.

Unlike most externally-powered neurostimulators however, the StimRouter is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.

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Vectorius Medical’s V-LAP Left Atrial Filling Pressure Sensor

Posted on by Posted in Heart Failure (CHF), Sensors, Vectorius Medical

Image Credit: Vectorius Medical

Vectorius Medical was founded in 2011 in the RadBioMed incubator in Tel-Aviv, Israel. It developed the V-LAP implantable device for the measurement of Left Atrial Filling Pressure (LAP).

The device is implanted in the left atrium, has no battery, and is able to communicate with an external interrogator from deep within the body using high-resolution waveform morphology. According to Vectorius Medical:

“Since the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, the actionable feedback provided by the V-LAP will enable a significant improvement in ongoing management of heart failure patients. Once patients are implanted with the V-LAP, they will be able to measure left atrial pressure (LAP) daily at home via an easy, non-invasive method using a small, portable external unit.

…

Left atrial pressure has been scientifically established as the most specific physiological indication for heart failure exacerbation. Approximately 90% of patients admitted to the hospital for heart failure have pulmonary congestion related to elevated left atrial filling pressure (LAP). The increase of LAP is the earliest sign of impending heart failure exacerbation – long before clinical symptoms occur.”

The Vectorius system is intended to provide daily readings patient hemodynamic pressure to provide early, accurate physiological indication of cardiac decompensation. Physicians can access data through a Cloud-based system.

On February 4, 2019, Vectorius announced the initiation of the VECTOR-HF First-in-Human (FIH) clinical trial, and the successful first ‘in-human’ implantation of the V-LAP monitoring device. According to Vectorius Medical:

“Implantation of the device in this first “In-Human” trial was completed in just six minutes. It was fixated within the patient’s interatrial septum of the heart using a standard minimally-invasive percutaneous procedure under fluoroscopy and echocardiographic guidance, with the application of local anesthesia.”

Vectorius’ website is at: http://vectoriousmedtech.com

Neuspera Raises $26M Series B for its Miniature Neuromodulation Implants

Posted on by Posted in Neural Stimulation, Neuspera, Neuspera Mid Field Powering, Wireless Power Transmission

Neuspera’s Mid-Field Powering technology. Image credit: Neuspera

Neuspera is a startup company located in San Jose, CA.  They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.

According to Neuspera, their “Mid-Field Powering” technology uses evanescent and propagating electromagnetic waves to power implanted medical devices to beyond 10cm of depth. Their technology is claimed to use the body as a natural waveguide to focus power ensuring energy is delivered to where it is needed.

In addition to coming up with their own neuromodulation system, Neuspera hopes to license its Mid-Field Powering technology to recharge or power other types of implantable devices.  According to their technical publications and patent, they use a phased array microwave transmitter operating at a 1.6GHz local minimum in tissue absorption to maximize power transfer.  Per the patent, if the power coupled into tissue is allowed to meet the maximum permitted level of exposure, up to 2.2 mW can be transferred by their system.

Neuspera Medical announced that it has raised a new total of $26 million in equity financing, following the closing of the second tranche of its series B round, to help fund clinical testing programs for its neuromodulation implants.

A vide explaining Neuspera’s technology is available at:

Neuspera Medical from Tiffany Wise on Vimeo.

Neuspera’s website is: http://neuspera.com

Pacesetter’s 1973 Rechargeable Pacemaker

Posted on by Posted in Alfred E. Mann, Cardiac Pacing, Dr. Robert Fischell, History, Museum, Pacesetter, Power Sources, Rechargeable Batteries, Wireless Power Transmission

Demo of a rechargeable Pacesetter pacemaker at the Udvar-Hazy Center. www.implantable-device.com, David Prutchi PhD

Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA.  There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation:

Demo of a rechargeable Pacesetter pacemaker at the Udvar-Hazy Center. www.implantable-device.com, David Prutchi PhD

Pacesetter model BD102 VVI rechargeable pacemaker www.implantable-devices.com David Prutchi PhDI can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it is documented by Kirk Jeffrey in “Machines in our Hearts”:

“In 1968, Robert Fischell, of the Applied Physics LOaboratory at Johns Hopkins University, and cardiologist Kenneth B. Lewis had begun a collaboration that led in 1973 to a new kind of Ni-Cad battery able to function more effectively at body temperature and hermetically sealable.  Alfred E. Mann, a California entrepreneur with background in the aerospace industry, had provided some financial support to the Hopkins group.  Eventually Mann founded a small company to develop a pacemaker for the rechargeable battery; this was the origin of Pacesetter Systems.  The rechargeable pacemaker reached the market in the summer of 1973, just as CPI introduced its lithium pacer.”

 

Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, Sorin

Sorin Kora 100 MRI pacemaker David Prutchi PhD www.implantable-device.com

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system.

According to the press release:

KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population is prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.

The KORA 100 pacing system has been designed with both patients and physicians in mind. Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.

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AAMI Technical Information Report Gives Guidance to AIMD Designers Regarding MRI Compatibility

Posted on by Posted in MRI-safe, Tech Talk

AAMI Guidance Implantable Device Compatibility with MRI

A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans.

ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform manufacturers about device behavior and patient risks so that MR-conditional AIMDs can be designed and labeled appropriately.  The introduction to the TIR explains:

Test methods described in this Technical Specification are primarily designed and intended as bench-top tests using equipment and techniques to simulate the fields (B0 static, gradient, and RF) found in MR 1.5 T scanners. Although, in a few cases, clinical scanner tests are implied, in all others, the AIMD manufacturer assumes the burden for development and validation of clinical scanner-based test methods.  Furthermore, the test signals and parameters specifically described within this Technical Specification for bench-top testing are not being encouraged or recommended for use on clinical scanners and to do so might result in scanner damage.

WISE s.r.l. Raises €1M to Develop Flexible Electrodes for Spinal Cord Stimulation

Posted on by Posted in Electrode Materials, Spinal Cord Stimulation

Supersonic Cluster Beam ImplantationWISE (Wiringless Implantable Stretchable Electronics), a Milan- and Berlin-based medical device companyraised a seed-round of € 1 M to advance the development of its first product aimed at the spinal cord stimulation market.

WISE’s technology relies on Supersonic Cluster Beam Implantation (SCBI) for the metallization of polymers and elastomers. SCBI allows to fabricate complex microelectronic circuits and interconnects on stretchable and conformable supports that preserve their electrical performances after extensive cycles of stretching and bending of the substrates. The devices can be efficiently fabricated on biocompatible platforms, and are therefore suitable for the production of implantable biomedical devices.

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Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

Posted on by Posted in Diabetes, Drug Delivery, Senseonics, Sensors, Sensors for Medicine and Science, Telemetry, Ultra-Low-Power ICs

Senseonics implantable glucose sensor www.implantable-device.com David Prutchi PhDSenseonics implantable glucose sensor www.implantable-device.com David Prutchi PhD

The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD).

Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered with Senseonics and developed a new microchip for use in Senseionics’ fluorescence-based implantable glucose sensor. According to the article, “ZMDI’s design specifications for this application-specific integrated circuit (ASIC), which is implemented as a system- on-a-chip (SoC) for control and analysis had to meet the following main requirements: LED driver, measurement and analysis of reflected light, data pre-processing, memory, wireless interface for data transfer, no battery due to extremely low power and low voltage requirements, medical certification, and special form factor.”

Click here for the online article.  Click here for a local pdf printout.