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

Category Archives: Technologies

Technologies for implantable devices

Axonics Prevails in Patent Infringement Lawsuit with Medtronic

Posted on by Posted in AIMD Business, Axonics, Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation, Wireless Power Transmission
Axonix rechargeable stimulator

Image Credit: Axonix

Axonix announced that a jury in the U.S. District Court for the Central District of California returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in Axonix favor.

The jury ruled unanimously for Axonics, on claims related to three separate patents.  One relates to transcutaneous recharging, and the other two two  to the implantation of electrodes for stimulating the sacral nerve to help support urinary and bowel control.

The case has been one of several intellectual property disputes between Medtronic and Axonics, which is expected to become a Boston Scientific subsidiary in a $3.7 billion deal.

 

FDA approves Endotronix’s Cordella PA Sensor

Posted on by Posted in Endotronix, Heart Failure (CHF), Sensors

Endotronix announced that it received FDA’s PMA approval for its Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of NYHA class III heart failure patients. According to Endotronix, “The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.”

According to the announcement:

“Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.”

Science acquires assets and clinical studies from Pixium Vision SA

Posted on by Posted in Blindness, Optogenetics, Pixium Vision, Retinal Stimulation, Science

Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision

Science – the company recently started by Neuralink’s co-founder Max Hodak announced that it is acquiring Pixium Vision‘s assets.

Pixium Vision’s Prima system to treat vision loss is implanted in 47 subjects across Europe and the United States.  However, it ran out of cash, and was in danger of abandoning the study.  Science’s acquisition of Pixium’s technology includes the three ongoing clinical trials in late-stage macular degeneration.

Science Eye

Image Credit: Composite of images by Science

On its side, Science is developing the “Science Eye,” which is a combination device comprising Optogenetic gene therapy and an implantable, high-resolution display.  The first part of the procedure consists of a protein nanoparticle used to deliver a gene to some of the retinal ganglion cells, making them light-sensitive at a specific wavelength.  Then, a very small, flexible, high-resolution display film is implanted over the retina to allow fine control of the newly light-sensitive ganglion cells.

In the announcement, Max Hodak stated about the acquisition of Pixium’s competing technology:

“What does this mean for our optogenetic gene therapy and the Science Eye? It’s too early to know which approach, electrical or optogenetic, will work best in the retina long term as these technologies mature. But whichever is used 20 years from now, there is a huge amount of good all of these early devices can do today. They represent very different approaches that make different tradeoffs and at least initially will probably target different patient subpopulations. We would love to be able to offer a range of products to match each individual patient’s needs with the best of what’s available over time.”

Senseonics receives FDA iCGM Designation for Eversense® CGM System

Posted on by Posted in Diabetes, Glucose Monitoring, Senseonics, Sensors
Eversense® Implantable Continuous Glucose Monitoring System

From: Lorenz, Carrie & Sandoval, Wendolyn & Mortellaro, Mark. (2018). Interference Assessment of Various Endogenous and Exogenous Substances on the Performance of the Eversense Long-Term Implantable Continuous Glucose Monitoring System. Diabetes Technology & Therapeutics. 20. 10.1089/dia.2018.0028.

Senseonics in Germantown, MD announced that its Eversense® Implantable Continuous Glucose Monitoring System has received the iCGM designation by the FDA.  iCGM status indicates that Senseonics’ Eversense iCGM product can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system.

According to the announcement:

“As the first fully implantable device in the category, Eversense has been authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.

…  The companies plan to advance partnership discussions with various pump manufacturers, with plans to offer people who choose to integrate their diabetes devices a new interoperable CGM option that is exceptionally well suited for AID systems. This is because Eversense addresses common limitations of AID systems outlined in the 2022 Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.”

The Eversense subcutaneously implantable glucose sensor has been validated for up to 180-day implant periods.  Unlike other  CGM systems that use
electrochemical- and enzymatic- (i.e., glucose oxidase and glucose dehydrogenase) based methods to measure glucose concentrations, the Eversense CGM sensor uses an abiotic (non–enzyme based), fluorescent glucose-indicating polymer to measure glucose.

History: The Pacesetter Rechargeable Human Tissue Stimulator

Posted on by Posted in Alfred E. Mann, Dr. Robert Fischell, Epilepsy, Museum, Neural Stimulation, Pacesetter, Pain, Wireless Power Transmission
Pacesetter Human Tissue Stimulator

Pacesetter Human Tissue Stimulator (HTS) (c) David Prutchi, Ph.D., 2024

I recently acquired this device on eBay® (from a very kind seller, I may add).  Although labeled as a “Rechargeable Pacemaker,” and looks just like the one at the Udvar-Hazy about which I had posted a few years ago, it is in fact a neurostimulator.

The Human Tissue Stimulator or “HTS” was developed subsequently to the rechargeable pacemaker, prompted by the clinical need for a rechargeable implantable neurostimulator.

Continue reading→

Synergia Medical’s NAO·VNS™ Optoelectronic Neurostimulator

Posted on by Posted in Biophan, Epilepsy, MRI-safe, Photovoltaic, Synergia Medical, Vagus Nerve Stimulation
Synergia NAO.VNS optoelectronic stimulator for epilepsy

Image Credit: Synergia Medical

Synergia Medical is a Belgian company founded in 2014 developing a neurostimulation system that powers the stimulation electrodes by photovoltaic conversion of light pulses produced by a generator connected via optical fiber.

The concept is to reduce major metallic components such that the device can be operated while the patient undergoes a functional MRI (fMRI), and hence, according to Synergia, allow the device’s performance to be assessed and optimized at the time of implant. Continue reading→

What happened to the BION®?

Posted on by Posted in Advanced Bionics, Alfred E. Mann, Axonics, Bluewind Medical, Boston Scientific, Electrode Materials, General Stim, Incontinence, Muscular Stimulation, Nalu, Neural Stimulation, Neuspera, Paralysis, University of Southern California, Valencia Technologies
RF-powered Bion stimulator

First-generation RF-powered BION (RFB1) microstimulator. Image Credit: Alfred Mann Institute for Biomedical Engineering

In 1991, Dr. Gerald Loeb, at the time a Professor of Physiology and Biomedical Engineering at Queen’s University (Kingston, Canada), first proposed a miniature, injectable, RF-powered device for the stimulation of tissue or motor neurons. The BION® device was developed based on this concept as a joint project between Queens University (Kingston, ON, Canada), IIT (Chicago, IL), and the Alfred E. Mann Foundation (Valencia, CA) with funding from the NIH Neural Prosthesis Program. The RF BION 1 (RFB1) was then manufactured by the Alfred Mann Institute for Biomedical Engineering at USC.

Continue reading→

The CARSS OpenNerve Device: An Open-Source Neuromodulation System for Autonomic Nerves

Posted on by Posted in CARSS, Med-Ally, Medipace Inc., Neural Stimulation, Sensors

Image Credit: CARSS

The University of Southern California, Medipace Inc., and Med-Ally LLC are the CARSS collaborative team part of NIH’s Human Open Research Neural Engineering Technologies (HORNET) initiative for open-architecture, open-source implantable neuromodulation system.  This team is developing the OpenNerve implantable neuromodulation platform, which consists of an IPG with an associated charging device. The OpenNerve IPG will perform current-based neuromodulation, measure impedance, monitor electronic biosignals, and interface with chemical and physical sensors.

All files relevant to the design and manufacture of the CARSS OpenNerve Platform are available on a Github repository. Details are posted on the project’s Wiki.

Image Credit: CARRS

Interesting poster: Volumetric-energy efficiency of implantable neuromodulators

Posted on by Posted in Neural Stimulation, Technologies

Image Credit: Santiago Martinez, et al.

Santiago Martínez, Francisco Veirano, Timothy G. Constandinou, and Fernando Silveira presented a very interesting poster at the First Workshop on Active Implantable Medical Devices organized at LASCAS 2024.

The complete paper is available from IEEE:

S. Martínez, F. Veirano, T. G. Constandinou and F. Silveira, “Trends in Volumetric-Energy Efficiency of Implantable Neurostimulators: A Review From a Circuits and Systems Perspective,” in IEEE Transactions on Biomedical Circuits and Systems, vol. 17, no. 1, pp. 2-20, Feb. 2023, doi: 10.1109/TBCAS.2022.3228895.

I believe that this paper is especially important for developers in the AIMD Industry since it points out opportunities for improving the volumetric and energy efficiencies of neurostimulators.

Continue reading→

BCI Developer Synchron Acquires Equity Stake in Nitinol Part Maker ACQUANDAS

Posted on by Posted in AIMD Business, ALS, Brain-Computer Interface, EEG Monitoring, Paralysis, Synchron
Synchron stent electrode

Image Credit: Synchron

Brain-computer interface (BCI) developer Synchron announced the acquisition of an equity stake in ACQUANDAS, a provider specializing in  high-precision nitinol components.

Synchron is developing endovascular technology to restore functionality in patients with motor impairment.    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.

First Human Implant of Neuralink BCI

Posted on by Posted in ALS, Brain-Computer Interface, EEG Monitoring, Neuralink, Paralysis, Spinal Cord Injury (SCI)
Neuralink implant

Image credit: Neuralink

Elon Musk posted on X that Neuralink conducted the first human implant of its brain-computer interface:

Image Capture from X

Details are scant at this time, but Neuralink announced back in September ’23 that they had started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).

Endotronix Submits PMA Application for the Cordella PA Sensor

Posted on by Posted in Endotronix, Heart Failure (CHF), Sensors

Endotronix, announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the FDA.

According to the announcement:

“Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home. Its user-friendly devices securely transmit daily health information to the managing clinician, supporting optimal dosing of guideline-directed medical therapy (GDMT) to reduce congestion and engaging patients with trended health data to enable healthy lifestyle choices.”

In April 2023 Endotronix completed the enrollment of its PROACTIVE-HF pivotal study.  Primary endpoint data from the trial is expected to support the PMA Application.

 

Impulse Dynamics receives full-body MRI-conditional approval for OPTIMIZER Smart Mini System

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

OPTIMIZER Smart Mini whole-body MRI

Impulse Dynamics, the company for which I am the CTO, announced that FDA has approved full-body MRI-conditional labeling for the OPTIMIZER Smart Mini IPG.  According to the announcement:

“The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.”

ONWARD® Announces First-in-Human Implant of ARC-IM™ with BCI to Restore Arm, Hand, and Finger Function after SCI

Posted on by Posted in Brain-Computer Interface, EEG Monitoring, Neural Stimulation, Onward, Paralysis, Spinal Cord Injury (SCI)
ONWARD ARC device with BCI

Image Credit: ONWARD

Onward announced the successful first-in-human implant of its ARC-IM Stimulator, to restore upper extremity function after SCI. The patient also received a wireless brain-computer interface (BCI), designed to initiate thought-driven movement when paired with ARC-IM.

According to the announcement:

“Working in concert with ARC-IM, the BCI is engineered to capture the intention of a paralyzed individual to move their upper extremities and uses artificial intelligence to decode those thoughts. ARC-IM then converts the decoded information into ARC-IM Therapy – precise stimulation of the spinal cord – resulting in thought-driven movement.”

 

 

Neuralink Announces that First-in-Human Clinical Trial is Open for Recruitment

Posted on by Posted in ALS, Brain-Computer Interface, EEG Monitoring, Neuralink, Spinal Cord Injury (SCI)
Neuralink implant

Image credit: Neuralink

Neuralink announced that they have started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).  The study will assess the initial functionality of Neuralink’s BCI for enabling people with paralysis to control external devices with their thoughts.

According to the announcement:

During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.

The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.

Those who have  may qualify.