Edwards announced the acquisition of Endotronix, the maker of the Cordella implantable pulmonary artery pressure sensor that allows for early, targeted therapeutic intervention and was recently approved by FDA.
Category Archives: AIMD Companies
FDA recalls 32 Inspire model 3028 IPGs
Image Credit: Inspire Medical
FDA has recalled 32 Inspire IV model 3028 IPGs due to a manufacturing defect which can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the neurostimulator IPG and restore therapy for obstructive sleep apnea.
According to the recall announcement:
“The use of affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in – loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death.
There have been no reported injuries. There have been no reports of death.”
FDA approves Endotronix’s Cordella PA Sensor
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.”
Picostim DBS device implanted in child with Lennox-Gastaut syndrome
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
Science acquires assets and clinical studies from Pixium Vision SA
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.
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.”
CorTec’s Closed-Loop Brain Interchange system receives IDE approval for use in rehabilitation from stroke
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
Aria CV’s device for pulmonary hypertension – No battery, pump, or electronics
Image Credit: Aria CV
Aria CV, based in St. Paul, Minnesota, was founded in 2010 to develop an implantable device intended to treat pulmonary arterial hypertension.
The Aria CV device is an implantable gas-filled balloon that is introduced percutaneously and functions in the main pulmonary artery to alleviate the excessive workload on the right heart that results in right heart failure. The device is designed to restore pulmonary artery health and elasticity, reducing the workload on heart muscles and increasing blood flow by mimicking the function of healthy vessels, which helps the heart pump at a more normal rate and improves blood flow to the lungs. Continue reading
Senseonics receives FDA iCGM Designation for Eversense® CGM 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.
FDA Approves Medtronic’s Inceptiv™ Closed-Loop SCS
Image Credit: Medtronic
Medtronic announced that it received FDA’s approval for its Inceptiv™ closed-loop spinal cord stimulation system for the treatment of chronic pain.
According to the press release:
“Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device’s stimulation output, resulting in a suboptimal therapy experience.
By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician’s prescribed stimulation that is tailored to a patient’s needs. Specialized circuitry and a proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body’s response to stimulation 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.”
History: The Pacesetter Rechargeable 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.
Teliatry’s ReStore Stimulator
Image Credit: Teliatry
Teliatry is a company based in Richardson, TX that is developing the ReStore batteryless, wireless neurostimulator. The glass-encased stimulator was developed in collaboration with the Texas Biomedical Device Center (TXBDC) at The University of Texas at Dallas.
A first device using this stimulator is a Vagus Nerve Stimulator with integrated platinum electrodes, for which TXBDC has received FDA approval for pilot studies in the treatment of PTSD and to enhance recovery following a spinal cord injury. Teliatry expects their platform to be also usable for superficial (< 4cm deep) nerve stimulation delivering up to 5mA pulses, as well as a neuromodulation R&D platform suitable for studies involving small animals.
Synergia Medical’s NAO·VNS™ Optoelectronic Neurostimulator
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®?
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.
FTC scrutinizing Boston Scientific’s $3.7B bid to acquire Axonix
Image Credit: Axonix
In January of this year Boston Scientific announced it had entered into a definitive agreement to acquire Axonics a publicly-traded developer of devices to treat urinary and bowel dysfunction. The purchase price was set at $3.7B. However, the proposed deal is facing scrutiny by the FTC, most probably because the companies are dominant providers of some treatments for incontinence.
The Axonics product portfolio includes the Axonics R20 and the Axonics F15 Systems used to deliver sacral neuromodulation (SNM) therapy. In clinical studies, Axonics Therapy has demonstrated meaningful improvement in patients’ quality of life in follow-up out to two years, with no serious device-related adverse events reported.
Flowonix Medical, NJ’s implantable infusion pump company
Image Credit: Flowonix Medical
Yesterday I was chatting with a friend regarding the medical device industry in NJ, and realized that I never posted a blog on Flowonix based in Mount Olive, NJ.
Flowonix was founded in 2005 (then called Medasys). It received approval to conduct its first clinical trial in 2007 on the Prometra programmable implantable pump. The company received approval by the FDA to market the Prometra in 2012 to deliver Infumorph.