Technologies for implantable devices
On November 24, 2021, EBR Systems went public in the Australian stock exchange. According to the press release, the IPO raised AU$110M (around $78.5M). EBR pland to use these funds to complete its pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial launch.
Image Credit: Parandromics
The scene has been hot for brain-computer interfacing (BCI) since Elon Musk announced its Neuralink project. One of Neuralink’s competitors is Austin-based Paradromics Inc., founded in 2015, about a year ahead of Neuralink. Bloomberg reported that Parandromics recently raised $20M to continue developing its high data rate implantable BCI.
Parandromics announced back in January 2020 that it had developed an implantable, low-power, high data rate neural sensor to enable massively parallel neural recordings for next-generation therapeutic applications. From the press release:
Image Credit: Neuspera Medical
Neuspera Medical is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that they closed a $65M series C equity financing round to fund their trial on the use of their device in patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder. The Series C round was co-led by Vertex Ventures HC and Treo Ventures.
Neuspera’s website: http://neuspera.com
FDA published yesterday a final guidance document which provides recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.
This new guidance supersedes FDA’s 2014 guidance “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.” The new guidance applies to all medical devices that might be used in the MR environment. This includes all implanted medical devices, medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter), medical devices that would reasonably be anticipated to enter the MR environment during clinical care, and all medical devices that are intended to enter the MR environment.
For active implantable medical device (AIMDs), the guidance makes reference to ISO/TS 10974 “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.”
Endotronix, a privately held company based in Illinois, recently announced that it had reached 100 implants of the Cordella™ Pulmonary Artery Pressure Sensor. These sensors provide heart pressure readings to the Cordella™ Heart Failure System to empower clinicians to proactively adjust therapy and medications remotely without the need for office visits.
According to the announcement:
“The Cordella System enables scalable remote heart failure management and aims to increase guideline directed medical therapy (GDMT) adherence and provide early detection of worsening heart failure. The platform consists of a comprehensive patient management system that securely collects non-invasive daily health data, coupled with a seamlessly integrated, next-generation implantable PA pressure sensor. Together, they deliver the necessary information for clinicians to proactively titrate medications and improve patient care between office visits while supporting reimbursement for care delivery activities.”
The Cordella PA implantable sensor is still an investigational device.
Endotronix website: endotronix.com
My colleagues and I presented yesterday two posters at the meeting of the International Society for Magnetic Resonance in Medicine (ISMRM). In these papers we provide support for the idea that MR-conditional leads from one system can be matched with MR-conditional IPGs from a different system without compromising safety related to RF-induced heating .
D. Prutchi, J. Meyers, R. Shehada, RF Impedance of MR-Conditional Pacemaker Leads when Connected to Implantable Pulse Generators from Different MR-Conditional Systems, ISMRM 2021, Poster 1701_2281, Paper
In this paper,we demonstrate that at 63.87 MHz the RF impedance of IPGs is minimal relative to that of the leads, which dominates the overall impedance of the implantable system. Accordingly, mixed hybrid systems composed of MR-Conditional leads and any MR-Conditional IPG are expected to have a comparable overall impedance and consequently produce the same RF-induced heating as their corresponding original systems specified by the manufacturers.
J. Meyers, D. Prutchi, R. Shehada, Input Impedance Comparison of MR-Conditional Cardiac Implantable Pulse Generators at the 1.5T MR Frequency of 63.87 MHz, ISMRM 2021, Poster 2311, Paper
In this study, we measured the impedance at 63.87 MHz of several MR-conditional IPGs from different manufacturers to assess the role of the IPG in determining the RF-induced heating at the lead electrodes. From the narrow impedance range measured, we suggest that the IPG component of an MR-Conditional system could be interchanged without compromising safety.
We also presented the following poster:
D. Prutchi, J. Meyers, R. Shehada, Importance of Pacemaker Lead Preconditioning for MR Safety In-Vitro Studies, ISMRM 2021, Poster 2282, Paper
In this study we investigated the change in the RF filtering characteristics of the leads of active implantable medical devices (AIMDs) as body fluids seep into the leads during the initial post implant period. Our findings indicate that the RF characteristics change dramatically with fluid absorption, making it necessary to precondition the leads by soaking in isotonic saline solution to simulate the in-vivo scenario when conducting in-vitro MR safety testing. Furthermore, leads designed with RF-attenuating lumped inductances must consider the effect of fluid absorption on changing the peak RF attenuation frequency.
Impulse Dynamics – the company for which I am CTO and Executive VP – announced today that it received European approval for labeling the OPTIMIZER Smart IPG as MR-Compliant for full-body MRI scans utilizing 1.5 Tesla scanners:
Impulse Dynamics – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.
From the press release:
IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA
Clears Potential Hurdle for Many Heart Failure Patients
MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.
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.”
Astellas today announced that it would acquire Iota in a deal that includes an initial payment of about $127.5M, covering the equity that Astellas did not acquire in 2018. An additional $176.5M are development-related milestone payments. Iota will be an independent subsidiary under Astellas’ U.S. umbrella.
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/
Image Credit: Neuspera Medical
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 December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that it had performed the first human implants as part of their SANS-UUI two-stage seamless pivotal clinical trial to support FDA approval for patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder.
Neuspera’s website: http://neuspera.com
Image Credit: Neuspera Medical
Image Credit: NeuroPace
NeuroPace of Mountain View, CA received FDA approval for MR-Conditional labeling of its RNS® implantable system for the treatment of medically refractory partial epilepsy.
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.
Ethylene oxide (EtO) is a chemical that is used to sterilize more than 50% of all medical device types and is crucial for preventing infection in patients undergoing surgeries and other medical treatments. For active implantable medical devices, EtO is pretty much the only option for sterilization. Alternative methods such as steam, radiation, or other sterilants either damage the device or do not achieve the needed levels of sterility assurance.
The US Environmental Protection Agency has been waging a war against the use of EtO by establishing an unreasonably low value for EtO concentration in its Integrated Risk Information System (IRIS). AdvaMed (the Advanced Medical Device Association) has urged the EPA to reassess its EtO value for one that is more feasible, based on the best available science and that will not potentially endanger the public health by threatening the availability of needed medical technologies.
AdvaMed President and CEO Scott Whitaker stated:
“… EPA’s EtO risk assessment standard is unworkable and not based on the best available science. The agency’s failure to address these valid scientific concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientific recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology.”
Click here to read AdvaMed’s complete response to the EPA.
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.
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.
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/