The First Workshop on Active Implantable Medical Devices took place at in Punta del Este, Uruguay last Friday (March 1st 2024) as part of the LASCAS 2024 meeting.
Category Archives: AIMD Companies
The CARSS OpenNerve Device: An Open-Source Neuromodulation System for Autonomic Nerves
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
Taiwan’s Gimer Medical 500 kHz NeuroBlock SCS
Image Credit: Gimer Medical
Gimer Medical is a Taiwanese medical device manufacturer founded in 2013. It set up the first implantable electronics factory in Taiwan in 2018.
Gimer’s NeuroBlock spinal cord stimulation (SCS) system is based on technology developed at the Taiwan National University in 2008 combining pulsed radio frequency (PRF) with SCS into the so-called “+RF” technology – an ultra-high frequency of 500 kHz, which Gimer claims has a high penetration rate, no heat sensation during the treatment, no protein denature, and no action potential changes. It is expected to produce paresthesia-free and prolonged treatment effect for chronic pain patients.
On August 13, 2022, the US FDA granted conditional Investigational Device Exemption (IDE) approval to Gimer to trial the NeuroBlock SCS system.
Impulse Dynamics Completes $136M Financing Round
Impulse Dynamics, the company where I’m CTO and Executive VP, announced yesterday that it completed a $136M financing round to accelerate its commercial growth and advancing the development of pipeline products.
From the announcement:
“Marlton, NJ, Feb. 14, 2024 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it raised $136 million in financing to accelerate investment in global commercialization, technology, product innovation, and further development of clinical evidence. The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare. This substantial investment reflects investor confidence in, and commitment to, the company’s vision and expansion.
…
The funding will fuel commercialization efforts, develop future product pipelines, and support groundbreaking clinical trials such as the INTEGRA-D and AIM HIGHer clinical trials. The INTEGRA-D trial is a multicenter study evaluating the combination of CCM and ICD therapy in a single device – the Optimizer Integra CCM-D System. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM therapy in patients with symptomatic HF with an ejection fraction (EF) of 40 to 60 percent (inclusive). The trial is currently in its initial enrollment phase and has generated significant attention, feedback, and excitement among experts in HF.”
UroMems’ UroActive Implant for Stress Urinary Incontinence
Image Credit: UroMems
UroMems was founded in 2011 in Grenoble, France. They are developing the UroActive™ implantable device to treat Stress Urinary Incontinence (SUI), or involuntary urinary leakage, which affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the sphincter around the urethra.
The “MyoElectroMechanical System (MEMS)” is placed around the urethral duct and is designed to be automatically controlled based on the patient’s activity, without the need for manual adjustments.
According to UroMems, “The expected benefit of the UroActive™ device is twofold. First, the urethral pressure can be increased when the patient is engaged in a physically demanding activity, which is expected to improve continence during activity. Second, when the patient’s activities do not require increased pressure, the compression on the urethral tissue can be released, therefore potentially reducing erosion or other tissue damage.”
The first human implant of the device was performed in November of 2022, and a 6 male subject feasibility study reached its six-month endpoint last December. The Company announced today that its first female patient had reached the six-month endpoint.
BCI Developer Synchron Acquires Equity Stake in Nitinol Part Maker ACQUANDAS
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
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).
FDA Approves Abbott’s Liberta RC DBS System
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”
Motif Neurotech Raises $18.75M to Fund R&D and Clinical Study of Device to Treat Depression
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).”
Nevro Announced 5% Workforce Layoffs As Part of Restructuring
Image Credit: Nevro
As part of its Q4 2023 results, Nevro announced that it plans to lay off approximately 5% of its internally-facing workforce to increase its 2024 earnings by $14 million to $15 million.
This news comes after Nevro announced at the end of November 2023 that it acquired Vyrsa Technologies for $40 million cash plus up to an additional $35 million based on milestones. Vyrsa manufactures a spinal-fusion device for patients suffering from chronic sacroiliac joint (“SI Joint”) pain.
Nevro’s Q4 2023 worldwide $116.0 million revenue exceeded Company’s expectations (2% growth as reported and 1% constant currency compared with Q4 2022). Its full-year 2023 worldwide revenue was approximately $425.0 million, representing 5% growth reported and 4.5% on a constant currency basis.
FDA Approved Medtronic’s Percept™ RC Rechargeable DBS IPG
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.”
Boston Scientific Acquires Axonics
Image Credit: Axonix
Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Axonics, a company that develops implantable sacral neuromodulation devices to treat urinary and bowel dysfunction. According to the announcement, the purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion.
Medtronic Receives CE Mark for its Micra AV2 and VR2 Leadless Pacemakers
Image Credit: Medtronic
Medtronic announced that it received CE mark approval for its next-generation Micra AV2 and Micra VR2 leadless pacemakers.
According to the press release:
“Micra AV2 and Micra VR2, the world’s smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.
With approximately 40% more battery life compared to previous generations, Medtronic projects the battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively. This means more than 80% of patients who receive a Micra may only require one device for life.
This CE Mark milestone follows U.S. Food and Drug Administration approval for the Micra AV2 and VR2 devices in 2023.
In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient’s heart device without the need for a patient to travel to their clinic for an in-person appointment. Other patient benefits of remote monitoring may include a reduction in hospitalizations and increase in sense of security.”
Endotronix Submits PMA Application for the Cordella PA Sensor
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.
Lepu Medical Granted Chinese “Green Channel” for Implantable Cardiac Contractility Modulator (ICCM)
Image Credit: Lepu Medical Technology (Beijing) Co., Ltd.
Chinese Lepu Medical Technology (Beijing) Co., Ltd. announced on LinkedIn on January 5, 2024 that it had been granted “Green Channel” review status by the NMPA for its Implantable Cardiac Contractility Modulator (ICCM).
According to the LinkedIn post, the device to be reviewed by the Chinese NMPA is “an implantable pulse generator that utilizes cardiac contractility modulation therapy to treat symptoms in patients with heart failure. This product is suitable for adult patients with New York Heart Association (NYHA) functional class III or IV heart failure, aiming to improve the patients’ 6-minute walking distance, quality of life, and cardiac functional status.”
Despite Lepu’s claim in the post that “the adoption of cardiac contractility modulation therapy is the first of its kind in China,” in fact, Cardiac Contractility Modulation was pioneered by Impulse Dynamics which has had commercial approval in China for its OPTIMIZER CCM™ devices since 2017.