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

Category Archives: Therapies

AIMDs classified according to general type of therapy

Lepu Medical Granted Chinese “Green Channel” for Implantable Cardiac Contractility Modulator (ICCM)

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, Lepu Medical

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.

 

ShiraTronics conducting clinical trial of its system intended to treat migraine

Posted on by Posted in Migraine, Neural Stimulation, Occipital Nerve Stimulation, ShiraTronics
ShiraTronics Implantable device for the treatment of migraine

Image Credit: ShiraTronics

Broolin Park (MN)-based ShiraTronics is currently conducting a clinical trial in Australia of its implantable system intended for the prophylactic treatment of refractory chronic migraine.

The ShiraTronics System is intended to provide electrical stimulation to nerves associated with migraine pain. The therapy includes a temporary Trial System and a permanent Implant System. The Trial System components include percutaneous leads temporarily placed in the supraorbital and occipital regions. The Implant System components include rechargeable IPGs with integrated leads. The IPGs are implanted in subcutaneous pockets posteriorly on the head with leads tunneled to the supraorbital and occipital regions. Both systems are controlled by a programmer with a therapy application.

The system is approved for clinical trial use only in Australia.  ShiraTronics expects to conclude the study started in August 2023 late this year or early next year.

ShiraTronics System for the treatment of migraine

Image Credit: ShiraTronics

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.”

Medtronic receives FDA approval for Aurora EV-ICD™

Posted on by Posted in Cardioversion/Defibrillation, Medtronic, Tachycardia
Aurora EV-ICD™

Image Credit: Medtronic

Medtronic announced today that it received FDA approval for its Aurora EV-ICD™ MRI SureScan™ Extravascular Implantable Cardioverter-Defibrillator and Epsila EV™ MRI SureScan™ defibrillation lead.

According to the press release:

“The Aurora EV-ICD system is the first-of-its-kind to provide the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs.”

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Amber Therapeutics Acquires Bioinduction for its Picostim DyNeuMo

Posted on by Posted in Amber Therapeutics, Incontinence, Neural Stimulation, Pudendal Nerve Stimulation
Picostim DyNeuMo

Image Credit: Zamora et al https://doi.org/10.1101/2020.09.10.292284

Amber Therapeutics has acquired  fellow U.K.-based Bioinduction, a for its Picostim DyNeuMo platform.  The implantable device was originally designed as a deep-brain stimulation device for the treatment of Parkinson’s disease.  However, Amber intends to utilize it first as a pudendal nerve stimulator for treating mixed urinary incontinence, where patients experience symptoms of both stress and urge incontinence.

The device is currently being trialed in Belgium as part of a 15 female subject pilot study to evaluate its safety and efficacy.

“Pea-Sized” Brain Stimulator Being Developed by Motif for Treating Depression

Posted on by Posted in Brain Stimulation, Depression, Motif Neurotech
Motif brain stimulator for depression

Image Credit: Motif Neurotech

Motif Neurotech, based in Houston, TX is developing a “pea-sized” implantable brain stimulator intended for the treatment of depression.

An interesting preprint was published by Motif’s engineers in collaboration with researchers at Rice University, Baylor College of Medicine, and UTHealth Houston on their millimeter-sized battery-free epidural cortical stimulators.  The paper discusses the engineering of the implant, a 30-day porcine study, as well as an intra-operative human test of the device.

Motif’s concept is to implant the device through a simple outpatient procedure, and having the patient periodically wear at home a headset that transmits power to the implant to deliver episodic neuromodulation.

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.”

 

 

Precis Receives CE Mark for EASEE® System for Treating Refractory Focal Epilepsy (Sep 2022)

Posted on by Posted in Epilepsy, Neural Stimulation, Precis GmbH
Precis Easee System for treating epilepsy

Image Credit: Precis

Precis GmbH is a German company headquartered in Heidelberg developing neuromodulation systems.  On September 15, 2022, Precis received the CE Mark for its EASEE® system  for treating adults with therapy-refractory focal epilepsies.

The EASEE® implant consists of a thin electrode pad that is implanted under the skin of the scalp and an IPG that is is implanted in the chest area and connected to the electrode pad with a cable.

Precis’ electrode design is claimed to produce deep and focused stimulation of the brain.  According to Precis’ website:

“A so-called Laplace electrode generates fields and current flows perpendicular to the electrode pad. In the EASEE® System, the external ring-shaped electrode is replaced by four individual electrodes in order to adapt the direction of the resultant electrical field to spatially varying resistances. In this way, significant current flows can be achieved on the surface of the brain as well as a penetration depth comparable to that of more invasive procedures.”

JAMA Neurology published a paper on April 4, 2023 detailing clinical results with the EASEE® System.  After six months’ active treatment, 53% of patients demonstrated a full response to the device, as defined by a reduction in seizure frequency of at least 50% below baseline. 84% of patients demonstrated a response of some kind. There were no serious events reported which were related to either the device or its implantation. A summary is available here.

AngelMed Changes Name to Avertix, Prepares to Go Public Through SPAC

Posted on by Posted in Acute Coronary Syndrome, AIMD Business, Angel Medical, Avertix, ECG Monitoring

Image Credit: Angel Medical Systems

In May 2023 AngelMed changed its name to Avertix.  AngelMed developed the Guardian System, which is an FDA-approved implantable device designed to detect and warn patients of acute thrombotic coronary occlusion.

BIOS Acquisition Corporation, a special purpose acquisition company, then announced that it had entered into a definitive merger agreement with Avertix so it would become a publicly traded company on Nasdaq. The Transaction is expected to close in the second half of 2023.  According to the announcement, the combined company, which will be named Avertix Medical, Inc., will have an enterprise value of approximately $195 million.

Biotronik Receives FDA Approval for Prospera SCS System (March 2023)

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera SCS

Image Credit: Biotronik (from FDA’s PMA approval)

Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System on March 31, 2023.  The system is intended to treat chronic, intractable pain in the trunk or limbs.

The Prospera SCS System includes a rechargeable IPG, SCS leads, a clinician programmer, a patient programmer, and an external trial pulse generator.

The system features connectivity with Biotronik’s Embrace One™, which the company claims to provide automatic, objective, remote daily data transmission for true proactive care management.

Chinese Pacemakers by Qinming Originated in Delaware

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardio-Pace, History, Qinming Medical
Pacemakers by Qingming (China)

Image Credit: Qingming

Cardio-Pace Medical, Inc was incorporated in Delaware on April 20, 1981 to develop, manufacture, and market its proprietary Durapulse(TM) cardiac pacemaker and accessory products. Although Cardio-Pace achieved sales of its pacemakers, it did not achieve profitability.  As a result, they suspended manufacturing the cardiac pacemaker in 1990. During 1985, Cardio-Pace entered into an agreement with Qinling Semiconductor to establish Qinming Medical, Inc., a Sino-American joint venture in Baoji, China, for the manufacture and distribution of cardiac pacemakers and accessory products. In 1992, Cardio-Pace sold its 49% interest in the joint venture to Qinming.

In 2010, Lepu Medical of Beijing purchased a 30.46 percent stake in Qinming as part of its efforts to forge an integrated Chinese cardiovascular products company. In 2013, Lepu completed the acquisition of Shaanxi Qinming Medical Instruments Co., Ltd.

Around that time, Qinming developed the QM7211, which was the first domestically developed dual-chamber rate-responsive pacemaker in China.  Its clinical study to evaluate it for non-inferiority against a Biotronik Talos pacemaker was successfully completed in 2015.

Today, Qinming is Lepu’s subsidiary in charge of the development, manufacture, and marketing of pacemaker products.  Their line includes single- and dual-chamber devices, as well as passive and active-fixation leads.

 

China’s Singular Medical Completes Domestic ICD Trial

Posted on by Posted in Cardioversion/Defibrillation, Singular Medical, Tachycardia
Singular Medical's products

Image Credit: Singular Medical

Singular Medical  was founded in 2017 and is headquartered in Suzhou, China.  They have development offices in Beijing, Irvine CA,  and Minneapolis MN.

In May 2023 they completed the first Chinese human clinical trial on a domestic ICD, which puts them on their way to marketing their single-chamber, DF-4 ICD.  According to their website, the device offers tiered therapy and Bluetooth-based telemetry, and the programmer is an Android-based tablet PC.    The website also shows an active-fixation DF-4 single-coil lead, as well as an ILR.

 

Orchestra Biomedical Receives Approval to Start BACKBEAT IDE

Posted on by Posted in BackBeat Medical, Bradycardia, Cardiac Pacing, Hypertension, Medtronic, Orchestra Biomedical
Orchestra Biomed Backbeat therapy for hypertension in patients indicated for dual-chamber pacing

Image Credit: Orchestra BioMed

Orchestra Biomedical announced that it has received FDA’s approval (Sep 19, 2023) to initiate its BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) IDE study for evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™) for treating hypertensive patients who are indicated for a dual-chamber cardiac pacemaker.

Orchestra and Medtronic formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population.

Insulation Separation in Glassed Feedthrough Behind Class-I Recall of 348k Medtronic ICDs

Posted on by Posted in Cardioversion/Defibrillation, Medtronic, Tachycardia

On July 18, 2023 Medtronic recalled approximately 384,000 ICD and CRT-D devices due to increased potential for a reduced- or no-energy HV therapy.

The devices, manufactured after July 17 have a glassed feedthrough, and its insulating layers may separate.  When this happens, an unintended current pathway forms within the void created by the insulation separation, capable of conducting high levels of current during HV therapy.  The low-energy output issue is most likely to appear when the device is programmed to deliver therapy in the AX>B pathway.

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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.