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

Monthly Archives: January 2024

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).

FDA Approves Abbott’s Liberta RC DBS System

Posted on by Posted in Abbott, Brain Stimulation, Movement Disorders, Parkinson's Disease
Abbott Liberta RC DBS IPG

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

Posted on by Posted in AIMD Business, Brain Stimulation, Depression, Motif Neurotech
Motif brain stimulator for 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).”

 

In Memoriam: Dr. Bruce Wilkoff (1954-2024)

Posted on by Posted in News

I am deeply saddened by the news that Bruce Wilkoff, MD, a veteran cardiologist with Cleveland Clinic and a legend in the field of cardiovascular medicine, passed away on Sunday, Jan. 7. He was 69 years old.

I had the privilege of working with him when he consulted for Intermedics back in the 90s, and as late as last year (May 2023), when he and Prof. Niraj Varma were the first to implant the OPTIMIZER Integra CCM-D device developed by my team at Impulse Dynamics.

As I reflect upon his remarkable professional life, I can’t help but feel an overwhelming sense of gratitude. Dr. Wilkoff’s indelible impact on patients, physicians, and the CRMD Industry across the world will forever resonate.

To Dr. Wilkoff – You may have departed from this world, but your legacy will continue to inspire generations to come.

Nevro Announced 5% Workforce Layoffs As Part of Restructuring

Posted on by Posted in AIMD Business, Nevro, Pain, Spinal Cord Stimulation

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

Posted on by Posted in Brain Stimulation, Epilepsy, Essential Tremor, Medtronic, OCD, Parkinson's Disease
Medtronic Percept RC rechargeable DBS IPG www.implantable-device.com

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

Posted on by Posted in AIMD Business, Axonics, Boston Scientific, Incontinence, Sacral Root Stimulation

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

Posted on by Posted in Bradycardia, Cardiac Pacing, Medtronic
Medtronic's 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

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.

 

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.