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

Category Archives: Depression

Abbott starts clinical trial of DBS to treat depression

Posted on by Posted in Abbott, Brain Stimulation, Depression
Abbott St Jude Medical Infinity DBS IPG

Image Credit: Abbott

Back in 2022, the FDA granted Abbott Breakthrough Device designation for deep brain stimulation (DBS) for treatment-resistant depression (TRD), a form of major depressive disorder.  Now Abbott announced it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company’s DBS system to manage TRD.

Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.

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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).”

 

“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.

OT: My New Book on Near-IR Treatment of Brain Disorders is Now Available

Posted on by Posted in Alzheimer's, Brain Stimulation, David Prutchi's Portfolio, Dementia, Depression, Ischemic Stroke, My Portfolio, Opioid Overdose, Stroke

My new book is out and available through Amazon!

High-Power Near-Infrared Light Treatments for Depression, Dementia, and Other Brain Disorders

Light of specific wavelengths and intensities has been shown to repair and protect neurons from damage, opening the possibility of using near-infrared light as a non-invasive treatment of various brain and psychiatric disorders.

This book serves as a practical overview of the scientific fundamentals, technical implementation, and therapeutic applications of transcranial photobiomodulation:

  • Part I provides an accessible explanation of why the irradiation must be done in the near-infrared region of the light spectrum. It presents evidence-based background on the parameters of light important to photobiomodulation, and describes the effects of near-infrared light on cells and tissues.
  • Part II discusses the types of multi-Watt light sources required to non-invasively deliver therapeutic doses of infrared light to the brain. Importantly, this part describes in detail various High-Power Near-Infrared Transcranial Therapy (HIPNITT) medical devices that have been used in clinical trials.
  • Part III presents the potential and challenges of using near-infrared light in the treatment of various brain disorders such as depression, dementia, traumatic brain injury, and Parkinson’s disease.

This book uses straightforward language and offers practical guidance to help readers quickly develop an understanding of the practical aspects of HIPNITT implementation and its therapeutic applications.

Livanova and Verily Start Depression Sub-Substudy Using Symmetry VNS IPG and Verily’s Health-Tracking Devices

Posted on by Posted in Depression, LivaNova, Vagus Nerve Stimulation

Image Credit: LivaNova

LivaNova and Verily announced that they have enrolled their first patient in a study to evaluate treatment effectiveness for patients living with depression.  From the press release:

“The first patient has been enrolled in their collaborative UNCOVER study or “The RECOVER Sub-Study, Which Leverages Quantitative and Credible Research Tools from Verily, Will Provide Assessment Measures for Depressive Episodes.”

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The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD).

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Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device (Verily Study Watch) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living.

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Quantitative data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study, providing clinicians a more comprehensive view of whether each patient’s depression is improving, staying the same, or worsening.”

The Continuing CMS Coverage Saga of Cyberonics/LivaNova’s Vagus Nerve Stimulation for Treatment-Resistant Depression

Posted on by Posted in Cyberonics, Depression, LivaNova, Vagus Nerve Stimulation

LivaNova SenTiva VNS
Image Credit: LivaNova

Back in July, 2005, the FDA approved Cyberonics (now LivaNova) VNS implant for patients with chronic or recurrent depression, either unipolar or bipolar, with a history of failure of the depression to respond to at least four antidepressant interventions.

However, the U.S. Centers for Medicare & Medicaid Services (CMS) declined covering VNS for serious depression. CMS concluded back in 2007 that VNS’ effectiveness was not compelling enough to expand coverage, leaving drug-resistant epilepsy as its only covered indication.

Ten years later LivaNova presented data from a five-year study of VNS for treating TRD which showed that patients with chronic moderate to severe TRD experienced anti-depressant effects at a significant rate when treated with the therapy.

In response, last month (February 2019) CMS said:

“Based on the evidence, we believe that VNS for TRD seems promising but not convincing.” “To ensure benefits to Medicare beneficiaries we are proposing to cover VNS for the treatment of TRD when offered in double-blind, randomized, placebo-controlled studies.”

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Cerbomed’s Non-Invasive Vagus Nerve Stimulator Poses Challenge to Implantable VNS Systems

Posted on by Posted in Cerbomed, Cyberonics, Depression, Epilepsy, Inflammation, Pain, Vagus Nerve Stimulation

Cerbomed tVNS non invasive vagus nerve stimulator

Cerbomed GmbH, located in Erlangen, Germany, was founded in 2005 to develop transcutaneous Vagus Nerve Stimulation (t-VNS®) neuromodulation systems.

Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter t-VNS, which is delivered non-invasively to the auricular branch of the vagus nerve (ABVN), making it an attractive therapy option when compared to implantable vagus nerve stimulators.

The NEMOS tVNS system consists of a handheld stimulator and a dedicated ear electrode, which patients wear like an earphone.  According to Cerbomed, intensity, pulse duration and frequency of the t-VNS stimulation have been optimized to induce signals in thick-myelinated Aβ fibres of the ABVN. Like those of the cervical branch of the vagus nerve, these project directly to the nucleus of the solitary tract (NTS) in the brainstem.

In 2010 Cerbomed received the CE mark for its NEMOS® transcutaneous Vagus Nerve Stimulator for the treatment of epilepsy and depression. In 2012, the indication was expanded to include the treatment of pain.

In September 2012, Cerbomed entered into a strategic partnership with Cyberonics, Inc., the global market leader in vagus nerve stimulation.  Cyberonics made an initial investment of €2 million to fund Cerbomed’s epilepsy clinical trial in Germany, with further investments of up to €5.5 million, subject to the achievement of certain clinical milestones. Cyberonics is a minority shareholder with certain rights, including representation on Cerbomed’s advisory board and an exclusive option for worldwide sales and distribution of NEMOS.