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

FDA Approves Respicardia’s Remede EL-X System for Central Sleep Apnea

Posted on by Posted in Central Sleep Apnea, Respicardia

Image Credit: Respicardia

FDA has approved Respicardia’s  remedē® EL-X System to treat moderate to severe Central Sleep Apnea (CSA) in adult patients. The device combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. According to Respicardia, features of the new device include:

  • Extended longevity: 40% longer average battery life versus previous version
  • Reduced size: Approximately 25% smaller than the previous version
  • Simplified implant: Single lead, single-port system that provides both stimulation and sensing from a single lead
  • Data-driven clinical insights with DRēAM View. Enhancements include full-night, comprehensive diagnostic capabilities

Boston Scientific Recalls 48,000 Ingenio Pacemakers

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Heart Failure (CHF)

Boston Scientific has recalled approximately 48,000 Ingenio pacemakers and cardiac resynchronization devices distributed between November 2011 and August 2020.  The potentially defective devices, which were manufactured only through December 2018, are no longer available for implant. The recall was initiated on June 3, 2021, and now FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death.

The issue is that after several years of use, the batteries  reach a high level of internal impedance. At that point, a sudden decrease in battery voltage may occur during telemetry, incorrectly triggering a system reset. If the system resets three times within 48 hours, it’s sent into safety mode.  However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, the device cannot be reprogrammed and must be replaced.

According to FDA, the use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death.

Parandromics Raises $20M to Develop High Data Rate BCI

Posted on by Posted in AIMD Business, Brain-Computer Interface, EEG Monitoring, Paralysis, Parandromics

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:

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Nalu Externally-Powered Neurostimulation System for SCS and PNS Indications

Posted on by Posted in Nalu, Pain, PNS, Spinal Cord Stimulation

Image Credit: Nalu

Nalu Medical, Inc. is a privately held, early-stage start-up based in Carlsbad, California.  They developed the Nalu micro-Implantable Pulse Generator (mIPG), which was was named the Implant and Tissue-Replacement device Gold Winner at the 2021 Medical Design Excellence Awards (MDEA).

The Nalu system consists of a fully-featured, battery-free, miniaturized IPG, which is powered by an externally worn Therapy Disc and controlled through a smartphone based remote control app. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications.

Nalu’s website is at: nalumed.com

Neuspera Medical Closes $65M Round to Fund Urinary Urgency Incontinence Trial

Posted on by Posted in AIMD Business, Incontinence, Neuspera, Neuspera Mid Field Powering, Sacral Root Stimulation

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

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.

Nevro Receives FDA Approval for for High-Frequency SCS Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)

Posted on by Posted in AIMD Business, Nevro, Pain, Spinal Cord Stimulation
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain

Image Source: Nevro’s Website

FDA has approved an additional indication of Nevro’s Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN).  According to the announcement, “this approval is specific to Nevro’s unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN.  The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.”

Nevro also announced its Q1 2021 revenue to be around $102.3 million, an increase of 81% compared to $56.4 million in the prior year period and an increase of 9% compared to $93.6 million in the second quarter of 2019.  Nevro expects Q2 2021 revenue to be $85.0 million, an increase of 67% compared to $51.0 million in the prior year period and an increase of 9% compared to $78.1 in the second quarter of 2019.

Merck and Spain’s INBRAIN Neuroelectronics to Collaborate in Development of Graphene-Based Vagus Nerve Stimulators

Posted on by Posted in INBRAIN, Inflammation, Merck, Rheumathoid Arthritis, Vagus Nerve Stimulation

INBRAIN Neuroelectronics S.L. was funded in Barcelona, Spain in 2019 as a spin-off from Graphene Flagship partners, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) and ICREA. Its subsidiary INNERVIA Bioelectronics is working towards the development and commercialization of graphene-based systems to modulate vagus nerve signals.

INBRAIN announced that it will be collaborating with Merck to co-develop the next generation of graphene bioelectronic vagus nerve therapies targeting severe chronic diseases in Merck’s therapeutic areas.

INBRAIN’s website is at:  www.inbrain-neuroelectronics.com

 

Abbott’s St Jude Medical to Pay $27 Million to Settle DOJ Claims they Knowingly Sold Defective ICDs

Posted on by Posted in Abbott, Cardioversion/Defibrillation, Heart Failure (CHF), St. Jude Medical, Tachycardia

In October 2016, St. Jude Medical (now Abbott) issued an advisory on a family of ICD and CRT-D devices that may develop Lithium deposits within the battery leading to a short circuit and result in premature and potentially rapid battery depletion.  However, according to the DOJ, St. Jude was already aware of the issue by 2013.   In 2014 St Jude asked the FDA to approve an update to the devices to mitigate the battery issue. In its request, St. Jude claimed that the issue had not caused any serious injuries or deaths, but the DOJ claimed that the company had been informed of two injuries and one death caused by the issue.

The lawsuit covers the period between November 2014 and October 2016, during which the DOJ claims St. Jude was fully aware of the device’s issues but continued selling thousands of devices.  By August 2016, St. Jude reported to FDA two more deaths linked to this issue, and over 700 cases of premature battery depletion.

The federal case was brought under the False Claims Act based on the allegation that by continuing to sell the potentially harmful products to healthcare facilities and implanted in patients enrolled in Medicare and Medicaid, St. Jude played a role in securing government payments for devices that they knew were defective. It was announced on July 8, 2021 that St. Jude Medical agreed to pay $27 million to settle this case.

 

CVRx Files Intention to IPO with SEC

Posted on by Posted in AIMD Business, Baroreceptor Stimulation, CVRx, Heart Failure (CHF)

Image Credit: CVRx

Back in August of 2019, Minneapolis-based CVRx received a no-panel FDA approval for its BAROSTIM NEO™ device to treat Heart Failure.  CVRx has now filed documents with the SEC with plans to offer 6.25 million shares of common stock priced between $15 and $17 per share, expecting to yield approximately $91.5 million in the offering.

The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors.  The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

CVRx’s system  is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.

CVRx website:  www.cvrx.com

UPDATE: June 30, 2021, 2:49 pm

Yesterday CVRx upsized its IPO of 7M shares of its common stock at a public offering price of $18 per share.  Trading started today and share price was $27 mid-afternoon.

UPDATE: July 9, 2021, 2:09 pm

A week after IPO CVRx’s stock has lost all of its initial gains.  It is now trading around the original offering price of $18.

 

 

Update December 13, 2021

And CVRx stock keeps on tanking…

Medtronic Stops Sale of HeartWare HVAD™ System After Multiple Class-I Recalls

Posted on by Posted in Circulatory Support, Heart Failure (CHF), Medtronic

Medtronic announced that it will stop the distribution and sale of HeartWare’s HVAD™ System.

According to the announcement:

“Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.”

The device has been the subject of multiple Class I recalls because of reports of 91 injuries and 15 deaths. FDA advised healthcare providers to stop new implants of the HeartWare system, stating that Medtronic has “received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary.”

FDA has advised providers to use Abbott’s HeartMate 3 Left Ventricular Assist System as an alternative.

Tesla LSK 200 Pacemaker, Czechoslovakia 1969

Posted on by Posted in Cardiac Pacing, History, Museum, Tesla Czechoslovakia

In the late 1960s and early 1970s, Czechoslovakia, like many other countries, had its own pacemaker development/manufacturing.

Starting in 1965, Dr. Bohumil Peleška and ing. Vladimír Bičík designed and manufactured a VOO pacemaker under the auspices of the “Research Institute for Medical Electronics and Modelling” (RIMEM).  The device underwent human implantation and worked for 2 years before being preemptively replaced.

RIMEM’s pacemakers were then transferred for commercial production at the Czechoslovak TESLA state-owned electrotechnical conglomerate.  TESLA was originally named after Nikola Tesla, but later explained by the Communist regime as an abbreviation from TEchnika SLAboproudá, which means “low-voltage technology.”

An interesting presentation about the history of pacemakers in the former Czechoslovakia is available here.

Bivacor Raises $22M to Start Human Trials of its Total Artificial Heart

Posted on by Posted in AIMD Business, Bivacor, Circulatory Support, Heart Failure (CHF)

Image Credit: Bivacor

Houston-based Bivacor, which was founded in 2008, has raised a total of $22M through a $19M series B funding round (co-led by Cormorant Asset Management and OneVentures) and a $3M NIH small-business grant from the National Heart, Lung and Blood Institute.  This money will be used to continue testing Bivacor’s Total Artificial Heart and expand the company’s workforce, as it prepares to begin its first human trials.

The device is unique in that it features a single moving part.  Two centrifugal impellers placed on a single rotor provide perfusion to the left and right sides of the body.  According to the company, active magnetic levitation provides precise, stable operation with no mechanical wear, while the device’s patented left-right flow-balancing system allows dynamic adaptation to changes in the patient’s physiology.

The centrifugal pump is powered by an external battery and controller connected via a transcutaneous cable. According to Bivacor, the device is small enough for a child but also powerful enough for a physically active adult.

Bivacor website: www.bivacor.com

FDA Publishes Guidance on Testing and Labeling Medical Devices for MRI Safety

Posted on by Posted in AIMD Business, MRI-safe

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.”