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

Category Archives: Treated Conditions

Implantable Devices to treat specific conditions

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.

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

Endotronix Reaches 100 Implants of the Cordella™ Pulmonary Artery Pressure Sensor

Posted on by Posted in Endotronix, Heart Failure (CHF), Sensors, Telemetry

Endotronix, a privately held company based in Illinois, recently announced that it had reached 100 implants of the Cordella™ Pulmonary Artery Pressure Sensor.  These sensors provide heart pressure readings to the Cordella™ Heart Failure System to empower clinicians to proactively adjust therapy and medications remotely without the need for office visits.

According to the announcement:

“The Cordella System enables scalable remote heart failure management and aims to increase guideline directed medical therapy (GDMT) adherence and provide early detection of worsening heart failure. The platform consists of a comprehensive patient management system that securely collects non-invasive daily health data, coupled with a seamlessly integrated, next-generation implantable PA pressure sensor. Together, they deliver the necessary information for clinicians to proactively titrate medications and improve patient care between office visits while supporting reimbursement for care delivery activities.”

The Cordella PA implantable sensor is still an investigational device.

Endotronix website: endotronix.com

 

Intermedics’ 1995 Res-Q ACD

Posted on by Posted in Cardioversion/Defibrillation, History, Intermedics (1974-1999), Museum, Tachycardia

In December of 1995 FDA approved the Res-Q ACD.  This was Intermedics’ first implantable defibrillator.  The abdominal-implant device was a relatively late-comer, and large for the time (230 g), but it did offer the highest energy output (40 Joules).  Another unique feature of the ResQ device was that it provided a connectorized sterile package which allowed complete pre-implant testing, thereby reducing the need for additional equipment.

Acknowledgement:  Thanks to Tim Carroll and Randy Armstrong at Velentium for allowing me to take a picture of this device in their collection.

Intec’s AID – The Very First Implantable Defibrillators

Posted on by Posted in Cardioversion/Defibrillation, History, Museum, Stephen Heilman, Tachycardia

Intec AID-B. (c) 2021 David Prutchi, PhD.

Conceived by physicians Michel Mirowski and Morton Mower, and supported by Dr. Stephen Heilman, the first automatic implantable defibrillator was developed and manufactured under the name of “AID” by Medrad/Intec Systems in Pittsburgh, PA.

It was encased in titanium and hermetically sealed with a laser beam weld. It had a volume of 145 ml and weighed 250 gm. The device was powered by lithium batteries which had a projected monitoring life of 3 years or a discharge capability of 100 shocks.

The ICD was designed to detect ventricular fibrillation and sinusoidal ventricular tachycardia, and it attempted to using a truncated exponential 25 Joules pulse.  The device could recycle three times during a single episode with the third and fourth pulses delivered at 30 Joules.

The device was meant to be connected to electrodes made from titanium and coated with silicone rubber. One defibrillating electrode was located intravascularly in the superior vena cava (SVC) at the right atrial junction. The second electrode had the configuration of a rectangular patch or a cup and was positioned over the cardiac apex.

First implants of the device were conducted at the Johns Hopkins Hospital in Baltimore in 1980.  These devices were not programmable and manufactured on an individual basis.  The AID was then improved with rate-counting circuitry and could synchronize shocks with the R-wave.  Efforts were also made to reduce the recycling time after a failed shock.  The new device was called the AID-B (shown in the picture), but was still manufactured according to individual specifications.

Circuitry of the AID-B implantable defibrillator. From: PJ Troup, “Implantable Cardioverters and Defibrillators”, Current Problems in Cardiology, Volume 14, Issue 12, December 1989.

Acknowledgement:  Thanks to Tim Carroll and Randy Armstrong at Velentium for allowing me to take a picture of this device in their collection.

NeuroPace IPO

Posted on by Posted in AIMD Business, Brain Stimulation, Epilepsy, NeuroPace

Image Credit: NeuroPace

NeuroPace of Mountain View, CA  announced last month that it filed with the SEC to raise up to $75 million in an initial public offering. However, the IPO was upsized from the initial expectations, with the company offering 6 million shares of common stock at $17 per share, totaling gross proceeds of $102 million.  It shares began trading on April 21, 2021 on the Nasdaq under the NPCE ticker.

On April 26 NeuroPace announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at the initial public offering price of $17.00 per share. The gross proceeds to NeuroPace, before deducting underwriting discounts and commissions and offering expenses, were approximately $117.3 million.

Shares rose above $24 after the first day of trading, and have remained steady, closing at $25.78 today.

Unlike Cyberonics’ VNS IPGs, the RNS® neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.

 

Zoll Medical Acquires Sleep Apnea Treatment Company Respicardia

Posted on by Posted in Central Sleep Apnea, Neural Stimulation, Respicardia, Zoll

Image Credit: Respicardia

Zoll Medical announced on April 12, 2021 that it had acquired Respicardia and its neurostimulation technology for treating sleep apnea.  The financial terms of the deal were not disclosed.

Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function.

Zoll Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions for emergency care, and has been a significant Respicardia investor.

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.”

…

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).

…

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.

…

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.”

Historical Piece: Intermedics’ C-MOS-I Mercury-Cell Pacemaker (1973)

Posted on by Posted in Bradycardia, Cardiac Pacing, Intermedics (1974-1999), Museum

Intermedics C-MOS-I Pacemaker. Image credit: Michael Sklanowsky

In 1973, former Medtronic sales representative Albert Beutel founded Intermedics in Freeport, TX. The company’s first product was the C-MOS-I implantable pulse generator – a small (for the time), mercury-cell-powered pacemaker.

Mike Sklanowsky shared pictures of a C-MOS-I sample that he owns.  Mike was a software consultant to Intermedics in Freeport around 1974, where he developed the first computerized pacemaker tracking and product recall software.  Through his software, Intermedics tracked pacemaker  locations and movement through distribution warehouse shelves, hospitals, clinics, doctors, nurses, patient notification of expiring battery charge, product recall communications, follow-ups, etc.

Before Intermedics, Mike worked for JPL, which was his first full-time job upon graduating from UCLA.  At JPL he worked on problems related to celestial mechanics, spacecraft orbit determination, trajectory analysis, instrument operations, and human interfaces for real-time command and control.  His first project was Mariner 9 Mars, which became the first man-made satellite to orbit another planet.

Mike, and fellow UCLA graduate Bob Patterson were the only two people from their class to get hired by JPL.  Bob’s mentor, Prof. Ken Nobe involved both with Intermedics.  Dr. Robert (Bob) Patterson was an expert in long-life lithium battery technology for space exploration, and his work for Intermedics led to the 1974 development of a lithium-powered version of C-MOS-I, followed in 1976 by InterLith which was hermetically sealed, and weighed just 65 grams.

Berlin Heals Publishes Results of First-In-Human C-MIC Study

Posted on by Posted in Berlin Heals, Cardiac Stimulation (other), Heart Failure (CHF), Microcurrent
Berlin Heals C-MIC

C-MIC Device. Image Credit: Berlin Heals

Berlin Heals just published the results of its first-in-human study of its C-MIC device, which was conducted in 10 NYHA Class III heart failure patients with LVEF<35%.  The C-MIC is an implantable electroceutical device intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients.

In the study follow‐ups, a rapid and significant signal of efficacy (P < 0.005) was present with improvements in LVEF, left ventricular end‐diastolic diameter, left ventricular end‐systolic diameter, and distance walked. For eight patients, NYHA classification improved from Class III to Class I (for seven, as early as 14 days post‐operatively); for one, to Class II; and for one, to Class II/III. 36‐Item Short‐Form Health Survey questionnaire scores also improved highly significantly.

Berlin Heals has now initiated a randomized, controlled trial in 100 DCM patients, which will take place in Germany, Austria, Serbia, and Poland.

In addition, the FDA has granted Breakthrough Device designation for the C-MIC system

Berlin Heals website: http://berlinheals.de/

Corvion’s Fully Implanted Left Ventricular Assist Device

Posted on by Posted in AIMD Companies, Circulatory Support, Corvion, EverHeart, Heart Failure (CHF)

Image Credit: Corvion

Corvion is a pre-clinical stage company based in Webster, Texas.  They are developing a fully-implantable LVAD that incorporates a highly efficient implantable rotary blood pump (Corvion claims 3X more efficient than competitors) coupled with a thin battery that gives 3 hours of free operation, and a robust transcutaneous energy transmission system.

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