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

Category Archives: AIMD Companies

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

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

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

 

Papers Supporting MR-Conditional IPG/Lead Mix-and-Match Presented at ISMRM 2021

Posted on by Posted in Impulse Dynamics, MRI-safe, My Portfolio

My colleagues and I presented yesterday two posters at the meeting of the International Society for Magnetic Resonance in Medicine (ISMRM).  In these papers we provide support for the idea that MR-conditional leads from one system can be matched with MR-conditional IPGs from a different system without compromising safety related to RF-induced heating .

D. Prutchi, J. Meyers, R. Shehada, RF Impedance of MR-Conditional Pacemaker Leads when Connected to Implantable Pulse Generators from Different MR-Conditional Systems, ISMRM 2021, Poster 1701_2281, Paper

In this paper,we demonstrate that at 63.87 MHz the RF impedance of IPGs is minimal relative to that of the leads, which dominates the overall impedance of the implantable system. Accordingly, mixed hybrid systems composed of MR-Conditional leads and any MR-Conditional IPG are expected to have a comparable overall impedance and consequently produce the same RF-induced heating as their corresponding original systems specified by the manufacturers.

J. Meyers, D. Prutchi, R. Shehada, Input Impedance Comparison of MR-Conditional Cardiac Implantable Pulse Generators at the 1.5T MR Frequency of 63.87 MHz, ISMRM 2021, Poster 2311, Paper

In this study, we measured the impedance at 63.87 MHz of several MR-conditional IPGs from different manufacturers to assess the role of the IPG in determining the RF-induced heating at the lead electrodes.  From the narrow impedance range measured, we suggest that the IPG component of an MR-Conditional system could be interchanged without compromising safety.

We also presented the following poster:

D. Prutchi, J. Meyers, R. Shehada, Importance of Pacemaker Lead Preconditioning for MR Safety In-Vitro Studies, ISMRM 2021, Poster 2282, Paper

In this study we investigated the change in the RF filtering characteristics of the leads of active implantable medical devices (AIMDs) as body fluids seep into the leads during the initial post implant period.  Our findings indicate that the RF characteristics change dramatically with fluid absorption, making it necessary to precondition the leads by soaking in isotonic saline solution to simulate the in-vivo scenario when conducting in-vitro MR safety testing. Furthermore, leads designed with RF-attenuating lumped inductances must consider the effect of fluid absorption on changing the peak RF attenuation frequency.

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.

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.

 

Boston Scientific’s Q1 2021 Results: CRM up 7.4%, Neuromodulation up 3.5%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific announced today its Q1 2021 results, showing CRM up 7.4% from $437M last year to $467M.  Neuromodulation also increased 3.5% from $191M last year to $198M.

Among its accomplishments related to AIMDs, it listed:

  • Launched Vercise Genus™ Deep Brain Stimulation (DBS) System in the U.S. Additionally, the system is being used with the world’s first 16-channel directional leads—Cartesia™ X and HX leads—in the eXTend 3D Study in Europe.
  • Commenced U.S. launch of the WaveWriter Alpha™ portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MR conditional, Bluetooth-enabled devices, new FAST paresthesia-free therapy and all supported by Cognita™ Solutions—a suite of digital tools that helps physicians and patients navigate the pain management journey.
  • Presented five-year outcomes from the EFFORTLESS study, the largest post-market registry of the Subcutaneous Implantable Defibrillator (S-ICD) System, further validating the long-term efficacy of the device. Results demonstrated 98% overall efficacy over five years, consistent with results of previous S-ICD studies and comparable to or higher than many large transvenous ICD studies.