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

Author Archives: David Prutchi

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.”

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.

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.

 

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.

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.

Continue reading→

Onward’s SCS systems for Improving Function after Spinal Cord Injury

Posted on by Posted in Onward, Spinal Cord Injury (SCI), Spinal Cord Stimulation

Image credit: Onward

Onward is a company dedicated to the development of spinal cord stimulation therapies to improve function after spinal cord injury.  Onward was formed in 2014 by researchers at the Swiss Federal Institute of Technology (EPFL). They are now headquartered at the High Tech Campus in Eindhoven, the Netherlands and the EPFL Innovation Park in Lausanne, Switzerland. Onward also has a growing team based in Boston, MA.

Medgadget carried today an interesting interview with Onward’s CEO regarding their technology (the ARC devices).

Onward’s website: onwd.com

 

Second Sight and Pixium Vision Combine Businesses

Posted on by Posted in AIMD Business, Blindness, Brain Stimulation, Pixium Vision, Retinal Stimulation, Second Sight

Back in March of 2020, Second Sight Medical announced that it was winding down its operations.  Second Sight developed implantable devices intended to create an artificial form of useful vision for blind individuals.  However, because of the impact of COVID-19 on its ability to secure financing, it laid off the majority of its employees as a first step to an orderly wind-down of its operations.

The company had developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain. At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients. Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.

On January 6, 2021, Second Sight and France’s Pixium Vision announced that they have entered into a definitive business combination agreement pursuant to which Pixium Vision will, following the contribution to Second Sight of all of its assets and liabilities in relation to its neuromodulation technology used in the treatment of blindness, become the controlling shareholder of the new combined company, owning 60% of the total equity before the capital raise. The combined company will focus on retinal stimulation through Pixium’s Prima System.  As part of the transaction, a new subsidiary will be created to focus on cortical stimulation through Orion. The new combined company will own 40% of the new subsidiary and will also have a first option to exclusive global marketing rights for Orion.

Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision