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

Category Archives: MRI-safe

Synergia Medical’s NAO·VNS™ Optoelectronic Neurostimulator

Posted on by Posted in Biophan, Epilepsy, MRI-safe, Photovoltaic, Synergia Medical, Vagus Nerve Stimulation
Synergia NAO.VNS optoelectronic stimulator for epilepsy

Image Credit: Synergia Medical

Synergia Medical is a Belgian company founded in 2014 developing a neurostimulation system that powers the stimulation electrodes by photovoltaic conversion of light pulses produced by a generator connected via optical fiber.

The concept is to reduce major metallic components such that the device can be operated while the patient undergoes a functional MRI (fMRI), and hence, according to Synergia, allow the device’s performance to be assessed and optimized at the time of implant. Continue reading→

Impulse Dynamics receives full-body MRI-conditional approval for OPTIMIZER Smart Mini System

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

OPTIMIZER Smart Mini whole-body MRI

Impulse Dynamics, the company for which I am the CTO, announced that FDA has approved full-body MRI-conditional labeling for the OPTIMIZER Smart Mini IPG.  According to the announcement:

“The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.”

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.”

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.

FDA/CE MR-Conditional Approvals for Impulse Dynamics’ OPTIMIZER Smart IPG

Posted on by Posted in Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

Impulse Dynamics – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.

From the press release:

IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA

Clears Potential Hurdle for Many Heart Failure Patients

MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.

Continue reading→

FDA Approves MRI-Conditional Labeling for NeuroPace’s RNS System for Treating Epilepsy

Posted on by Posted in Brain Stimulation, EEG Monitoring, Epilepsy, MRI-safe, NeuroPace

Image Credit: NeuroPace

NeuroPace of Mountain View, CA received FDA approval for MR-Conditional labeling of its RNS® implantable system for the treatment of medically refractory partial epilepsy.

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.

Continue reading→

FDA Accepts Zurich MedTech’s IMAnalytics and Field Exposure Libraries as a Medical Device Development Tool

Posted on by Posted in MRI-safe, Tech Talk

Image Credit: Zurich MedTech

The FDA announced the acceptance of Zurich MedTech’s Sim4Life IMAnalytics and the field exposure libraries MRIxVIP1.5T and MRIxViP3.0T from the IT’IS Foundation as a Medical Device Development tool (MDDT).  This is the first FDA-approved computational modeling Medical Device Development Tool.

IMAnalytics is a software platform for the safety evaluation of implantable devices in the Magnetic Resonance (MR) environment. It characterizes RF-induced heating at the distal electrodes of implantable devices, using a variant of the Tier 3 approach as defined in ISO/TS 10974. It is tailored for elongated lead structures by making use of the transfer function method described in Annex K of the same technical specification.

Continue reading→

FDA Approves Boston Scientific’s ImageReady™ MRI For Vercise Gevia™ DBS

Posted on by Posted in Boston Scientific, Brain Stimulation, MRI-safe, Parkinson's Disease

 

Image Credit: Boston Scientific

Boston Scientific announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™  Deep Brain Stimulation (DBS) System to be used in a full-body MRI (1.5 Tesla MRI conditional when all conditions of use are met).  This system, with the Vercise Cartesia™ Directional Lead, is designed to treat the symptoms of Parkinson’s Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.

 

Sorin Announces CE Mark and Implant of its MRI-Compatible Kora 100 Pacemaker with Automatic MRI Mode

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, Sorin

Sorin Kora 100 MRI pacemaker David Prutchi PhD www.implantable-device.com

Sorin announced the CE Mark approval and first implant of its KORA 100 pacing system.

According to the press release:

KORA 100 SR and DR pacemakers when implanted with the Sorin BEFLEX pacing lead enable implanted patients to undergo magnetic resonance imaging (MRI) safely.[1] Pacemaker patients are typically older than 65 years. This patient population is prone to other medical conditions such as arthritis, cancer or stroke that may require MRI examinations for optimal diagnosis and management.

The KORA 100 pacing system has been designed with both patients and physicians in mind. Device settings which allow safe operation during an MRI examination are automatically enabled when KORA 100 pacemakers detect the scanner’s magnetic field. Similarly the devices sense when a patient leaves the MRI field, and return to normal operation within five minutes. The Automatic MRI Mode feature, which is patented and available exclusively on Sorin Group pacemakers, limits the amount of time that KORA 100 pacemakers operate in MRI mode.

Continue reading→

AAMI Technical Information Report Gives Guidance to AIMD Designers Regarding MRI Compatibility

Posted on by Posted in MRI-safe, Tech Talk

AAMI Guidance Implantable Device Compatibility with MRI

A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans.

ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform manufacturers about device behavior and patient risks so that MR-conditional AIMDs can be designed and labeled appropriately.  The introduction to the TIR explains:

Test methods described in this Technical Specification are primarily designed and intended as bench-top tests using equipment and techniques to simulate the fields (B0 static, gradient, and RF) found in MR 1.5 T scanners. Although, in a few cases, clinical scanner tests are implied, in all others, the AIMD manufacturer assumes the burden for development and validation of clinical scanner-based test methods.  Furthermore, the test signals and parameters specifically described within this Technical Specification for bench-top testing are not being encouraged or recommended for use on clinical scanners and to do so might result in scanner damage.

Medtronic SureScan Neurostimulators Cleared by FDA for Full-Body MRI

Posted on by Posted in Medtronic, MRI-safe, Pain, Spinal Cord Stimulation

Medtronic Restore Sensor MRI www.implantable-device.comFollowing Medtronic’s announcement in February of this year that it had introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions, the Company announced today that FDA has approved the system for use in the US.  Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature, which sets the device into an appropriate mode for the MRI environment.

The press release states:

“With the first U.S. implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc. (NYSE: MDT) is introducing the first and only implantable neurostimulation (also known as spinal cord stimulation, or SCS) systems for use in the treatment of chronic, intractable back and/or limb pain that are approved by the U.S. Food and Drug Administration (FDA) for conditionally safe* full-body Magnetic Resonance Imaging (MRI) under specific conditions.

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Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Posted on by Posted in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), MRI-safe, Tachycardia

Iforia MRI-compatible ICD/CRT CRT-D David Prutchi PhD www.implantable-device.comBiotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD.

Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector system, which is designed to simplify and shorten the implantation procedure. The DF4 connector combines the traditional three connectors into one, allowing for a more convenient implantation procedure without compromising safety.

Click here for the press release.

Medtronic Introduces First Neuromodulation Systems Compatible with Full-Body MRI

Posted on by Posted in Brain Stimulation, Medtronic, MRI-safe, Pain, Spinal Cord Stimulation

Medtronic Restore Sensor MRI www.implantable-device.com

Medtronic has introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions.  Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature, which sets the device into an appropriate mode for the MRI environment.

St. Jude Starts Trial of Accent MRI Pacemaker and Tendril MRI Lead

Posted on by Posted in Bradycardia, Cardiac Pacing, MRI-safe, St. Jude Medical
St Jude's ACCENT MRI MRI-compatible pacemaker. Report by David Prutchi PhD

Image Credit: St. Jude Medical

Today St. Jude announced the first implant in its Accent MRI(R) Pacemaker and Tendril MRI(R) Lead IDE Study (MRI Study). The ultimate goal of the study is to determine if patients with these devices can safely undergo full-body, high resolution Magnetic Resonance Imaging (MRI) scans to better accommodate their medical needs. The investigational Accent MRI Pacemaker system from St. Jude Medical offers an advanced pacing platform that provides wireless telemetry and algorithms to help address individual patient conditions.

Continue reading→