Medtronic Receives FDA Approval for Expanded MRI Compatibility of Its Deep Brain Stimulation Systems

Aug 22, 2024 17:38 CST Updated 17:38

Medtronic

Chronic Disease Medical Device and Therapy Developer

Source: Siyu MedTech; Editor: Sophia

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On August 21, 2024, Medtronic announced,The U.S. FDA approved its brainDeep Brain Stimulation (DBS)Extension MRI Label for Deep Brain Stimulation (DBS) Systems,Including Medtronic's Percept PC and RC, as well as Activa PC, RC, and SC systems.

# Approval Details

Medtronic's BrainDeep Brain Stimulation (DBS)The expansion of the MRI label for the Deep Brain Stimulation (DBS) system, approved by the U.S. FDA, marks a significant advancement.

This generally means that the system can now be safely used during magnetic resonance imaging (MRI) examinations.Provides greater convenience and flexibility for patients receiving DBS device therapy.

Compatible Advantages:

Patients can safely undergo MRI scans after DBS device implantation.Helpful in diagnosing newly emerging or other diseases unrelated to the primary condition, such as neurodegenerative diseases, tumors, stroke, traumatic brain injury, and infections, etc.
Postoperative MRICan confirm whether the electrode is accurately implanted into the predetermined deep brain nucleus., ensure the surgical outcome.
For DBS patients requiring long-term management, MRI compatibilityReduced imaging limitations during the follow-up period, which is helpful for long-term monitoring and evaluation of treatment effectiveness.
Monitoring treatment effects and adjusting stimulation parameters through MRI scans help achieve more precise personalized treatment.

It is reported that thisThe class label certification, unique to the Medtronic DBS system, allows for additional active scan time when scanning below the specified B1+rms limit.

Note: B1+rms is an indicator for measuring the intensity of the radiofrequency magnetic field, directly related to the safety of MRI scans.

# Executive Evaluation

Vice President of Medtronic Neurological ModulationCEO and General Manager Amaza Reitmeier stated:

"Patients with movement disorders experience symptoms such as tremors, severely impacting their ability to perform daily activities. They require treatments like MRI. This label expansion is another example of our commitment to achieving personalized patient care."

Medtronic Neurological Modulation Chief Medical Officer Ashwini Sharan stated:

"It is estimated that nearly 70% of all patients relying on DBS also require MRI. In certain cases, only the Medtronic DBS system can continue treatment in bipolar mode while the patient undergoes an MRI scan."

Since 1987, Medtronic has provided life-changing DBS therapy to more than 180,000 patients with movement disorders and other conditions across 70 countries.

# Percept Series

1. Percept RC Deep Brain Neurostimulator

Medtronic offers its latest generation of perceptible and rechargeable brain pacemaker, Percept.™ RC，Used to treat Parkinson's disease, essential tremor, dystonia, and epilepsy.

▲Medtronic Percept RC Deep Brain Stimulator

Product Features

BrainSense™ Brain Sensing Technology：Percept RC Deep Brain StimulatorBuilt-inBrainSense™ Brain Sensing Technology，Can capture EEG signals associated with specific disease symptoms simultaneously during treatment., and utilize intelligent algorithms for analysis to provide objective evidence for doctors' treatment strategies.

Directional Electrode SystemSenSight™：Achieved directional stimulation,Through a unique 1-3-3-1 rounded segmented eight-contact design, the stimulation direction can be freely adjusted, and the current of each contact can be independently controlled, thereby precisely targeting the desired nuclei while avoiding unnecessary stimulation of other brain areas.

Adopting NASA aerospace material technology, it achieves directional stimulation and is equipped with BrainSense™ brain sensing technology and richer, more efficient programming functions.Patients can undergo clinical 3.0T and 1.5T magnetic resonance imaging (MRI) examinations.

Convenient Charging:Simply place the portable wireless charging device on the chest, and it can wirelessly charge the implanted device via Bluetooth.It only takes about 1 hour to charge from 10% to full.。

2. Percept™ PC Neurostimulator

Percept PC Compared with Medtronic's previous generation brain pacemaker, Activa PC20% smaller, 20% thinner, weighing only 61g, and designed to be more ergonomic, significantly improving patient comfort.

Percept PCDespite its compact size, itBattery life lasts up to 15 years, and has stable and fast charging performance.

Compared with other rechargeable brain stimulators, the battery with Medtronic's unique patented battery technology fades less, providing a more reliable and longer-lasting battery; the charging speed is also very fast.90% of the battery can be charged within 1 hour.。

Percept PC isThe world's first DBS system fully certified by China's NMPA, EU CE, and US FDA, compatible with both 3.0T and 1.5T whole-body MRI scans.(Including deep brain neurostimulator, deep brain neurostimulation electrodes, and extension leads)

# Activa Series

IncludingActiva™ PC, Activa™ RC, and Activa™ SCThree models,Among them:

Activa™ RC：The world's first rechargeable DBS system, with a service life of up to 15 years. It also allows for precise programming of electrical stimulation to meet the needs of different patients.
Activa™ PC：Can perform electrical stimulation on both sides of the patient's brain simultaneously.
Activa™ SC：Applicable to patients who only need electrical stimulation on one side of the brain.

The Activa™ series DBS system utilizes sensing technology and adjustable stimulation algorithms.While providing deep brain therapy, it can also measure and record the electrical signals in key areas of the brain.。

In addition, the system's accompanying programmable control system supports doctors in making real-time programmable settings on a tablet computer based on reliable patient data information.

As of the latest data, Medtronic's Activa™ series has been widely used for treatment.Parkinson's disease, essential tremor or Parkinsonian tremor, dystonia, epilepsy, and obsessive-compulsive disorderAnd many other physical and mental illnesses.

# Conclusion

MRI compatibility makes the DBS system suitable for a wider patient population, including those who may require MRI scans to monitor other health issues.

In addition, from a research perspective, researchers can also dynamically display brain region activity through technologies such as functional magnetic resonance imaging (fMRI), which helps to reveal disease mechanisms and optimal stimulation parameters.

Editor-in-Chief | Zhao Qing Reviewed by | Yi He