Medtronic's Percept™ RC Rechargeable, Sensing-Enabled DBS System Receives CE Mark for Parkinson’s Disease and Epilepsy

Dec 08, 2023 00:07 CST Updated 00:08

Medtronic

Chronic Disease Medical Device and Therapy Developer

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2December 6, 2023, Medtronic (New York Stock Exchange code:MDT) announced that its rechargeable brain pacemaker, Percept RC, has received CE certification from the European Union.

*SIYU MedTech notes that relevant products from Chinese brands include the implantable rechargeable deep brain stimulator (NMPA approval No. 20233121566) by Jingyu Medical, among others. For more details, please check the official website of the National Medical Products Administration.

Medtronic stated that this is theThe Smallest, The Thinnest(DBS devices that allow for deeper implantation, while also being equipped with)BrainSense™ Sensing Technology, is the first rechargeable DBS device in Europe to adopt this sensing technology.

The device is currentlyIt is already available for purchase in Western Europe, has been launched in Japan, and is still awaiting FDA approval in the United States.After this device is certified in the EU, it can be used to treat the following diseases:

Parkinson's Disease:Parkinson's disease is a degenerative disorder of the central nervous system that commonly affects the elderly population. Typical patients exhibit three main symptoms: tremors (shaking hands), limb rigidity, and slow movement. The exact cause has not been fully elucidated, and there is currently no cure.

Essential Tremor:Essential tremor is a neurological disorder that is easily confused with Parkinson's disease. It commonly occurs in people over 40 and causes involuntary, rhythmic shaking (especially in the hands). The condition generally worsens over time and can be severe in certain populations.

Primary Dystonia:Dystonia is a movement disorder characterized by abnormal movements or postures caused by sustained or intermittent muscle contractions, which often recur and may interfere with a patient’s daily life. Primary dystonia, also known as idiopathic dystonia, is mainly hereditary.

Epilepsy:Epilepsy is a chronic disease characterized by recurrent seizures, which are caused by sudden abnormal discharges of neurons in the brain, leading to temporary dysfunction. Patients may experience severe convulsions of varying durations, potentially resulting in physical injuries or even fractures.

The principle of the product's function is throughUnilateral or bilateral electrical stimulation of deep brain structures (lymph nodes within the thalamus, subthalamic nucleus, or globus pallidus) as an adjunct to medication treatment for patients.。The features of the product are as follows:

Powerful battery function:AdoptedSuperfast Battery Technology, patients under normal circumstancesCan charge the battery from 10% to 90% within an hour.. ProductCan run continuously for 15 years on a charge(Charged once a week, battery capacity remains over 99% within 15 years);

Multifunctional Programming:OptiStim™ can assign intrinsic output values to each electrode to achieve the optimal stimulation shape, and ShapeLock™ can increase or decrease the stimulation while maintaining the stimulation shape. Additionally,The multi-rate feature allows users to choose between two different stimulation rates., so that different rates can be assigned separately to the electrodes of the left and right cerebral hemispheres or to different electrodes on the same lead;

Equipped with BrainSense™ Sensing Technology:Traditional DBS devices often provide one-way stimulation therapy, unable to offer clinicians data support for postoperative adjustment plans, thus preventing the clinical team from customizing treatment based on the patient’s specific condition. BrainSense™ sensing technology, on the other hand, is the result of over a decade of research by Medtronic's development team and is capable of collecting real-life data from patients (While applying electrical stimulation treatment to the patient's brain, it is possible to perceive specific EEG signals in the brain that are associated with disease symptoms.), and apply intelligent algorithm analysis to provide objective basis for doctors' treatment strategies, thereby offering personalized precision treatment to patients;

MRI Compatible:This DBS device isThe only rechargeable device that does not interfere with MRI scans. Under certain conditions, the patientMRI scans at 3T and 1.5T can be performed without turning off DBS therapy.Patients can use the accompanying software to check MRI compatibility, create MRI reports, and adjust stimulation settings suitable for MRI examinations (stimulation off or bipolar setting) before the scan.

Strong expandability:The software corresponding to the product can be updated subsequently.

Amaza Reitmeier, Vice President and General Manager of Medtronic Brain Modulation, said: "Percept RC isThe Only Rechargeable Neurostimulator Approved for Treating Epilepsy Patients...The potential of this device is limitless."

Amaza Reitmeier

# Medtronic's DBS Journey

In 1987, Medtronic, in collaboration with Professor Benabid, a French neurosurgeon and physicist, successfully carried outWorld's First Deep Brain Stimulation Surgery, marking the beginning of DBS therapy's clinical application worldwide.

In 1993, Medtronic's deep brain stimulator received CE certification for the treatment of essential tremor.

In 1997, Medtronic's brain pacemaker received FDA approval for the treatment of essential tremor and Parkinson's disease.

In 1998, Europe, Canada, and Australia successively approved Medtronic's brain pacemaker for the treatment of Parkinson's disease.

In 1999, Medtronic's brain pacemaker officially entered China, opening a new chapter in the surgical treatment of Parkinson's disease in China.

In 2003, the U.S. Humanitarian Device Exemption (HDE) approval and EU approval were granted for Medtronic's deep brain stimulation (DBS) therapy to treat primary dystonia.

In 2009, Medtronic launched the world's first rechargeable brain pacemaker, ACTIVA RC.Humanitarian Device Exemption Approval and EU Approval for Medtronic Deep Brain Stimulation in Treating Obsessive-Compulsive Disorder.

In 2010, Medtronic's brain pacemaker received CE certification for the treatment of drug-resistant epilepsy.

In 2013, MedtronicACTIVA PC+SHaving obtained CE certification, the brain pacemaker achieves simultaneous recording of field potentials while performing electrical stimulation treatment on the brain.

In 2015, Medtronic's ACTIVA series of brain pacemakers successively obtained CE certification and FDA approval, and are compatible with full-body MRI scans.The world's first enterprise to obtain official approval for MRI-compatible brain pacemakers。

In 2016, Medtronic's brain pacemaker received approval from China's National Medical Products Administration (NMPA) for the treatment of dystonia and drug-resistant epilepsy.

In 2019, Medtronic's Intelligent Perceptual Brain PacemakerPercept™ PCIt has successively obtained CE certification and FDA approval for marketing.

In 2022, Medtronic's intelligent and perceptible brain pacemaker Percept™ PC received approval from the China National Medical Products Administration (NMPA) for the treatment of Parkinson's disease, tremor, epilepsy, and dystonia.

In 2023, China's National Medical Products Administration approved Medtronic's Percept™ PC full implantable system for deep brain stimulation, which is compatible with both 3.0T and 1.5T full-body MRI scans.