For one million people diagnosed with Parkinson’s disease in the United States, Medtronic PLC, a world leader in health care technology, proudly announces the approval of the Food and Drug Administration (FDA) of the Deep Brain Stimulation (ADBS) and the Brainssense ™ electrode identifier (EI).
There is no remedy against debilitating neurological conditions like those of Parkinson, however, deep cerebral stimulation (DBS) has transformed the lives of people with Parkinson neurological disorders and others for more than 30 years. DBS is similar to a cardiac stimulator, but for the brain. It uses a neurostimulator surgically implanted via a mini-invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders.
Now Medtronic has improved its DBS perceptual neurostimulators with an exclusive Brainssense ™ adaptive technology, introducing ADB for people living with Parkinson. This feature personalizes therapy based on the brain activity of a patient in real time – both in clinical and daily life. It provides improved therapy customization for controlling the symptoms that automatically adjust, minimizing the need for patients to manually adjust stimulation.
“Medtronic is the only company in the world to offer an adaptive DBS system that dynamically adjusts therapy in real time,” said Brett Wall, executive vice-president and president of the neuroscience portfolio Medtronic. “This new era in Parkinson’s care represents more than a decade of intentional innovation – obtaining personalized large -scale neuromodulation which meets the changing needs of a patient, equipping clinicians with unrivaled ideas and establishing a new standard for DBS therapy.”
For over ten years, Medtronic has developed a complete DBS DBS system compatible with the detection of exclusive Brainsense ™ technology to detect, capture and classify various brain signals, putting Medtronic at the forefront of the incorporation of brain interface technology (BCI) in DBS therapy. Medtronic considers that BCI technology is a crucial element for developing innovative products that treat some of Parkinson’s cardinal symptoms by emphasizing the rehabilitation and restoration of health. The BrainSense ™ adaptive DBS is available for patients with DBS Medtronic with parkinson that have been located with a perceptal neurostimulator ™, as well as future patients with DBS Medtronic. With more than 40,000 DBS patients served worldwide with Medtronic Percept ™ devices, Brainsense ™ Adaptive DBS presents the largest commercial launch (by several amplitudes) of BCI technology – Never.
“The stimulation of the deep adaptive brain will help revolutionize the approach to therapeutic treatment of patients with Parkinson’s disease,” said Helen Bronte-Stewart MD MSE, Faan, Fana, John E. Cahill family teacher in the department of neurology and neurological sciences and director of the human engine control laboratory and neuromodulation of the Stanford University School Medicine. “Personalized transformer care that we can get thanks to an automatic adjustment greatly benefit patients who receive therapy that adapts to their evolving needs.”
Medtronic adaptive dbs algorithm for personalized therapy in the trial of Parkinson’s disease (adapt-PD) highlights the potential of ADB in clinical practice. Dr. Bronte-Stewart was the world’s main researcher for the test, which was conducted as an international, multicenter, prospective, prospective, a simple blind (between two ADB), and evaluated the safety and efficiency of Double ADB modes and Chronic Thrish compared to the DBS of DBS (CDBS) for patients with Parkinson. This study represents the largest and longest evaluation of ADBs in clinical and at home and has been developed in collaboration with more than a dozen renowned neurologists and neurosurgeonians
“For patients who have trouble with fluctuations in motor symptoms, dyskinesias and other side effects with CDBs, ADBs can provide better control of symptoms,” said Todd Herrington, MD, PHD, director of the deep cerebral stimulation program at the General Hospital Massachuses, Deputy Professor of Harvard Medical School and The adapt-PD test. “The approval of this therapy represents an important step for patients and I can’t wait to see the results of the adapt-PD study published soon.”
“Our brains technology provides unique and clinically important ideas that no other DBS system can offer, using a person’s own brain signals to provide a window on their state, in real time, over time,” said Paolo Di Vincenzo, president of the Neuromodulation activity, which is part of the portfolio of neuroscience in Medtronic. “Our goal has always been to create solutions that work for a real life, not just autonomous symptoms. Adbs reflects this commitment, providing a new expectation in the treatment of Parkinson.”
US FDA approval also includes the Medtronic Brainssense ™ electrode identifier (IS), which helps reduce patient time to clinic to program their DBS parameters. Using IS, clinicians can perform precise and precise initial programming, 85% faster compared to the traditional selection of electrodes .
The BrainSense ™ electrode identifier offers less ambiguity and greater efficiency compared to the traditional electrodes selection method by providing a personalized and real -time instantaneous and real -time instantaneous signals, which can help provide an overview of the ideal proximal point for programming. This new method reduces the selection time of initial contacts, rationalizing the process and ensuring more precise and personalized therapy for each patient. “”
Drew Kern, MD, MS, neurologist and associate professor of neurology, University of Colorado School of Medicine
“Our dedication to the progress of research and innovation of the DBS has transformed therapeutic options for people with movement and epilepsy disorders,” said Amaza Reitmeier, vice-president and general manager, neuromodulation Portfolio at Medtronic. “With this FDA approval, which quickly followed our CE brand, we take another step forward to provide personalized treatments compatible with detection to people with Parkinson.”
ADB and EI Brainssense ™ are also available (opens a new window) in Europe. In the United States, patient programs will start in certain health systems in the coming weeks with national availability in the coming months.
Since 1987, Medtronic has served more than 185,000 people with movement disorders and other indications in more than 70 countries with its CDBS therapy that changes their life. Patients who are considering DBS treatment should discuss processing options with their health care provider.