Medtronic announces FDA approval of the only deep brain stimulation system compatible with whole body nuclear magnetic scanning

Release date: 2015-12-16

DUBLIN – December 14, 2015 – Medtronic Co., Ltd. announced that its Activa® brain deep electrical stimulation Activa® series (DBS, commonly known as brain pacemaker) was officially approved by the US Food and Drug Administration (FDA). For conditional whole body magnetic resonance imaging (hereinafter referred to as MRI). To date, only the Medtronic DBS system has been approved for conditional nuclear magnetic compatibility. This approval allows patients to safely and screen for disease while using Medtronic as a vital test in the future while safely accepting Medtronic DBS treatment. Not only that, but this approval applies not only to patients who are about to accept the new Medtronic DBS system. The same applies to approximately 43,000 patients who are already receiving Medtronic DBS treatment in the United States as long as they comply with the updated Nuclear Magnetic Scanning Guidelines.
 
In 2013, a total of 33.8 million MRI scans were performed in the United States. Moreover, about 70% of patients with dyskinesia who are eligible for DBS treatment will need an MRI at the same time as they will receive DBS treatment in the next decade. MRI scans allow doctors to detect and/or monitor a wide variety of health conditions, such as stroke, dementia, dyskinesia, brain tumors, epilepsy, spinal disorders, cancer, musculoskeletal disorders and heart disease. Wait. MRI uses magnetic fields and radio wave technology to meticulously image organs and tissues. Unlike traditional X-ray and CT, MRI prevents patients from being exposed to electromagnetic radiation.
 
 
“Because many patients receiving DBS require MRI, but they cannot be obtained in a safe manner. For these patients, whole body nuclear magnetic scanning has become a critical and unmet need for them.” National Parkinson's Disease Foundation (NPF) National Medical Director Michael S. Okun said. “In order for MRI technology to benefit patients, important guidelines for how to apply this technology will also be issued by the hospital. The acquisition of this technology will be an important step in promoting a more optimized healthcare experience.”
 
Since the FDA approved the Medtronic MRI guidelines in 2002, patients using Medtronic brain pacemakers can receive head scans in the low frequency range, but the entire DBS system must be turned off before scanning. Now, with the implementation of the whole body nuclear magnetic compatibility technology, the enhanced nuclear magnetic RF energy will further improve the imaging quality, further accelerate the scanning time, or expand the scanning range to achieve a better diagnostic level. In addition, the Medtronic DBS system allows patients to accept MRI scans in the power-on mode, with appropriate stimulation patterns and certain other scanning conditions.
 
Dr. Lothar Krinke, vice president of Dulwich and general manager of brain deep electrical stimulation business, said: "MRI is becoming more and more important as a diagnostic tool. Medtronic is proud to be the first to offer a DBS system compatible with whole body nuclear magnetic scanning. Continuous innovation has made Medtronic unique, benefiting from DBS therapy and other systems implanted with Medtronic, such as pacemakers, ICD defibrillators and spinal cord stimulators, all compatible with nuclear magnetic scanning."
 
To improve the safety of the Activa® family of products in a systemic MRI nuclear magnetic scanning environment, Medtronic has developed a special test and measurement system in conjunction with advanced electromagnetic modeling tools. The Activa ® range of products has been rigorously tested and evaluated, with 10 million simulated patient scans and over 38,000 individual individual scans under implant conditions, validating the safety of nuclear magnetic compatibility with data. At this point, Medtronic has been escorting the clinical application and patient well-being of this technology with 14 years of MRI research and testing experience.
 
This new technology has not yet been approved for listing in China.
 
Data Sources:
* MR Conditional. Before conducting an MRI examination on a patient with any implanted Medtronic DBS device, please refer to the MRI guidelines for Medtronic deep brain stimulation systems located at
[1]. IMV. Benchmark Report: MR2013. Des Plaines, IL; IMV Medical Information Division, Inc.; 2013: 7.
[2]. Falowski S, Safriel Y, Ryan M, Hargens L. The need for magnetic resonance (MR) imaging in the United States (US) deep brain stimulation (DBS) population.Presented at: 18th Annual North American Neuromodulation Society Conference December 11-14, 2014; Las Vegas, NV.

Source: Kexun Medical Network

EV71 Nucleic Acid Test Kit

EV71 Nucleic Acid Test Kit

EV71 Nucleic Acid Test Kit

Guangdong Hecin Scientific, Inc. , https://www.hecinscientific.com