Here are five key notes:
1. The MR Conditional DBS systems are the only approved for full-body MRI scans. There are an estimated 43,000 people in the United States who are already receiving Medtronic DBS Therapy under the updated MRI guidelines.
2. Medtronic performed rigorous testing, including proprietary tests and measurement systems, to ensure the systems’ safety. Medtronic has 14 years of MRI research and testing experience.
3. The therapy is approved around the world for treating symptoms of the essential tremor, Parkinson’s disease and chronic intractable primary dystonia, which is approved in the United States under the Humanitarian Device Exemption.
4. There were 33.8 million MRI scans performed in the United States in 2013 and around 70 percent were DBS-eligible patients with movement disorders that may need an MRI within 10 years of receiving their device. The scans detect and/or monitor a wide range of conditions.
5. The FDA approved MRI instructions in 2002 and Medtronic DBS patients could receive head scans at a low frequency power limit since then. Now there is full-body scanning capability, increased MRI RF power limits for improved quality, faster scan times and larger scan coverage for better diagnostic capabilities.
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