What is an HDE?
Humanitarian use devices are medical devices approved by the FDA for the treatment of medical conditions affecting fewer than 4,000 new patients per year. The FDA reviewed the safety of the device and determined that the probable health benefits outweigh the risks of injury or illness from its use. Effective treatment of symptoms, however, has not been studied in formal clinical trials. Surgery to implant Activa DBS for Dystonia can only be performed in medical centers that specifically approve its use.
