Neuros Medical (Willoughby, Ohio) won an Investigational Device Exemption (IDE) approval from the FDA to introduce its Altius system in the U.S. The Altius consists of an implantable generator that has an integrated rechargeable battery, a cuff electrode, lead extension, and external control devices.
The generator uses the firm’s proprietary Electrical Nerve Block technology to disrupt nerve pain signals from reaching the brain.
From the announcement:
Neuros recently announced the results of their long-term pilot study which focused on patients afflicted with chronic amputation pain. 7 out of 9 study subjects, utilizing an external generator, reported
significant pain reduction (defined as 50% or greater) observed for up to 12 months of evaluation. The study demonstrated no safety issues over the treatment period. Study subjects reported an average pain score reduction of 6 to 1 (an 83% pain reduction) based on a 0 to 10 Numerical Rating Scale. In addition, more than half of the subjects discontinued their narcotic pain medication use during the study. Subjects enrolled in the long-term pilot study will now be able to utilize the implantable generator.
Product page: The Altius System…
Press release: Neuros Medical Receives Regulatory Approval for Implantable Device…
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