Altius Direct Electrical Nerve Stimulation System – P230020
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: Altius Direct Electrical Nerve Stimulation System
PMA Applicant: Neuros Medical, Inc.
Address: 26800 Aliso Viejo Parkway, Suite 250, Aliso Viejo, CA 92656
Approval Date: August 26, 2024
Approval Letter: Approval Order
What is it?
The Altius Direct Electrical Nerve Stimulation System is an implantable device to help reduce long-term (chronic) and difficult to manage phantom limb pain and residual limb pain in the legs of adult amputees post-amputation.
The main components of the Altius System are:
- an implanted pulse (signal) generator (IPG),
- one or two implanted cuff electrodes and attached lead(s),
- a battery pack and charger,
- a controller used by the patient, and
- a programmer wand used for communication between the programmer system (a program that provides a health care provider information)
An implanted cuff electrode is wrapped around the target nerve in the amputated leg. The attached lead is connected to the IPG, which receives signals from the controller to deliver a high frequency alternating current (HFAC) to the target nerve.
The Altius Direct Electrical Nerve Stimulation System is used to help reduce chronic and difficult to manage phantom and residual limb pain in the legs of adult amputees post-amputation.
Clinical study results support the effectiveness of Altius Direct Electrical Nerve Stimulation System to reduce chronic and difficult to manage phantom and residual limb pain in the legs of adult amputees post-amputation. Studies report a clinically meaningful reduction of pain relief of 50% or greater.
The Altius System should not be used in patients who:
- Are not able to operate the Altius System.
- Are not suitable for the Altius implant surgery.