A semiar on Altius Nerve Stimulation System .pptx

It contains a detailed description of the disease and case study

1. A SEMINAR ON ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM P J HEMANTH REDDY PHARM.D VI th year 19Y01T0018 CESCOP

2. Altius Direct Electrical Nerve Stimulation System The Altius Direct Electrical Nerve Stimulation System is an innovative medical device developed by Neuros Medical, Inc., specifically designed to manage chronic intractable pain associated with phantom and residual limbs in adult amputees. This system received FDA approval on August 26, 2024, as a breakthrough device due to its unique approach and potential to significantly improve patient outcomes. The Altius System offers a non-opioid solution for pain management, addressing the growing concerns surrounding opioid dependence and side effects. One of the key advantages of the Altius System is its patient-controlled nature, empowering individuals to manage their own pain relief without the need for constant medical supervision. Patients can initiate treatment sessions as needed, providing flexibility and immediate relief from pain. The system not only reduces reliance on opioid medications but also enhances the quality of life for amputees suffering from debilitating pain conditions, marking a significant advancement in pain management technology.

3. Indications The Altius® Direct Electrical Nerve Stimulation System is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Operating Principle The Altius Direct Electrical Nerve Stimulation System operates on the principle of delivering high-frequency alternating current (HFAC) directly to targeted peripheral nerves to alleviate chronic pain, particularly in individuals suffering from phantom and residual limb pain following amputation. The system comprises an implantable pulse generator (IPG) and one or two nerve cuff electrodes that are surgically implanted around the affected nerves, such as the sciatic, tibial, or peroneal nerves. The mechanism of action involves the application of HFAC through the nerve cuff electrodes, which creates a reversible conduction block in the targeted nerve fibers. This electrical stimulation interrupts the transmission of pain signals to the brain, effectively reducing the perception of pain. The therapy sessions are typically self-initiated by patients and last for about 30 minutes, allowing them to manage their pain on-demand. The system is designed to be patient-controlled, enabling users to activate it as needed for effective pain relief without the risks associated with opioid medications. This approach not only provides immediate analgesic effects but also promotes a sustainable and non-destructive method for managing chronic pain conditions related to limb loss.

4. Altius System Overview Programmer wand IPG and Cuff electrod Battery Charger Patient controller IPG and Cuff Elecetrode: Is a small, battery-powered electronic device that is implanted inside the body. The cuff electrodes connect the IPG to the nerves your HCP has targeted for treatment. Depending on your implanting doctor’s individualized treatment plan, one or two Nerve Cuff Electrodes can be connected to the Altius Implantable Pulse Generator. If you have one Cuff electrode it will typically be wrapped around your sciatic nerve in the residual limb, and if you have two cuff electrodes, they will be wrapped around the Common Peroneal nerve and the tibial nerve below where the sciatic nerve splits. The Altius IPG will most likely be implanted in your left or right abdomen. The Altius System is comprised of the following components: Altius System Implantable Pulse Generator and Cuff Electrode(s) Altius IPG Battery Charger Altius Patient Controller Clinician Programmer Wand

5. Altius System Patient Controller: The Altius System Patient Controller, or Altius Controller, is powered by two replaceable AA batteries. The patient controller allows you to choose to activate the 30-minute therapy when you need it. You can press either dose 1 or dose 2, and then bring it over your implanted IPG to activate the therapy. If, for any reason, you need to stop the therapy, you may press the off button and then hold it over your IPG. Altius IPG Battery Charger: The Altius Battery Charger is used to recharge your IPG.

6. Clinician Programmer Wand : External device used by physician or clinical user to set HFAC stimulus parameters for the Altius IPG. Contraindications Unable to operate the system Unsuitable for the Altius implant surgery Warnings Diathermy, Electromagnetic Interference [EMI], Patients with Diabetes, Risk of Asphyxiation, Magnetic Resonance Imaging (MRI), Lithotripsy, Electrocautery, External Defibrillation, Radiation Therapy, Ultrasonic Scanning, High-Output Ultrasound, Transcutaneous Electrical Nerve Stimulation [TENS]. Potential Adverse Effects Of The Device On Health Risks associated with any surgical procedure: B leeding ; hematoma; swelling; bruising; scarring; infection; injury to nerve, blood vessels, abdominal wall, and other tissue near the implanted components; pain at the location of implanted components. Risks associated with the use of the Altius System: Electrode or lead migration; IPG migration; allergic response or tissue reaction to the implanted material(s); hematoma or seroma at the implant site; skin erosion at the implant site.

7. Avoid changing the orientation of the Altius IPG or manipulating implanted components; contact your physician if the IPG flips or treatment doesn’t work after charging. Do not rub or manipulate the IPG through the skin to prevent damage, dislodgement, skin erosion, or stimulation at the implant site. Refrain from activities involving excessive or repetitive bending, twisting, bouncing, or stretching, as they may damage or dislodge components, requiring additional surgery. Avoid excessive bending of the torso to prevent stress on the implanted components. Inform massage therapists about the implanted device and avoid massaging areas near the IPG or cuff electrodes. Do not scuba dive below 10 meters (33 feet) or use hyperbaric chambers above 2.0 ATA without consulting your physician. Avoid starting treatment while walking or standing with a prosthesis to prevent sudden stimulation responses that may impair movement. Turn off stimulation before activities where unexpected jolts or shocks could cause harm (e.g., driving or operating power tools). Precautions

8. Follow your doctor’s instructions and report redness, swelling, drainage, or new symptoms. Avoid heavy lifting, rough contact, or blows to the implant site; contact your doctor if injured. Inform your doctor of long-distance travel or relocation plans for a referral. Follow restrictions on driving, returning to work, and prosthetic use as advised. Exercise, bathe, and manage pain or medications according to your doctor’s directions. Contact your doctor if you develop a fever lasting more than two to three days. Avoid tight clothing, rubbing the device, or excessive leg movements that may affect the lead system. Following Implantation Surgery

9. Reference: https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230020B.pdf https://www.neurosmedical.com/wp-content/uploads/2024/08/Patient-IFUs-Combined.pdf https://www.neurosmedical.com/wp-content/uploads/2024/08/Prescriber-IFUs-Combined.pdf https://www.accessdata.fda.gov/cdrh_docs/pdf23/P230020C.pdf

10. Thanks! P J Hemanth Reddy