Nalu Micro-Implantable Pulse Generator Receives Expanded FDA Label for Service Life of 18 Years
CARLSBAD, Calif. (PRWEB) March 25, 2021
Nalu Medical, Inc. (“Nalu”), a California-based company that has successfully miniaturized neurostimulation implants for the treatment of chronic pain via Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS), in July 2020 received clearance from the U.S. Food and Drug Administration (FDA) of an expanded label for its micro-Implantable Pulse Generator (mIPG) to an expected service life of 18-years. The expanded service life labeling is attributed to the mIPG construction and testing for hermeticity and accelerated aging1, and is not limited to battery longevity.
The Nalu mIPG has no implanted battery and is powered wirelessly by an external Nalu Therapy Disc which contains control circuitry and a rechargeable battery. The external power source offers a distinct benefit over other IPGs that have implanted batteries, which require battery replacement surgeries.1 With the Nalu mIPG, battery replacement surgeries are eliminated, as are the risks and expenses associated with these types of surgeries.2,3 Additionally, the Nalu mIPG can be non-invasively upgraded so patients can benefit from FDA-authorized therapy advancements without additional surgical interventions.
“The Nalu Neurostimulation System was designed with external power and non-invasive upgradability to deliver long-term chronic pain relief treatment with minimal disruption for patients,” said Earl Fender, President and CEO of Nalu Medical, Inc. “With our expanded longevity labeling, physicians now have a compelling option for providing long-term relief for patients suffering from chronic, intractable pain of the trunk or limbs or severe intractable chronic pain of peripheral nerve origin.”
The Nalu mIPG service life extension follows other recent Nalu Neurostimulation System announcements including clearance for 1.5T Full-Body MRI scanning and preliminary clinical data presented at the 2021 North American Neuromodulation Society (NANS) Annual Meeting.
1. Data on file
2. Falowski SM, Provenzano DA, Xia Y, Doth AH. Spinal Cord Stimulation Infection Rate and Risk Factors: Results from a United States Payer Database. Neuromodulation. 2019;22(2):179-189.
3. Provenzano DA, Falowski SM, Xia Y, Doth AH. Spinal Cord Stimulation Infection Rate and Incremental Annual Expenditures: Results from a United States Payer Database. Neuromodulation. 2019;22(3):302-310.
About Nalu Medical
Nalu Medical, Inc. is a privately-held, medical device company located in Carlsbad, California. Our team of seasoned entrepreneurs, engineers and scientists have developed the next generation of miniaturized medical devices. These novel devices were designed and developed upon a proprietary, versatile technology platform that we believe will allow us to address several poorly treated clinical conditions. Our mission is to modernize, improve, and broaden the therapeutic capabilities in miniaturized medical devices, thus improving lives of people now and to meet the demands of medicine tomorrow.
About the Nalu Neurostimulation System
The Nalu Neurostimulation System and its micro-Implantable Pulse Generator (mIPG) are built upon the powerful, highly integrated nPower™ microchip platform, which combines a small form factor with broad capabilities to meet the diverse pain patient needs of today and the therapy possibilities of tomorrow. The nPower microchip delivers outputs similar to larger IPGs but with additional capabilities around waveforms, programming modes and upgradability. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation indications. To learn more, visit http://nalumed.com.
Indications for Use:
Spinal Cord Stimulation – The Nalu Neurostimulation System for SCS is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Peripheral Nerve Stimulation – The Nalu Neurostimulation System for PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Nalu, the Nalu logo and nPower are trademarks of Nalu Medical, Inc.