Nalu Receives FDA Clearance for 1.5T Full-Body MRI Scanning In Patients With Nalu Neurostimulation System Implants
by CARLSBAD, Calif. (PRWEB) December 4, 2020
Nalu Medical, Inc. (“Nalu”), a company that provides miniaturized neuromodulation implants for the treatment of intractable chronic pain, has received FDA 510(k) clearance for expanded labeling that allows for full-body 1.5 Tesla (T) magnetic resonance imaging (MRI) in individuals with select Nalu Spinal Cord Stimulation (SCS) implants. This clearance is retroactive to currently implanted SCS patients and considered MRI-Conditional. With a conditional classification, MRI scans can be safely administered under certain conditions, including specific requirements with respect to the type of MRI scanner, implant configuration and anatomical location, among other. The MRI safety labeling also includes 1.5T and 3T scans of the head and extremities for SCS and Peripheral Nerve Stimulation (PNS) Systems.
In today’s medical practice, MRI scans are necessary and routinely performed for diagnosis and clinical care. It is very likely that a patient with chronic pain will require a future full-body MRI scan.1,2 The clearance for full-body MRI labeling removes a potential barrier for eligible patients to select the Nalu Neurostimulation System as a means to help manage their chronic pain.
“Expanding our MRI label from head and extremity only to full-body is a significant factor for extending our reach across the United States,” said Earl Fender, Nalu’s President and CEO. “With this clearance, clinicians can now recommend our life-changing therapy to eligible patients with fewer concerns about future imaging. It also underscores Nalu’s ongoing commitment to advance medical devices with miniaturized technology to provide meaningful differences in patients’ lives.”
“When evaluating neurostimulation systems best suited for my patients, I always consider their immediate and long term needs with regards to disease progression and imaging,” said Dr. Dawood Sayed, MD, Associate Professor University of Kansas School of Medicine and Division Chief of Pain Medicine. “The small size and broad capabilities of the Nalu implant is something that is especially important to many of my patients. Adding full-body conditional MRI allows me to offer this effective therapy to an even greater number of patients with chronic pain, while maintaining more of my patients’ available imaging options”.
References:
1. Sayed D, et al. Neuromodulation. (2020) 23:893–911.
2. Desai MJ, et al. Spine. 2015;40(9):E531–E537.
About Nalu Medical
Nalu Medical, Inc. is a privately-held, medical device company located in Carlsbad, California. Our team of seasoned medical device professionals have developed the next generation of miniaturized medical devices. The result is a novel, versatile and upgradeable technology platform that we believe will allow us to address several poorly met needs in the market. Our mission is to modernize, improve, and broaden the therapeutic capabilities of miniaturized medical devices, thus improving lives of people today and addressing the demands of medicine tomorrow.
About the Nalu Neurostimulation System
The Nalu Neurostimulation System, an implanted treatment for managing intractable chronic pain, consists of a fully-featured micro-Implantable Pulse Generator (mIPG™) free of an implantable battery and powered by an externally worn Therapy Disc and controlled by the patient via a smartphone app. The Nalu mIPG is built upon the nPower™ microchip platform that delivers outputs similar to larger IPGs but with additional capabilities around waveforms, programming modes and upgradability. The Nalu mIPG is currently cleared by the FDA for both Spinal Cord Stimulation and Peripheral Nerve Stimulation indications with an expected service life of 18 years. To learn more, visit www.nalumed.com.
Indications for Use
Spinal Cord Stimulation – The Nalu SCS system 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 (≤ 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Peripheral Nerve Stimulation – The Nalu PNS system 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 (≤ 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Nalu, the Nalu logo, mIPG and nPower are trademarks of Nalu Medical, Inc.