Nalu Receives FDA Clearance for 1.5T Full-Body MRI Scanning In Patients With Nalu Neurostimulation System Implants
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”.
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, early-stage medical device company located in Carlsbad, California. Our team of seasoned entrepreneurs, engineers and scientists are developing the next generation of miniaturized medical devices. Our novel devices are designed and developed upon a proprietary, versatile technology platform that 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, micro-Implantable Pulse Generator (IPG) built upon the nPower™ microchip platform, combines a small form factor with broad capabilities to meet the diverse pain patient needs of today and the therapy possibilities of tomorrow. The powerful, highly integrated nPower microchip 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 (SCS) and Peripheral Nerve Stimulation indications. To learn more, visit http://www.nalumed.com.
Nalu, the Nalu logo and nPower are trademarks of Nalu Medical, Inc.