1. Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes from the AUS-nPower Study During the COVID-19 Pandemic
- Author
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Salmon,John, Bates,Daniel, Du Toit,Neels, Verrills,Paul, Yu,James, Taverner,Murray, Mohabbati,Vahid, Green,Matthew, Heit,Gary, Levy,Robert, Staats,Peter, Kottalgi,Shilpa, Makous,James, Mitchell,Bruce, Salmon,John, Bates,Daniel, Du Toit,Neels, Verrills,Paul, Yu,James, Taverner,Murray, Mohabbati,Vahid, Green,Matthew, Heit,Gary, Levy,Robert, Staats,Peter, Kottalgi,Shilpa, Makous,James, and Mitchell,Bruce
- Abstract
John Salmon,1 Daniel Bates,2 Neels Du Toit,2 Paul Verrills,2 James Yu,3 Murray G Taverner,4 Vahid Mohabbati,5 Matthew Green,6 Gary Heit7 ,â Robert Levy,8 Peter Staats,9 Shilpa Kottalgi,10 James Makous,11 Bruce Mitchell2 1Pain Management, Pain Care Perth, Perth Cottesloe, WA, Australia; 2Pain Management, Metro Pain Group, Melbourne, VIC, Australia; 3Pain Management, Sydney Spine and Pain, Sydney, NSW, Australia; 4Pain Management, Frankston Pain Management, Frankston, VIC, Australia; 5Pain Management, Sydney Pain Management Centre, Sydney, NSW, Australia; 6Pain Management, Pain Medicine of South Australia, Adelaide, SA, Australia; 7Department of Neurosurgery, Hue University of Medicine and Pharmacy, Hue, Vietnam; 8Neurosurgery, Institute for Neuromodulation, Boca Raton, FL, USA; 9Premier Pain Centers, Shrewsbury, NJ, USA; 10Clinical Department, Nalu Medical, Inc, Carlsbad, CA, USA; 11Makous Research, LLC, Carlsbad, CA, USAâ Gary Heit passed away in February 2023Correspondence: John Salmon, Pain Management, Pain Care Perth, 2/89 Forrest Street, Perth Cottesloe, WA, 6011, Australia, Tel +61 428 246 846, Fax +61 8 92845759, Email Salmon8@bigpond.comPurpose: Spinal cord stimulation (SCS) is a highly effective treatment for chronic neuropathic pain. Despite recent advances in technology, treatment gaps remain. A small SCS system with a miniaturized implantable pulse generator (micro-IPG; < 1.5 cm3 in volume) and an externally worn power source may be preferred by patients who do not want a large, implanted battery. We report here the long-term outcomes from the first-in-human study evaluating the safety and performance of a new neurostimulation system.Patients and Methods: This was a prospective, multi-center, open-label, single-arm study to evaluate this SCS system, in the treatment of chronic, intractable leg and low-back pain. Consented subjects who passed screening continued on to the long-term phase of the study. One-year, patient-reported outcomes (PROâs) suc
- Published
- 2024