by James Cavuoto, editor and Jeremy Koff, senior consulting editor
January 2021 issue
January 31, 2021 | Investigators affiliated with several vendors of neuromodulation systems presented findings at the 2021 meeting of the North American Neuromodulation Society earlier this month. The meeting, which was originally planned for Orlando, FL, took place via video conference.
At the meeting, Nevro announced results supporting the use of the company’s HF10 therapy for patients with chronic pain, including results from the painful diabetic neuropathy and non-surgical refractory back pain randomized clinical trials. Both trials demonstrated favorable results—at endpoints at six- and 12-months in the PDN study and three-months in the NSRBP study.
Nevro’s SENZA-PDN trial included 216 randomized subjects. Key findings at six months, presented by lead principal investigator Erika Petersen from the University of Arkansas for Medical Sciences, included significantly improved and sustained outcomes with 10kHz SCS versus conventional medical management. Data from the SENZA-PDN trial formed the basis of the company’s recent PMA supplement submission to the FDA.
Nevro’s SENZA-NSRBP RCT data included three-month primary endpoint results in 159 randomized subjects from 15 study centers. Key findings, presented by lead investigator Leonardo Kapural, from the Carolinas Pain Institute, included superior responder rate and significant pain relief for 10kHz SCS cohort versus conventional medical management. Other Nevro data presented at this year’s NANS meeting included the RESCUE study, which evaluated 120 patients who failed traditional SCS, and the Waveform Pairing study, which evaluated 230 patients who were provided waveform pairing programming to optimize their treatment. The RESCUE study demonstrated HF10 therapy as an effective therapeutic option to “rescue” failed traditional SCS patients with relief from chronic pain and provides more evidence that HF10 operates with a frequency-dependent mechanism of action. The Waveform Pairing study demonstrated increased versatility and waveform pairing may help improve therapeutic outcomes in difficult to treat patient populations.
Abbott announced the launch of NeuroSphere myPath, a digital health app designed to track and report on patient-perceived pain relief and general well-being associated with SCS or DRG therapy. During the device trial period required before the permanent implant, the app allows patients to record their outcomes on pain and well-being while trialing their neurostimulation therapy.
“The current digital healthcare landscape has revolutionized our ability to provide direct care for patients whenever they need,” said Shachi Patel, interventional pain management physician and owner of Delmarva Pain and Spine Center in Newark, DE. “By providing patients with a more seamless, easier way to record their progress during the trial period, Abbott’s NeuroSphere myPath app will enable an enhanced communication experience while providing patients with further insight on their overall outcomes and response to neuromodulation.”
Medtronic announced the first enrollment in ADAPT-PD, its trial evaluating the safety and efficacy of adaptive DBS in patients with Parkinson’s Disease. Adaptive DBS is an investigational feature of the Percept PC device that could be enabled if approved. The investigational feature used in this study allows for automated adjustment of brain stimulation to provide therapy to manage symptoms of PD based on a patient’s clinical state.
The randomized study will take place across 12 study sites at leading Movement Disorders research centers in the U.S., Europe, and Canada. An estimated 36 subjects will undergo a total evaluation period of 15 months. The primary endpoint of will compare standard continuous DBS to aDBS for hours of ‘On’ time without troublesome dyskinesias, a measure of treatment efficacy versus side effects, as reported by patient diary.
Saluda Medical presented European commercial results and sub-analyses of 24-month and 12-month clinical data from the Avalon Australian study and EVOKE investigational device exemption pivotal study. A number of posters and presentations focused on ECAP recordings for SCS. Charles Brooker presented a comprehensive analysis of Avalon 24-month data that showed 82.8 percent of patients reduced or eliminated opioids at 24 months and 41 percent were on 0 milligrams of morphine equivalents.
Nagy Mekhail presented a deep dive into the functional improvements and high responder data in the EVOKE RCT at 12 months, which demonstrated high levels of pain relief in parallel with high rates of mental health improvement, quality of life improvement, functional disability improvement, quality sleep improvement, and voluntary opioid reduction.
Shrif Costandi presented on the interconnectivity of sleep and pain, highlighting a nearly two-fold sleep improvement in the closed-loop arm in the EVOKE RCT, which equated to reporting more than one hour extra per night.
