Neuromodulation Vendors Show Advanced Pain Therapies at 2018 NANS Meeting
by James Cavuoto, editor
January 2018 issue
Nearly 3000 clinicians, researchers, and neural engineering professionals attended the 2018 meeting of the North American Neuromodulation Society, held in Las Vegas, NV earlier this month.
Advances in spinal cord stimulation for treating chronic pain featured prominently in this year’s meeting. In an opening plenary talk, Stephen Falowski from St. Luke’s hospital discussed the issue of awake versus nonawake patients during SCS implantation procedures. He cited several advantages of nonawake procedures, including efficiency—about 25 percent faster—and better accuracy in lead placement using EMG monitoring. Falowski’s team has developed a neuromonitoring protocol for both traditional and DRG implantations. The codable protocol only adds $100 to $150 to the cost of the procedures.
Howard Fields from UC San Francisco gave an enlightening talk on the neural basis of the placebo effect. Placebos activate top-down pain modulating circuits, he said. Pain and reward predictive cues activate the ventral striatum and the mu morphine opioid receptor.
Timothy Deer from the Center for Pain Relief in West Virginia presented two-year data from Abbott’s SUNBURST study of burst stimulation. Abbott’s BurstDR waveform was selected by a majority when they were allowed to choose during the long-term follow-up period. Each patient was exposed to both therapies and preference for BurstDR improved over time. Allen Burton, Abbott medical director for neuromodulation said: “The BurstDR waveform is by far the most studied waveform in neurostimulation. It’s clear to the physicians we’re working with that Abbott is committed to ongoing research and real-world evidence.”
Boston Scientific Corp. announced positive results from the company’s WHISPER randomized controlled trial. The data demonstrated that patients who are given the choice to use both sub-perception and paresthesia-based SCS therapy achieve superior outcomes compared to patients who have only one SCS therapeutic option.
The WHISPER RCT is a multi-center, prospective, cross-over, randomized, and controlled study that evaluated the long-term safety and effectiveness of sub-perception SCS therapy. Participants had been implanted with an SCS system for an average of four years at the beginning of the study and were treated with both paresthesia and sub-perception therapy.
“The WHISPER RCT evaluated both patients who had successfully controlled their pain using SCS and those who could benefit from additional options and optimization of their therapy,” said James North, from the Carolinas Pain Institute, and coordinating principal investigator of the trial. “This study provides data on people who have suffered with chronic pain for years and who pose some of the biggest challenges in the long-term use of SCS. The results demonstrated that giving patients the choice to use sub-perception or paresthesia-based therapy provides superior patient outcomes and affirms SCS is a clinically valuable treatment option.”
The study expands on research from the PROCO RCT, which established in de novo patients that similar pain relief and improvement in quality of life measures are experienced independent of the type of frequency (from 1 kHz up to 10 kHz) used in sub-perception SCS therapy when the proper target and dose are identified.
Nevro Corp. announced FDA approval of the company’s Senza II SCS system at the meeting. Several investigators affiliated with Nevro described ongoing studies of the company’s HF10 parasthesia-free therapy. SENZA-ULN is a prospective, multicenter clinical trial that evaluated HF10 therapy in subjects with chronic, intractable neck and/or upper limb pain. Patients treated with HF10 therapy experienced significant pain reduction at 12-month follow-up for upper limb and neck pain The data was presented by Kasra Amirdelfan from Integrated Pain Management Medical Group.
SENZA-PPN is a prospective, multicenter study evaluating HF10 therapy for the treatment of peripheral polyneuropathy, with compelling and consistent interim results at six months that have since prompted the initiation of a large-scale randomized clinical trial for painful diabetic neuropathy (SENZA-PDN). The data was presented by Sean Li from Premier Pain Centers. SENZA-NSRBP is a randomized, controlled, multicenter trial evaluating HF10 therapy for non-surgical refractory back pain. Adnan Al-Kaisy from St, Hospital presented data.
“Our large and growing body of clinical evidence supports the use of HF10 therapy for patients suffering from debilitating chronic pain and looking for alternatives to opioids,” said Rami Elghandour, president and CEO of Nevro. “With a number of studies initiated in a variety of pain areas and indications, we are uniquely positioned to deliver on the promise of neuromodulation by applying our best-in-class therapy to treat a broad array of challenging disease states. In today’s environment, patients and physicians are seeking non-pharmacologic solutions and we are committed to helping patients regain their lives by doing this important work. “
Investigators affiliated with Bioness presented data from four studies demonstrating the clinical benefits of the company’s StimRouter device. Researchers from the Icahn School of Medicine at Mt. Sinai, Stanford Medical School, the University of Toronto, and The Pain Management Center examined how the StimRouter can be applied to chronic pain conditions, originating from the peripheral nerve region of the shoulder, tibia and other areas of the body.
Topics presented during poster session included the use of ultrasound for placing the device, the use of peripheral nerve stimulation for the treatment of tibial neuralgia, and peripheral nerve stimulation for chronic idiopathic orchialgia, and novel lead placement for suprascapular nerve peripheral nerve stimulation.
Investigators affiliated with SPR Therapeutics presented positive results of peripheral nerve stimulation with the company’s Sprint percutaneous device. These included applications in treating post-stroke shoulder pain and post knee-replacement surgery.