Device Vendors Take Stage at North American Neuromodulation Society Meeting

by James Cavuoto, editor

December 2014 issue

Neuromodulation industry professionals joined with clinicians, researchers, and neural engineers at the 2014 meeting of the North American Neuromodulation Society, held in Las Vegas, NV earlier this month. Attendance exceeded 2000 at the rapidly growing meeting.

NANS sponsored a day-long commercialization session called Invention, Investment, and Invigoration prior to the scientific meeting. Ali Rezai from Ohio State University offered his views on future developments in brain neuromodulation. He stressed that advances in personalized and multidimensional targeting would be critical in future DBS therapies. He also advocated advances in robotic and image-guided neurosurgery to streamline the implantation process.

With respect to DBS for psychiatric disorders, Rezai highlighted the need for biomarkers that could aid patient selection and predict likely response to neuromodulation therapies. He also called for more progress in active, adaptive DBS therapy and in automated programming.

In a roundtable discussion, executives from the four major neuromodulation firms presented their views on innovation in the years ahead. The executives agreed that we are still at the early stage of growth in the neuromodulation industry and that vendors need to drive penetration of their devices, which is still in the single digits for most targeted disease populations. Rohan Hoare from Cyberonics noted that the neuromodulation industry is one-tenth the size of the cardiac device industry yet offers many more indications. He cited physician awareness and education as important goals for the industry.

Hoare also pointed out that devicesales in the cardiac market are driven by cardinal events such as heart attacks. No analogous event exists in the neuromodulation device market. Patients can often live with chronic neurological disorders until they gradually worsen to the point where intervention is necessary.

Eric Fain from St. Jude Medical agreed that the evolution of the neuromodulation industry would not necessarily follow the same path as cardiac devices but he defended his company’s decision to combine cardiac rhythm management with neuromodulation in an implantable device business unit. Noting the commonality of electronic components like leads and pulse generators, Fain said the company was uniquely positioned to leverage the mass provided by CRM devices. He said the biggest competitive issue confronting neuromodulation device vendors was sales of opioid pharmaceuticals and he admonished his colleagues to see opioid abuse as a competitive opportunity. Fain pointed out the irony that neuromodulation devices vendors worried about serious adverse events amounting to fractions of a percent while the pharmaceutical industry tolerates tens of thousands of deaths from opioid overdose.

Tom Tefft from Medtronic stressed the importance of delivering quality of life with neuromodulation therapies. He said the industry needs to knock down some of the societal barriers to implanted stimulation and overcome the perception that neuromodulation is only to be used as a “last resort” therapy.

Maulik Nanavaty from Boston Scientific said that the industry needs to identify ways to expand the market for neuromodulation devices and further innovation. He said that as new indication emerge, it’s important to at least remain a player so that when technology matures you can jump in. He also advised that it’s worthwhile to get patients more involved in their own care in the future.

In a keynote speech on bioelectronic medicine, Kevin Tracey from the Feinstein Institute for Medical Research explained the cytokines theory of disease and how neuromodulation of the vagus nerve inhibits production of these disease-inducing agents. He said that drugs currently on the market to control cytokines cost on the average of $20,000 to $25,000 per patient per year, which represents about 5 percent of the overall market for pharmaceuticals. Tracey stressed that understanding the mechanism of action of bioelectronic therapies is essential and that the industry should design devices based on neurophysiological systems.

At the meeting, St. Jude Medical showed its new Protégé IP. The company bills it as the industry’s first system to allow patients to upgrade their device via software updates, allowing access to future therapies when approved without surgical IPG replacement. The company also presented research findings that examine the effects of burst stimulation on reducing pain levels in patients who don’t respond to traditional tonic stimulation.

Investigators affiliated with Boston Scientific presented new retrospective data evaluating the company’s Precision Spectra SCS system, which indicate that the device provided sustained, highly significant relief of low back pain 12 months after implantation.

Results from the PRO Study were presented. The outcomes review of 213 patients at 13 centers focuses on patients with chronic pain and chronic low back pain receiving treatment with the Precision Spectra SCS system. The system’s Illumina 3D software, an anatomy-driven computer model designed for simple point-and-click pain targeting, helps to address a key challenge in long term back pain relief: stimulating the neural target without stimulating undesired areas.

At 12 months post-implantation, results include sustained and significant reduction in overall pain, sustained and significant reduction of low back pain. “Treating low back pain has been challenging because so many therapies have had mixed results,” said Salim Hayek, chief, division of pain medicine at University Hospitals of Cleveland and lead study investigator. “These results demonstrate that the Precision Spectra System can provide effective, long-term relief for patients suffering from this difficult to treat condition.”

Investigators affiliated with Nevro Corp. provided positive results from the SENZA-RCT pivotal trial of 241 patients.