Clinicians and Researchers Attend INS 12th World Congress in Montreal

by James Cavuoto, editor

June 2015 issue

About 1400 clinicians, neural engineers, and researchers attended the INS 12th World Congress in Montreal, Canada earlier this month. The event was organized by the International Neuromodulation Society. The Canadian Neuromodulation Society organized a pre-conference public education meeting. Alim Benabid from the University of Grenoble in France was honored as the INS Giant of Neuromodulation award for his pioneering work in deep brain stimulation.

At a preconference meeting devoted to innovations in neuromodulation, executives from several startup neuromodulation firms made presentations. Alexendra Haessler, president of FemPulse LLC, in Larkspur, CA, described her firm’s noninvasive stimulation device to treat overactive bladder in women. The flexible, ring-shaped device fits around the cervix, allowing access to autonomic nerves and pelvic plexuses. Andy Hoffer, president of Lungpacer Medical Inc. in Burnaby, BC, showed his firm’s diaphragm pacing system. The temporary device uses intravenously inserted electrodes. The goal is to wean critically ill patients off of mechanical ventilators. The company has received $1.5 million in grants and awards thus far.

Neuronano AB of Karlshamn, Sweden described its flexible electrode interfaces that can stimulate specific targets while minimizing local inflammatory responses. The company hopes to find partners for applications in treating a number of neurological disorders.

Martin Schuttler from CorTec of Freiburg, Germany, described his firm’s long-term multi-channel brain implant recording and stimulation system. CorTec’s Brain Interchange platform enables closed-loop measurement and adjustable stimulation in near-real time.

Returning companies to the innovations session that gave updates included Neuros Medical, MicroTransponder Inc., Wise Srl, and SPR Therapeutics. SPR vice president Mark Stultz described some new activities beyond its current efforts in post-stroke shoulder pain, including a new therapeutic approach for post-amputation pain.

In a panel discussion devoted to venture capital, Kadir Kadhiresan from Johnson & Johnson Development Corp. described how his firm gets involved in developing new therapies. “We don’t just coinvent, we lead or co-lead,” he said. JJDC has also help “get the ball rolling” by encouraging J&J corporate to make coverage decisions for its employees. Tony Borowicz from Greatbatch’s new GB Ventures unit said his firm plans to make minority strategic investments between $2 to $5 million, and do three to five deals per year. “We’re not looking for a board seat,” he said.

At the meeting, Greatbatch, Inc.’s QiG Group announced that it will now do business as Nuvectra. The new company is commercializing the Algovita SCS system to treat chronic intractable pain of the trunk and/or limbs. “Nuvectra is focused on new ideas and approaches to implantable medical devices that improve the overall safety, efficacy, and usability for clinicians and patients,” said Tom Hickman, executive vice president for Greatbatch’s Nuvectra subsidiary.

The Algovita device has received CE mark and is currently in limited release in Europe. The system has been submitted to the FDA and the company anticipates approval in the second half of 2015. Greatbatch previously announced a proposed tax-free spin-off of the new entity. The spin-off is expected to be completed by the end of 2015.

Also at the meeting, St. Jude Medical presented data from the ACCURATE study of stimulation of the dorsal root ganglion with the Axium device obtained in the deal with Spinal Modulation. DRG stim is associated with superior pain relief over traditional SCS for the treatment of chronic pain of the lower limbs.

Patients in the study were randomized to receive either DRG stimulation or traditional SCS therapy delivered by a competitor’s system. After three months, investigators found the trial had met its primary endpoints for both non-inferiority and superiority over traditional SCS.

“Data from the ACCURATE Study are exciting because they demonstrate that DRG stimulation can offer meaningful improvement over traditional spinal cord stimulation for patients suffering from chronic pain conditions that have historically been challenging to treat,” said Mark Carlson, chief medical officer at St. Jude Medical.

SJM also announced CE Mark approval and the European launch of the invisible trial system, an app-based and wireless neuromodulation programming system leveraging Apple iPod touch and iPad mini technology. The system relies on Bluetooth communication, providing a secure, safe, and wireless experience when patients trial spinal cord stimulation for the treatment of chronic pain prior to permanent implantation.

In an interview with NBR, St. Jude Medical group president Eric Fain said that the Spinal Modulation acquisition and advances like the invisible trial system positioned the company well in the neuromodulation market. As opposed to a strategy of “swinging for the fences” in clinical trials, Fein advocated for a more orderly approach to commercializing new neuromodulation therapies.

Boston Scientific presented data from the LUMINA study demonstrating that the Precision Spectra SCS system provided 1.5 times better overall pain relief and 2 times better low back pain relief than the previous generation Precision Plus system. The improved outcomes were achieved in conjunction with the use of the company’s Illumina3D neural targeting software.

“The results are exciting because we looked at consecutive patients—some with only low back pain—in a real-world setting,” said Julie Pilitsis, associate professor, Albany Medical College and one of the lead investigators for this study.

New exhibitors at the meeting included Bioinduction, the parent company of UK-based Finetech, who showed a skull-mounted DBS platform. An Italian firm called NeurImpulse showed its subcutaneous PNS system for pain. And Mainstay Medical displayed its ReActiv8 stimulator for chronic low back pain.