Medtronic Receives CE Mark for the World’s Smallest Fully Implantable Spinal Cord Stimulator and Announces European Launch of the Intellis Platform

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Medtronic plc (NYSE:MDT) today announced that it received CE (Conformité Européenne) Mark for the Intellis(TM) platform for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) as an aid in the management of certain types of chronic pain.* Intellis, the world’s smallest fully implantable SCS neurostimulator, simplifies and improves the patient experience with improved battery performance that can power the EvolveSM workflow,** which standardizes guidance and balances high-dose (HD) and low-dose (LD) SCS therapy settings. The Intellis platform is managed on the Samsung Galaxy Tab S2 tablet interface and can record and track patient activity 24/7. Intellis is now available in Europe and the United States.

One in five adults in Western Europe suffers from chronic pain, a devastating condition with a costly personal and societal impact.1 Chronic pain can negatively impact all aspects of a person’s life – relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated.1

Published studies have shown that when used by carefully selected patients with chronic pain, SCS may provide effective long-term pain relief, improved quality of life and pain-related disability, and may reduce the need for pain medications.2 Similarly, PNS may also provide back pain relief, improvement in back pain-related disability, and reduce the need for pain medications.3-4 The potential benefits of neurostimulation are critical given the public health issue of prescription pain medication abuse.5

Earlier intervention with SCS has been shown to improve treatment outcomes6 and SCS is widely reimbursed and recommended by European governments.7-9 Current European guidelines support the use of SCS; failed back surgery syndrome is the primary indication recommended by European governments.10

The first European patient received the Intellis system at the Pain Clinic of AZ Nikolaas Hospital in Sint-Niklaas, Belgium where Prof. Jean-Pierre Van Buyten is Chairman and the procedure was performed by Dr. Iris Smet.

Dr. Iris Smet from AZ Nikolaas said, “Chronic pain is a complex disease that is challenging to manage. The innovations behind the Intellis platform translate into meaningful patient benefits and ease of use for physicians, which represent important advantages over other neurostimulators.”  He added, “I want to restore my patient’s health and improve their quality of life; the innovation behind the Intellis platform allows me to achieve that and help a broad range of patients.”

The Intellis platform can help optimize treatment and improve patient-physician communication by tracking and sharing daily activities, body positions and therapy usage and giving physicians an objective look at mobility and progress.

“Rather than rely on patient-reported data, the enhanced activity tracker of the Intellis platform provides real-time data that offers more visibility into quality of life changes,” notes Prof. Jean-Pierre Van Buyten of AZ Nikolaas. “Better understanding a patient’s experience can lead to a more informed conversation that can help me maximize their pain relief and this information is easy to see and act on with the improved Samsung Galaxy tablet physician programmer.”

“Medtronic’s goal is to simplify treatment and improve the patient experience with personalized therapy that provides long-term pain relief and helps restore function,” said Marshall Stanton, M.D., senior vice president and president of Medtronic’s Pain Therapies division, which is part of the Restorative Therapies Group. “The launch of the Intellis platform is the culmination of 40 years of innovation and what makes Intellis such an important option is that it integrates leading-edge hardware with the Evolve workflow for SCS to help optimize pain relief.”


References:

  1. Breivik H, European Journal of Pain 10 287-333 (2006).
  2. Taylor RS, Spinal cord stimulation in Complex Regional Pain Syndrome and Refractory Neuropathic Back and Leg Pain/Failed Back Surgery Syndrome: results of a systematic review and meta-analysis. J Pain Symptom Manage. 2006; 31: S13-S19.
  3. Kloimstein H, Likar R, Kern M, et al. Peripheral Nerve Field Stimulation (PNFS) in Chronic Low Back Pain: A Prospective Multicenter Study. Neuromodulation. 2013;17(2):180-187.
  4. McRoberts WP, Wolkowitz R, Meyer DJ, et al. Peripheral nerve field stimulation for the management of localized chronic intractable back pain: results from a randomized controlled study. Neuromodulation. 2013;16(6):565-575.
  5. Shei, Amie, et al., Estimating the health care burden of prescription opioid abuse in five European countries. Dove Press 2015:7 Pages 477-488
  6. Kumar K., Hunter G., Demeria D et al., Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery; 58: 481-496 (2006).
  7. Haute Autorité de Santé. Evaluation des systèmes implantables de neurostimulation médullaire. Service d’évaluation des dispositifs. Saint-Denis La Plaine : HAS ; 2014.
  8. AWMF S3 Leitlinie: Epidurale Rückenmarkstimulation zur Therapie chronischer Schmerzen, Stand 07/2013; Online:http://www.awmf.org/leitlinien/detail/ll/008-023.html.
  9.  Cruccu, G., Garcia-Larrea, et al, EAN guidelines on central neurostimulation therapy in chronic pain conditions. Eur J Neurol, 23(10):1489-99 (2016).

* The Intellis SCS neurostimulation system is indicated for SCS as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

The Intellis PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the posterior trunk.

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