Intellis™, the Next Generation Medtronic Spinal Cord Stimulator for Long-Term Management of Chronic Pain, Now Licensed in Canada

World's Smallest SCS Provides a Non-Opioid Treatment Option for Canadians Suffering from Chronic Pain

BRAMPTON, ON, Aug. 1, 2018 /CNW/ - Medtronic of Canada Ltd., a subsidiary of Medtronic plc (NYSE: MDT) today announced it has received a licence from Health Canada for its Intellis™ platform, which includes the world's smallest implantable spinal cord stimulator (SCS) for the management of certain types of chronic intractable pain. Chronic pain is a debilitating condition that 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 Given the national crisis involving opioid abuse, it is more important than ever for Canadians suffering from chronic pain to have access to new non-opioid treatment options.

The Medtronic Intellis Spinal Cord Stimulation (SCS) device and platform for treatment of chronic intractable pain. (CNW Group/Medtronic of Canada Ltd.)

"Persistent neuropathic pain is challenging to treat, and our goal should be to restore our patient's mobility and improve their quality of life with effective long-term pain relief," said Sean Christie, M.D., FRCSC, associate professor and director of research at Dalhousie University. "Considering the recommendations of Choosing Wisely Canada^*, it's more important than ever to find effective, long-term, non-opioid solutions. The availability of the Intellis spinal cord stimulator offers new possibilities for some patients struggling with debilitating pain."

Six million people in Canada report that they have a form of chronic pain.² Back problems are among the most common chronic conditions, with an estimated 30 percent of the patients that undergo lumbosacral spine procedures developing chronic intractable pain.¹ Medtronic neurostimulation therapy for chronic pain uses an SCS system, which is a medical device placed under a patient's skin to deliver mild electrical impulses through a lead implanted in the epidural space to block pain signals from going to the brain. Neurostimulation has been proven to provide effective long-term pain relief and improve quality of life, in addition to being a treatment option for patients interested in trying a non-drug alternative.^3-7

"Chronic pain affects up to 19 percent of Canadians," said Peter Tomashewski, senior director for Restorative Therapies at Medtronic Canada. "Intellis is an important innovation in the field of SCS for both physicians and patients alike. Transformative features and standardized guidance create a balanced approach enabling us to meet our goal of helping people with chronic pain have more freedom to do the things they love."

About the Intellis Platform
The Intellis platform includes the world's smallest implantable SCS neurostimulator and offers important patient benefits, including improving patient-physician communication by tracking and sharing daily activities such as body positions and therapy usage. This level of traceability can optimize treatment by providing physicians with an objective look at mobility and progress. The system also addresses a common patient complaint: the daily or weekly recharge burden. With Medtronic's proprietary Overdrive™ battery technology, the Intellis platform can be fully recharged in approximately one hour and is optimized for meeting the energy demands of high-dose (HD) therapy options offered in the Evolve™ Workflow.^†

The Intellis platform also allows the broadest access for MRI diagnostic imaging of most SCS systems.^‡ This is significant because studies show approximately 82 percent of patients implanted with an SCS system are expected to need an MRI within five years of receiving the implant.² The Intellis platform also has AdaptiveStim™ technology which automatically adjusts to deliver the right dose to the right location as the pain target shifts based on body position. See Instructions for Use for Indications, Contraindications, Warnings, and Precautions.

About Medtronic Canada
Proud to celebrate 50 years in Canada in 2018, Medtronic Canada (www.medtronic.ca), headquartered in Brampton, Ontario, is a subsidiary of Medtronic plc, which is one of the world's largest medical technology, services and solutions companies — alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 1,100 people in Canada, serving physicians, hospitals and patients across the country. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References:

1. Mekhail N, Wentzel DL, Freeman R, Quadri H. Counting the costs: case management implications of spinal cord stimulation treatment for failed back surgery syndrome. Prof Case Manag. 2011;16(1):27-36 Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Research and Management 2011; 16(6): 445–50
2. North RB., Kidd DH., Farrokhi F, et al. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurg; 56: 98–106 (2005).
3. Kumar K., Taylor RS., Jacques L, et al., Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicenter randomised controlled trial in patients with failed back surgery syndrome. Pain; 132: 179–188. (2007).
4. Kemler MA., De Vet HCW., Barendse GAM et al., The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years' follow-up of the randomized controlled trial. Ann Neurol; 55: 13–18 (2004).
5. 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; 31: S13–S19 (2006).
6. Cameron T, Safety and efficacy of spinal cord stimulation for the treatment of chronic pain – a 20 year literature review. J Neurosurg Spine; 100: 254–267 (2004).
7. Desai MJ, Hargens LM, Breitenfeldt MD, Doth AH, Ryan MP, Gunnarsson C, Safriel Y. The rate of magnetic resonance imaging in patients with spinal cord stimulation. Spine. 2015 May 1;40(9):E531-7.

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^* For more information on Choosing Wisely Canada, visit https://choosingwiselycanada.org/.
^† A workflow is guidance only and physicians should use their medical judgment and product labeling to optimize therapy for individual patients, which may require discontinuation or modification of a workflow.
^‡ Under specific conditions. Refer to product labeling for full list of conditions.

SOURCE Medtronic of Canada Ltd.

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