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First Procedure in India Performed With Intellis™ Rechargeable Spinal Cord Stimulator for Chronic Pain Management
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                            Mumbai, Maharashtra, India:
                         First patient in India treated at Jaslok Hospital and Research Centre, Mumbai
Includes the world’s smallest implantable spinal cord stimulator

India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE: MDT) — a global leader in healthcare technology, today announced the first clinical procedure in India with the Intellis™ spinal cord stimulation (SCS) platform, the world’s smallest SCS device for the management of certain types of chronic intractable pain. Dr. Paresh Doshi, director of neurosurgery at the Jaslok Hospital and Research Centre, Mumbai, successfully implanted the first Intellis device in a patient in India for the management of pain.
 
More than 19% of the Indian adult population suffers from chronic pain of some kind.1 Respondents of an epidemiological telephonic survey with chronic pain in India were no longer able to exercise, sleep, maintain relationships with friends and family, and maintain an independent lifestyle. About 32% of patients lost ≥4 hours of work.2
 
The Intellis platform offers DTM™ SCS therapy, a unique differential target multiplexed spinal cord stimulation programming option to treat patients with chronic pain. DTM SCS therapy, which is proven only on the Medtronic Intellis platform, demonstrated statistically significant and superior back pain relief for patients compared to conventional SCS in a randomized controlled trial (RCT).3
 
The RCT revealed that at twelve months, 84% of patients with chronic back pain treated with DTM SCS reported at least 50% pain relief, compared to 51% of patients treated with conventional SCS, as measured by the Visual Analog Scale (VAS), a widely used and accepted measure for pain intensity.3 Fifty-percent pain relief, as measured by VAS, is a recognized industry standard to define minimum therapy success. At 12-months, 69% of patients reported profound pain relief of 80% or greater compared to 35.1% of patients treated with conventional SCS. The RCT results reported are from 128 patients who were randomized to either the treatment or control arm and 79 subjects who completed 12-month follow-up.3
 
In addition to offering DTM SCS therapy, the Intellis platform is a high-performance SCS device powered by proprietary Overdrive™ battery technology. It offers three times faster recharge than traditional battery choices and has minimal capacity fade at 9-years (less than 5%). It is optimized for a wide range of energy demands and provides effective long-term pain relief for patients. The neurostimulator features SureScan™ full-body MRI technology, allowing access to MRI anywhere in the body under certain conditions. The Intellis platform includes AdaptiveStim™ technology, which can automatically adjust stimulation to maintain therapy dose. Snapshot™ reporting, powered by the Intellis accelerometer and the smart clinician app, transform conversation from subjective to objective by monitoring and providing activity data. Physicians can review progress and make modifications to better suit their patients’ therapy needs.
 
“Chronic pain can affect people to the point that they can’t work, eat properly, take part in physical activity, or enjoy life. It can persist beyond the usual recovery period or occur along with a chronic health condition,” said Dr. Doshi. “While it can be challenging to manage chronic pain, attempt is made to reduce the severity of symptoms that come along. Treatment modalities like spinal cord stimulation can significantly improve the quality of life by alleviating pain. The Intellis platform is a welcome option to help optimize treatment and improve the outcome in these patients. It may also improve patient-physician communication by tracking and sharing activities, therapy usage and by giving physicians an objective look at treatment progress.”
 
“Spinal cord stimulation can be an effective alternative or adjunct treatment to other therapies that have failed to manage pain on their own. The Intellis neurostimulator is the world’s smallest implantable spinal cord stimulator. At Medtronic we are constantly designing life-transforming innovations that put patients first,” said Rahul Arora, head of Neurosciences Therapies, Medtronic India.
 
SCS is one of many therapy options available to treat chronic pain. It involves implanting a neurostimulator under the patients’ skin which delivers mild electrical impulses to the spine 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.4-8About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.
 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.
 

Saxena AK, Jain PN, Bhatnagar S. The Prevalence of Chronic Pain among Adults in India. Indian J Palliat Care. 2018 Oct-Dec;24(4):472-477. doi: 10.4103/IJPC.IJPC_141_18. PMID: 30410260; PMCID: PMC6199848.
Dureja GP, Jain PN, Shetty N, Mandal SP, Prabhoo R, Joshi M, Goswami S, Natarajan KB, Iyer R, Tanna DD, Ghosh P, Saxena A, Kadhe G, Phansalkar AA. Prevalence of chronic pain, impact on daily life, and treatment practices in India. Pain Pract. 2014 Feb;14(2):E51-62. doi: 10.1111/papr.12132. Epub 2013 Dec 4. PMID: 24304963.
Fishman M, Cordner H, et al. DTM™ SCS RCT 12-month Data Results. Presented at a Medtronic webinar, jointly supported by the North American Neuromodulation Society (NANS), World Institute of Pain (WIP), and the American Society for Pain and Neuroscience (ASPN). October 19, 2020. Webinar available on society websites.
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).
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).
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).
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).
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).

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*A workflow is guidance only and physicians should use their medical judgement and product labeling to optimize therapy for individual patients, which may require discontinuation or modification of a workflow.

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                        <p>Masooma Pathre, Public Relations, +91-9819744665

Ryan Weispfenning, Investor Relations, +1-763-505-4626

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Disclaimer: This Press Release has not been vetted or endorsed by The Eastern Herald's editorial staff.
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