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Medtronic Intellis Scs

Non-opioid Therapies For Chronic Pain Spinal News International

Non-opioid Therapies For Chronic Pain Spinal News International

Non-opioid alternative for chronic pain approved in Europe Metronics Intellis platform, featuring (L to R) the wireless external neurostimulator, clinical programmer tablet, implantable neurostimulator, and patient programmer and recharger A Conformit Europene (CE) Mark has been received by Medtronic for its neurostimulation platform Intellis for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) in the treatment of non-opioid chronic pain, including low back pain, allowing the device to be marketed in Europe. Opioid abuse has reached critical levels globally, with US president Donald Trump last week declaring a public health emergency for the crisis, paving the way for federal funds to be redirected into opioid research and non-opioid pain management. Neurostimulation has shown positive results for managing chronic pain, with SCS providing effective long-term pain relief in some patients, and PNS resulting in relief from back pain and improvement in pain-related disability. SCS therapy uses a neurostimulator implant to deliver mild electrical impulses to the epidural space, acting to block pain signals from reaching the brain. Differently, PNS neurostimulators deliver mild electrical signals directly to the nerves at the site of pain, with the aim of interrupting pain signals to the brain. Chronic pain has been shown to affect all aspects of a persons life, including relationships, mental health, work productivity, and daily living, with an estimated one-fifth of Western Europeans suffering from the debilitating condition. Opioids, including extended release or long-acting (ER/LA) opioids such as morphine and methadone, and immediate release opioids such as fentanyl and oxycodone have long been used to treat chronic pain, including postoperatively, b Continue reading >>

Medtronic Enrolls First Patient In Pain Study To Assess Optimized Spinal Cord Stimulation Programming

Medtronic Enrolls First Patient In Pain Study To Assess Optimized Spinal Cord Stimulation Programming

Medtronic Enrolls First Patient In Pain Study to Assess Optimized Spinal Cord Stimulation Programming As More Physicians Seek Non-Opioid Treatment Options, the Vectors Study Will Further Advance Understanding of New Approaches to Optimal Spinal Cord Stimulation Treatment DUBLIN - January 9, 2018 - Medtronic plc (NYSE: MDT ) today announced the first patient enrolled in the Vectors Post Market Clinical Study. The study will follow patients with chronic intractable pain who are undergoing spinal cord stimulation (SCS) treatment managed with the EvolveSM workflow*, which standardizes guidance that balances high-dose (HD) and low-dose (LD) therapy settings to help physicians optimize treatment. Evolve runs on Medtronic SCS systems including Intellis(TM), the world's smallest implantable SCS neurostimulator, which recently received U.S. Food and Drug Administration and CE Mark approval. The first patient was enrolled by The Center for Interventional Pain & Spine in Wilmington, Delaware. "Our goal is to improve or restore function. Even with all of today's technological advances, chronic pain can be challenging to manage; this is further complicated by the opioid crisis," said Michael Fishman, M.D., from The Center for Interventional Pain & Spine. "Standard treatment guidance has the potential to help optimize pain relief, and the Vectors Post Market study will provide valuable data about the efficacy of high dose stimulation using standardized programming through the Evolve workflow." The Vectors study is a prospective, multi-center, post-marketing study that will enroll up to 175 patients with chronic intractable pain of the low back and legs at up to 25 sites in the U.S. The study will assess SCS's long-term efficacy and impact on quality of life and was designed to provi Continue reading >>

Fda Clears Medtronic's Next-generation Spinal Cord Stimulator

Fda Clears Medtronic's Next-generation Spinal Cord Stimulator

FDA clears Medtronic's next-generation spinal cord stimulator Medtronic's Intellis system provides 24/7 activity tracking, so physicians may see how well a neurostimulation program is treating a patient's chronic pain. (Michael Dorausch CC BY-SA 2.0) The FDA cleared Medtronic's latest spinal cord stimulation system for the treatment of chronic intractable pain. The world's smallest SCS, theIntellisdeviceoffers activity tracking and personalized pain relief. Designed to surmount limitations of current SCS devices, the Intellis platform comprises an implantable neurostimulator that records patient activity around the clock, a patient programmer and recharger. A physician manages the treatment on a Samsung tablet that allows the wireless programming of stimulation. "We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with theIntellisplatform," said Dr. Dave Rhew, chief medical officer and head of healthcare and fitness for Samsung Electronics America. "Samsung's Galaxy tablets-secured by the HIPAA-ready Samsung Knox mobile security platform-will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians usingIntellishave access to the most up-to-date solutions." Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. Continue reading >>

Fda Approves Advanced Spinal Cord Stimulator

Fda Approves Advanced Spinal Cord Stimulator

The U.S. Food and Drug Administration has approved a new spinal cord stimulator developed by Medtronic that can be managed, tracked and updated remotely on a Samsung Galaxy tablet. The Intellis stimulator is designed for patients with chronic, intractable pain of the trunk and/or limbs. The Intellis platform can track patient activity 24/7 on the Samsung Galaxy Tab S2 tablet, enabling physicians to personalize the settings for individual patients and monitor their progress using Medtronics Evolve software system. "The launch of the Intellis platform isn't just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief," said Marshall Stanton, MD, president of Medtronic's Pain Therapies division. The Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey - starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant." Spinal cord stimulators (SCS) are often considered the treatment of last resort for chronic back and leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain. Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain. New technologies are being developed to make the devices smaller, more effective and easier to recharge. Medtronic says Intellis is the world's smallest full Continue reading >>

Medtronic Wins Fda Nod For Intellis Scs, Launches In Us

Medtronic Wins Fda Nod For Intellis Scs, Launches In Us

Home Medtronic wins FDA nod for Intellis SCS, launches in US Medtronic wins FDA nod for Intellis SCS, launches in US Medtronic (NYSE: MDT ) said today it won FDA approval for its Intellis implantable spinal cord stimulation system and launched it in the US. The Fridley, Minn.-based company touted the newly revised system as the worlds smallest, and said that the new unit was designed to improve battery performance and standardize guidance and balancing of high-dose and low-dose therapy settings. Drawing upon our 40-year legacy in SCS, the launch of the Intellis platform isnt just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief. Medtronic is committed to addressing patient needs, so the Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant, Medtronic pain therapies division prez Dr. Marshall Stanton said in a press release. Medtronic said that the device is designed to interface with a Samsung Galaxy Tab S2 tablet interface to allow physicians to actively monitor and make modifications to the unit to meet patient needs. Chronic pain is challenging to manage. Having real-time data can provide more information about patients quality of life changes. This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse, Dr. Lance Roy of Duke University Medical Center, whi Continue reading >>

Intellis Platform Receives Ce Mark For Spinal Cord And Peripheral Nerve Stimulation

Intellis Platform Receives Ce Mark For Spinal Cord And Peripheral Nerve Stimulation

Intellis platform receives CE mark for spinal cord and peripheral nerve stimulation Medtronic has received CE mark for the Intellis platform for both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) as an aid in the management of certain types of chronic pain. According to Medtronic, Intellis, the worlds smallest fully implantable SCS neurostimulator, simplifies and improves the patient experience with improved battery performance that can power the Evolve workflow, which standardises 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 USA. One in five adults in Western Europe suffers from chronic pain, a devastating condition with a costly personal and societal impact. Chronic pain can negatively impact all aspects of a persons life relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated. 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. Similarly, PNS may also provide back pain relief, improvement in back pain-related disability, and reduce the need for pain medications. The potential benefits of neurostimulation are critical given the public health issue of prescription pain medication abuse. Earlier intervention with SCS has been shown to improve treatment outcomes and SCS is widely reimbursed and recommended by European governments. Current European guidelines support the use of SCS; failed back surgery sy Continue reading >>

Medtronic Intellis Implant

Medtronic Intellis Implant

Hi all - I had the new Medtronic Intellis SCS implanted a couple of weeks ago. This system was just launched earlier this month, so I'm probably one of the first patients to receive their latest technology. This is my second Medtronic SCS. The first was installed a couple of years ago, but failed a few months ago (turns out I had fractured both leads). I'm still early in my recovery, but the new system seems to be working okay. The Intellis rechargeable battery is much smaller than my old primary cell (non-rechargeable) battery, so is a lot more comfortable in my hip. The device rep was able to install my old programs on my new battery, although they then had to be modified to give me the same coverage due to the new lead placement.Unlike my old controller, the new controller is wireless, so I don't need to use an antenna to modify my settings. The new controller also has a touch screen, so the interface is a little more user friendly than the old system. I was a little worried about the added hassle of recharging, but so far this is not too bad. I'm recharging when I get down to 60-70% charge, which takes 15-20 minutes about every 3 days. Just wanted to share in case anybody else is looking at this system. Continue reading >>

Medtronic Receives Ce Mark For The World's Smallest Fully Implantable Spinal Cord Stimulator And Announces European Launch Of The Intellis Platform

Medtronic Receives Ce Mark For The World's Smallest Fully Implantable Spinal Cord Stimulator And Announces European Launch Of The Intellis Platform

Medtronic Receives CE Mark for the World's Smallest Fully Implantable Spinal Cord Stimulator and Announces European Launch of the Intellis Platform New Neurostimulation System Is a Non-Opioid Alternative for Chronic Pain and Offers Personalized Pain Relief and Advanced Activity Tracking DUBLIN - November 6, 2017 - Medtronic plc ( MDT ) today announced that it received CE (Conformit Europenne) 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 critic Continue reading >>

Spinal Cord Stimulation Archives - Neuronews International

Spinal Cord Stimulation Archives - Neuronews International

Spinal cord stimulation and chronic pain: In the end its about... Krishnan Chakravarthy writes in NeuroNews about how spinal cord stimulation can be used to treat chronic pain and how this can help America overcome... Shuffle stimulation improves pain scores in pilot study A pilot study published in Neuromodulation: Technology at the Neural Interface suggests that high frequency stimulation (HFS), an alternative SCS waveform could also be... Medtronic has a long-standing commitment to deliveringinnovative pain stimulation technology and building the evidencethat matters today and leads us into the future.This is again... WHISPER SCS study: therapy optimisation associated with more effective pain relief New data from the WHISPER randomised controlled trial (RCT) have demonstrated that patients who are given the choice to use both sub-perception and paraesthesia-based... Spectra WaveWriter Spinal Cord Stimulator System receives FDA approval The Spectra WaveWriter Spinal Cord Stimulator (SCS) System (Boston Scientific) has received FDA approval. It is the first and only system approved by the... FDA approves Senza II Spinal Cord Stimulation System The US Food and Drug Administration has approved the next-generation Senza II Spinal Cord Stimulation (SCS) System (Nevro) delivering HF10 therapy.According to the company,... First patient enrolled in study to assess optimised spinal cord stimulation... The first patient has been enrolled in the Vectors Post Market Clinical Study. The study will follow patients with chronic intractable pain who are... Nevro receives CE mark for full-body MRI conditional labelling with the... Nevro has received the CE mark for full-body magnetic resonance imaging (MRI) conditional labelling on the Senza Spinal Cord Stimulation (SCS) System deliv Continue reading >>

Medtronic Pain Management Device Approved By Fda Blogmedical Device Blog

Medtronic Pain Management Device Approved By Fda Blogmedical Device Blog

Medtronic Pain Management Device Approved by FDA Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to Medtronic, the Intellis platform features the worlds smallest implantable spinal cord stimulator (SCS), which includes an implantable pulse generator that looks like an older-style pacemaker, but with wire leads that delivers mild current to a spinal vertebra. The Intellis, and other SCS systems deliver, neurostimulation at the spinal cords to prevent pain signals from reaching the brain. The MIT Technology Review reports that SCS systems carry promise because they represent an alternative to opioid-based pain management. It is estimated that more than 20,000 Americans a year die from overdoses of prescription pain drugs. Government and industry alike recognize the gravity of the opioid issue. FDA Commissioner Dr. Scott Gottlieb has stated that opioid abuse is is taking a staggering human and economic toll and is therefore a top priority. Industries are also responding with ever-improving SCS systems (Medtronics pain-therapies business show $825 million in revenue during the companys 2017 fiscal year). According to Medtronic , the Intellis system allows physicians to better address the subjective and personal nature of patients chronic pain. Based on recorded and tracked patient activity, including body positions and how patients self-administer their therapy , Intellis allows a physician to program and manage pain therapy for each patient with a wirelessly connected Samsung tablet. Continue reading >>

Why Choose Medtronic?

Why Choose Medtronic?

Medtronic is the choice for chronic pain relief. Why Choose a Medtronic Spinal Cord Stimulation System? When making an important decision like choosing the best option for chronic pain relief, you want a company with experience. Medtronic developed neurostimulation therapy, and it was first approved in 1984.Choose technology that may benefit you into the future. The Medtronic Intellis platform offers: The worlds smallest implantable SCS neurostimulator AdaptiveStim technology that automatically adjusts stimulation as you change positions Safe access to MRI* scans anywhere on your body Approx. 1-hour battery recharge from empty to full Ability to recharge a completely discharged device More therapy options personalized to your pain Built-in activity tracking to help manage your therapy needs Storage of your treatment-related information and daily movement log in your Intellis device its with you wherever you go Discrete wireless trialing system lets you try SCS first Spinal Cord Stimulation Systems Are Not Alike Watch the video and discover important Medtronic differences like AdpativeStim technology and SureScan MRI technology. Medtronic Spinal Cord Stimulation Explained A simple explanation of AdaptiveStim technology and SureScan MRI Technology There are many resources available to help you get answers to your questions about Medtronic spinal cord stimulation. Continue reading >>

Medtronic's Intellis Spinal Cord Neurostimulation System Released In U.s. | Medgadget

Medtronic's Intellis Spinal Cord Neurostimulation System Released In U.s. | Medgadget

Medtronics Intellis Spinal Cord Neurostimulation System Released in U.S. Medtronic won FDA approval and is releasing in the U.S. itsIntellis spinal cord neurostimulation platform, which includes the worlds smallest fully implantable spinal cord neurostimulator. The system delivers both high-dose and low-dose therapy, depending on the patients needs, and tracks patient activity to help physicians improve how the therapy targets individuals pain. It is made to wirelessly, and securely, interface with a Samsung Galaxy Tab S2 tablet which is used by the physician to adjust settings and set parameters that best address the patients needs. The same tablet can be used to upgrade the neurostimulator implant with new versions of its firmware. One thing in particular that Medtronic touts is its Overdrive technology, which makes it a reality to recharge the implant from null to full in about an hour. Moreover, the Samsung tablet provides estimates of how long the device will last on a charge based on selected parameters combined with data gathered previously on the patients activity levels and pain reduction requirements. The implant is also safe to wear while inside an MRI machine, given certain conditions and as long as precautions are taken. Even full body scans are possible, so having the device does not limit the patients future diagnostic options. The company hopes that neurostimulation will have an impact on the opioid epidemic that the United States, as well as many other countries, is currently dealing with. Continue reading >>

Spinal Cord Stimulation Market Grows As Way To Treat Chronic Pain

Spinal Cord Stimulation Market Grows As Way To Treat Chronic Pain

Published 10:18 AM ET Thu, 29 March 2018 Connie Hanafy hikes with her daughter Marley. Hanafy was hardly able to walk until she received Medtronic's Intellis spinal cord stimulator. In less than a year, Connie Hanafy went from hiking and rollerskating with her daughters to hardly being able to walk. She had a benign tumor removed from her right leg in January 2017. For months after, she felt pain that didn't make sense. It wasn't typical post-procedure aches. It was a sharp, stabbing, throbbing and crushing feeling rolled up into one. "Before all of this happened, I was an extremely active person. I would hike all the time and was always doing things with my children," Hanafy said. "I was always outside and very outdoorsy. When this happened, it was a huge setback." The 32-year-old hospice worker from New Jersey was diagnosed with complex regional pain syndrome, a chronic condition that can develop after an injury or surgery. She tried treatments like steroid injections, nerve blocks and physical therapy, but the pain continued to worsen. Her only other option was opioid pain pills, but she refused to take them and risk slipping into addiction. By November, she just wanted her leg amputated. Dr. Youssef Josephson of The Pain Management Center in New Jersey suggested she try Intellis, a spinal cord stimulator. The device emits electrical pulses to help treat pain. The Food and Drug Administration had approved Intellis only a few months earlier. It's the latest system from Medtronic , the company that created the spinal cord stimulation market. It's one the medical device maker hopes will better help more patients and turn its performance in the category. Once the market leader, Medtronic ceded ground to rivals, just as the opioid epidemic was putting more focus on alter Continue reading >>

Intellis | Comprehensive Pain Specialists

Intellis | Comprehensive Pain Specialists

CPS is the first in nation to offer the new next generation Medtronic Spinal Cord Stimulator for long-term management of chronic pain Brentwood, Tenn. [Oct. 13, 2017] Comprehensive Pain Specialists (CPS) is the first and only in the country to offer the Intellis platform, including the worlds 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 persons life relationships, work productivity and activities of daily living, yet it remains under-recognized and undertreated.1 Given the national crisis involving opioid abuse, its more important than ever for patients suffering from chronic pain to have access to new non-opioid treatment options. At CPS, we are part of the solution, says Dr. Peter Kroll, chief executive officer and chief medical officer. We believe in responsible medication management and interventional modalities. There is no one-size-fits-all approach to managing pain. Its more important than ever for CPS to offer an effective, long-term, non-opioid solution; the availability of the Intellis spinal cord stimulator should offer new hope to patients struggling with debilitating pain. Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually 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 patients 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 re Continue reading >>

Newsroom | Medtronic | Rss Content

Newsroom | Medtronic | Rss Content

Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management The Intellis Platform Includes the World's Smallest Implantable Spinal Cord Stimulator and Offers Personalized Pain Relief and Advanced Activity Tracking DUBLIN - September 18, 2017 - Medtronic plc (NYSE:MDT) today announced FDA approval and U.S. launch of the Intellis(TM) platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the EvolveSM workflow*, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. The Intellis platform can record and track patient activity 24/7 and is managed on the Samsung Galaxy Tab S2 tablet interface, enabling physicians to address the subjective and personal nature of chronic pain by monitoring progress and making modifications to better suit their patients' therapy needs. Duke University Medical Center in Durham, N.C. implanted one of the first patients in the U.S. with the Intellis device. "Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Dr. Lance Roy, pain medicine specialist at Duke University Medical Center. "This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse." Back problems are one of the top 10 most expensive medical conditions, with an estimated 30 percent of the 300,000 patients annually that undergo lumbosacral spine procedures developing chronic intractable pain.1 Chronic pain can negative Continue reading >>

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