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Medtronics Tiny Neurostimulator Gets Ce Mark For Multiple Indications

Medtronics Tiny Neurostimulator Gets Ce Mark For Multiple Indications

Medtronics tiny neurostimulator gets CE mark for multiple indications Medtronic's Intellis system earned FDA clearance in September for spinal cord stimulation. Medtronics Intellis platform grabbed a CE mark for peripheral nerve and spinal cord stimulation. With the nod, the device is now cleared to treat chronic, intractable pain of the trunk, posterior trunk and limbs. The Intellis system, which earned the FDA green light in September, is the worlds smallest fully implantable spinal cord stimulation neurostimulator, the company said. The system includes the implant, a patient programmer and a recharger. A physician programs the therapy wirelessly, using a Samsung tablet. The device is designed to help physicians make better treatment decisions. In addition to delivering pain-relieving neurostimulation, it records patient activity, such as their body position and how they self-administer their treatment, around the clock. 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 >>

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 >>

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 >>

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 Gets Fda Clearance For Pain Management Implant That Interfaces With Samsung Tablet

Medtronic Gets Fda Clearance For Pain Management Implant That Interfaces With Samsung Tablet

Medtronic gets FDA clearance for pain management implant that interfaces with Samsung tablet Medtronic has received FDA clearance for a new implantable pain management device that can be programmed wirelessly via a Samsung tablet. The Intellis system is designed to treat chronic pain by delivering neurostimulation at the spinal cord. Using a Samsung Galaxy Tab S2, the patient's caregiver can adjust the neurostimulation according to a workflow designed by Medtronic called Evolve. "Drawing upon our 40-year legacy in [spinal cord stimulation], 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 Dr. Marshall Stanton, senior vice president and president of Medtronic's Pain Therapies division, said in a statement. "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." In addition to delivering neurostimulation, the implant also monitors the user's activity, which can help doctors determine the best course of treatment. "Chronic pain is challenging to manage," Dr. Lance Roy, a pain management specialist at Duke University Medical Center, where one of the first devices was implanted, said in a statement."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 trea 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 >>

Medtronic Rolls Out Latest Device To Treat Pain With Electricity

Medtronic Rolls Out Latest Device To Treat Pain With Electricity

Medtronic rolls out latest device to treat pain with electricity New device delivers current to block pain. With medical device companies across the nation hustling to find ways to treat pain without addictive opioid drugs, Medtronic is launching a system called the Intellis that uses electricity and can be securely controlled with a Samsung tablet. The Intellis is a latest-generation spinal-cord stimulation system that uses electric pulses to prevent pain signals from reaching the brain. The system was designed with features that address issues with older devices, including a new design that allows patients to fully recharge the device battery in one hour, and an interface that lets a doctor use a Samsung Galaxy S2 tablet to quickly adjust device settings and view past performance. "The Intellis platform was designed based on what is most important to patients and physicians," Dr. Marshall Stanton, president of Medtronic's pain therapies division, said in a news release. More than 20,000 Americans a year die from overdoses of prescription pain drugs, a toll that has shifted public attention toward ways of treating pain without creating addiction. Last May, Food and Drug Administration Commissioner Dr. Scott Gottlieb wrote online that his highest priority is to take immediate steps to reduce the scope of the opioid addiction epidemic. Implanted medical devices offer some promise in that regard, and a potentially large commercial market, but pain-relief devices also have their own drawbacks, including the need to charge batteries and the difficulty in adjusting device settings in response to subjective pain sensations. Medtronic competitor Abbott Laboratories, which acquired Minnesota-based St. Jude Medical and its line of devices to treat chronic pain in January, has w 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 >>

Fda Approves Medtronic's Intellis Scs - Spinal News International

Fda Approves Medtronic's Intellis Scs - Spinal News International

US FDA approves Medtronics Intellis spinal cord stimulation device The US Food and Drug Administration has approved Medtronics Intellis spinal cord stimulator. The company has now launched the product in the USA 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. It can power the Evolve workflow, which is intended to standardise guidance and balance 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. The company reports that this enables 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, USA, is one of the first centres to implant a US patient with the Intellis device. Chronic pain is challenging to manage. Having real-time data can provide more information about patients quality of life changes, says 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. Continue reading >>

Fda Approves Medtronic's Tablet-controlled Pain Device

Fda Approves Medtronic's Tablet-controlled Pain Device

FDA approves Medtronic's tablet-controlled pain device The Intellis system can be programmed via a Samsung's Galaxy S2 Medtronic has won US approval for, and launched, a pain management implant that can be remotely controlled by a Samsung tablet. The Intellis system treats chronic pain via neurostimulation, the level of which can be adjusted wirelessly by the Samsung Galaxy Tab S2. Marshall Stanton, president of Medtronic 's Pain Therapies division, said: "Drawing upon our 40-year legacy in SCS, the launch of the Intellis platform isn't just about a new device, but about combining cutting edge hardware with optimal therapy. Intellis is the world's smallest fully implantable SCS (spinal cord stimulation) neurostimulator and can also track daily activities, body positions and therapy usage to provide physicians with data on a patients mobility and progress. Dr Dave Rhew, chief medical officer and head of healthcare and fitness at Samsung Electronics America, said: "We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform. "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 using Intellis have access to the most up-to-date solutions." The two firms have previously worked together in diabetes , to develop a range of solutions to enhance management of the condition. Continue reading >>

Worlds Smallest Spine Stim Device Approved By Fda

Worlds Smallest Spine Stim Device Approved By Fda

Intellis Platform / Courtesy of Medtronic plc Worlds Smallest Spine Stim Device Approved by FDA Walter Eisner Thu, September 21st, 2017 Medtronic plc has received Supplemental PMA (premarket application) Approval from the FDA for the world's smallest implantable spinal cord stimulator. The announcement of the approval came on September 18, 2017. The company then also announced the U.S. launch of the Intellis platform for the management of certain types of "chronic intractable pain." The platform includes the stimulator. The platform, according to the company, was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance. The platform can also power the EvolveSM workflow, which standardizes guidance and balances high-dose (HD) and low-dose (LD) therapy settings. Patient activity can be recorded 24 hours a day. The platform is managed on the Samsung Galaxy Tax S2 tablet interface. This, says the company, allows physicians to address the "subjective and personal nature" of chronic pain by monitoring progress and making modifications. One of the first patients was implanted with the device at Duke University Medical Center in Durham, North Carolina. "Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality of life changes," said Lance Roy, M.D., pain medicine specialist at the 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." The company cites data estimating that 30% of the 300,000 patients annually that undergo lumbosacral spine procedures develop chronic intractable pain. Neurostimulation, added the company announceme Continue reading >>

Medtronic Gains Fda Approval Of Intellis Spinal Cord Stimulator For Chronic Pain Management

Medtronic Gains Fda Approval Of Intellis Spinal Cord Stimulator For Chronic Pain Management

Medtronic gains FDA approval of Intellis spinal cord stimulator for chronic pain management MedtroniconMondayannounced the FDA approval and US launch of the Intellis platform, which the company said includes the world's smallest implantable spinal cord stimulator (SCS), for the management of certain types of chronic intractable pain. Marshall Stanton, president ofMedtronic's pain therapiesdivision, explained thatin designing the next-generationspinal cord stimulator, the company "consideredthe 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." According to Medtronic, the Intellis platform is managed on the Samsung Galaxy Tab S2 tablet interfacetoallow physicians to monitor patient progress and make therapy modifications. The platform can continuously track and sharepatients'daily activities, body positions and therapy usage, andalsofeatures Overdrive battery technology, whichcanfully recharge the Intellis battery inabout one hour. Further, Medtronic said the platformincludesSureScan MRI technology, "which allows MRI scans anywhere on the body under certain conditions,"as well asAdaptiveStim technology "for automatic adjustments to deliver the right therapy dose to the right location, as the pain target shifts based on body position." Continue reading >>

Medtronic's Intellis Implantable Spinal Cord Stimulator Granted Ce Mark

Medtronic's Intellis Implantable Spinal Cord Stimulator Granted Ce Mark

Medtronic's Intellis Implantable Spinal Cord Stimulator Granted CE Mark Non-opioid alternative for chronic pain and offers personalized pain relief and advanced activity tracking. Intellis is the world's smallest fully implantable SCS neurostimulator. Image courtesy of Medtronic. European Interspinous Process Decompression Market to Surpass $30 Million by 2023 Medtronic plc announced that it 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.* Intellis, the world's smallest fully implantable SCS neurostimulator, simplifies and improves the patient experience with improved battery performance that can power the Evolveworkflow,** 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 liferelationships, 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.2Similarly, PNS may also provide back pain relief, improvement in back pain-related disability, and reduce the need for pain medications.3-4The potential benefits of neurostimulation are critica Continue reading >>

Fda Clears New Spinal Stimulation Device For Intractable Pain

Fda Clears New Spinal Stimulation Device For Intractable Pain

FDA Clears New Spinal Stimulation Device for Intractable Pain The US Food and Drug Administration (FDA) has approved the Intellis spinal cord stimulation platform (Medtronic) for the management of chronic, intractable pain of the trunk and/or limbs associated with a variety of conditions, the company has announced. The Intellis platform includes the world's smallest implantable spinal cord stimulator and offers personalized pain relief and advanced activity tracking, the company said in a news release. The Intellis platform can help optimize treatment and improve patient-physician communication by tracking and sharing daily activities, body positions, and therapy usage and by giving physicians an objective look at mobility and progress, the company said. "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 nonopioid treatment options are important, given the national crisis related to opioid abuse," Lance Roy, MD, pain medicine specialist at Duke University Medical Center, Durham, North Carolina, said in the release. One of the first implantation procedures in the United States using the Intellis platform was performed at Duke University Medical Center. The Intellis platform was designed to overcome limitations with current spinal cord stimulation systems, such as battery performance. The platform uses Medtronic's proprietary overdrive battery technology. The battery can be fully recharged from empty to full in about 1 hour, and physicians can now estimate recharge intervals on the basis of therapy settings. The platform also uses secure wireless clinician programmers managed on the Samsung Galaxy Tab 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 >>

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