The Trial phase of SCS have traditionally relied solely on patient feedback and if the device was on over the trial period to evaluate success or not. SmartLoop® Dose-Control Technology changes that. Last week, Dr. Dustin Reynolds, MD at OrthoNeuro in Ohio completed a trial with a patient who presented with low back and buttock pain. After two days, the patient reported only around 30% pain relief despite using the device continuously. Upon looking at the objective neural metrics, it was observed the neural dose was 1.2, meaning it was 20% above ECAP threshold which is below the published value of 1.4 that has shown to drive max pain relief. The patient’s neural dose was increased to 1.4 based on published data resulting in an increase in pain relief to 80% and the patient becoming a profound responder. Objective, Not Subjective. To read more about how to use neural metrics to drive max analgesic effect, visit our website at: https://lnkd.in/ei_jZJ7w To learn more about SmartLoop® technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z #KnowtheDose #ControltheDose #Biomarkerbaseddosing Individual results may vary Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
Saluda Medical
Medical Equipment Manufacturing
Bloomington, Minnesota 26,042 followers
The Evoke® System is now fully FDA approved
About us
Saluda Medical is a global company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies designed to treat debilitating neurological disorders. The company’s first product, the Evoke® System, is the only ECAP-controlled closed-loop spinal cord stimulation (SCS) system and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Evoke System instantaneously reads, records, and responds to the nerves’ response to stimulation to provide continually optimized therapy and is proven to be superior to open-loop SCS for the treatment of overall trunk and/or limb pain. 12-month results from the EVOKE Study, the first double-blind randomized controlled trial (RCT) used in support of Premarket Approval (PMA) in spinal cord stimulation history, were published in The Lancet Neurology and 24-month results have since been published JAMA Neurology. Both studies are poised to set new clinical standards for long-term pain relief and improvements in physical and emotional functioning, sleep quality and health-related quality of life. In the EU, Evoke is CE Marked and commercially available. In the U.S., Evoke is FDA-approved and will be available when the Company implements its full commercial release in 2023. Saluda Medical is a privately held company with headquarters in Bloomington, MN, USA. To learn more about Saluda Medical, including the risks & important safety information, visit www.saludamedical.com.
- Website
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http://www.saludamedical.com/
External link for Saluda Medical
- Industry
- Medical Equipment Manufacturing
- Company size
- 201-500 employees
- Headquarters
- Bloomington, Minnesota
- Type
- Privately Held
- Founded
- 2011
- Specialties
- Neuromodulation, Neuroscience, Closed-Loop Neuromodulation, Closed-Loop, Evoked Compound Action Potentials, ECAP, chronic pain, and Spinal Cord Stimulation
Locations
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Primary
9401 James Ave S
Suite 132
Bloomington, Minnesota 55431, US
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5 Eden Park Dr
Macquarie Park, New South Wales 2113, AU
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7 Alexandra Rd
Harrogate, North Yorkshire HG15JS, GB
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Bredaseweg 8
4844 CL
Terheijden, NL
Employees at Saluda Medical
Updates
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Recently published data has shown that each patient’s unique ECAP threshold can be used as a biomarker to objectively set the target neural dose to drive maximum pain relief. Last week, Dr. Derron Wilson, MD, FIPP at Goodman Campbell Brain and Spine completed an Evoke® SmartLoop® Trial on a patient who has been experiencing chronic bilateral back and leg pain since L4-L5 surgery in 2011. The patient presented with constant 10/10 pain and their goals for the trial were to walk, stand, sleep, and go camping again with less pain. On Day 0 of the trial, an ECAP and activation plot were captured, enabling an objective dose to be set of 48µV using the novel dose ratio metric of 1.4. The patient reported rapid onset of pain relief and by the end of the trial, the patient reported 100% pain relief and exceeded all of their goals and expectations. At the conclusion of a trial, only Saluda Medical provides a readout of objective neural metrics providing transparency and confidence in the SCS evaluation. To read more about how to use neural metrics to drive max analgesic effect, visit our website at: https://lnkd.in/ei_jZJ7w To learn more about SmartLoop® technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z #KnowtheDose #ControltheDose #BiomarkerbasedDosing Individual results may vary Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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How important is it to know the dose in SCS and be able to set this objectively for each of your patients? How important is it to control the dose and ensure tight adherence to the prescribed ECAP dose? This is what our esteemed faculty discussed with the attendees at our largest European SENSE Meeting to date last week in Cologne, Germany. For the first time, we can use the ECAP threshold as a biomarker to tailor each patient’s neural dose. By leveraging objective data from outside the clinic, we can optimize patient outcomes. SmartLoop™ Technology continuously adjusts with every pulse, maintaining strict adherence to the prescribed ECAP dose and ensuring consistent relief with every heartbeat, breath, and movement. Thank you to all our faculty and attendees for joining us in Cologne, and for your engagement and passion to ensure the best possible outcomes for your SCS patients. Faculty Prof. Dr. med. Rezvan Ahmadi Christian Wille @ Dr Bjorn Carsten Schultheis Priv.-Doz. Dr. Faycal El Majdoub Johan Van de Minkelis Prof. Dr. Jarek Maciaczyk @ Stefan Schu #KnowtheDose #ControltheDose Learn more about the Evoke® System, visit: https://lnkd.in/gX6abP8Z Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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How can neural metrics be utilized to objectively optimize SCS therapy? Recently, Dr. Chheany Ung, M.D. implanted a patient who presented with low back, hip and leg pain at Virginia Interventional Pain & Spine Centers in Roanoke, VA. The therapy was set to a target ECAP dose of 41 based on a calculated dose ratio of 1.4. The patient reports their pain score dropped from 9 down to a 1. To read more about how to use neural metrics to drive max analgesic effect, visit our website at: https://lnkd.in/ei_jZJ7w To learn more about SmartLoop® technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z Individual results may vary Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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Saluda Medical reposted this
Our latest analysis, Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements with ECAP Dose-Controlled Closed-Loop SCS, was just published in the Neuromodulation journal. For the first time, the analysis presents a prescription for the administration of SCS based on objective neurophysiological metrics to optimize SCS therapy and obtain maximum analgesic effect. To read the full publication, visit: https://lnkd.in/eDFCwzfw Robert Levy Peter Staats, MD, MBA Dan Brounstein Nagy Mekhail M.D. Ph.D. Christopher Gilmore, MD Leonardo Kapural, MD, PhD Erika PetersenJohnathan Goree Jason E. Pope, MD, DABPM, FIPP Jan Willem Kallewaard Simon Thomson Christopher Gilligan, M.D. Tariq AlFarra, DO Mustafa Broachwala, DO Harman Chopra, MD Corey Hunter Steven Rosen Kasra Amirdelfan Maged Guirguis Salim Hayek, MD, PhD Patrick Buchanan, M.D. Brian Bruel Ron Boeding Ajay Antony MD Aaron Calodney Dawood Sayed Rui Duarte Nandan Lad Sean Li, MD, FIPP Angela Leitner, MS Nicole Soliday Sherif Costandi, MD To learn more about SmartLoop® technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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Our latest analysis, Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements with ECAP Dose-Controlled Closed-Loop SCS, was just published in the Neuromodulation journal. For the first time, the analysis presents a prescription for the administration of SCS based on objective neurophysiological metrics to optimize SCS therapy and obtain maximum analgesic effect. To read the full publication, visit: https://lnkd.in/eDFCwzfw Robert Levy Peter Staats, MD, MBA Dan Brounstein Nagy Mekhail M.D. Ph.D. Christopher Gilmore, MD Leonardo Kapural, MD, PhD Erika PetersenJohnathan Goree Jason E. Pope, MD, DABPM, FIPP Jan Willem Kallewaard Simon Thomson Christopher Gilligan, M.D. Tariq AlFarra, DO Mustafa Broachwala, DO Harman Chopra, MD Corey Hunter Steven Rosen Kasra Amirdelfan Maged Guirguis Salim Hayek, MD, PhD Patrick Buchanan, M.D. Brian Bruel Ron Boeding Ajay Antony MD Aaron Calodney Dawood Sayed Rui Duarte Nandan Lad Sean Li, MD, FIPP Angela Leitner, MS Nicole Soliday Sherif Costandi, MD To learn more about SmartLoop® technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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Teamwork is vital to the success of any organization. Here at Saluda Medical, we recently held our field FOCUS week where the field team were joined by corporate and sales leaders to establish new connections, reinforce existing ones, and continue to build an industry leading team connection. #saludamedical #teamwork #focus #1degree To learn more about the opportunities here at Saluda Medical, visit: https://lnkd.in/gX6abP8Z
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Nurses play a crucial role in the care of neuromodulation patients in Europe and contribute significantly to the success of the therapy Recently, Ralph Aarsman from Albert Schweitzer Hospital in The Netherlands became an Evoke® System Master Programmer in Europe having completed all levels of the Saluda Medical nurse training program. “It is nice to finally be able to work with a neuromodulation system where you can observe objective data. This is an added value in the care of chronic pain patients. Previously neuromodulation was like a black box and we were unable to access crucial information; I now have a tool to provide our patients with better quality of care. This allows us to give the therapy in the right window.“ – Ralph Aarsman To learn more about SmartLoop™ dose-control technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z #KnowTheDose #ControlTheDose #DoseControl #ClosedLoop #TrueClosedLoop Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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Last weekend, we brought our global field team together to collaborate, celebrate, and focus on achieving our mission of revolutionizing neuromodulation! During the Global Sales Meeting, we launched training for the first biomarker-based dosing strategy in SCS. Following recent publications of chronic pain biomarker-based analyses, this is a giant step toward more objective treatment that creates a new level of consistency and confidence in SCS therapy. Special thank you to our 2 guest speakers- Dr. Johnathan Goree for sharing his insight on optimizing outcomes objectively with SmartLoop™ dose-control therapy and Doug Godshall, Chairman of the Board of Directors at Saluda Medical, for sharing his vision on Saluda’s game-changing technology. #KnowTheDose #ControltheDose #DoseControl Sean Talarico Tim Palmer James K. Eric Skoloff Tim Johnson, MBA #trueclosedloop #EVOKEStudy #Evoke #ECAPs #SmartLoop #SmartSCS #closedloop To learn more about the SmartLoop™ technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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At our recent SENSE Summit, Drs. Courtney Auman and Harjot S. Bhandal, MD led the discussion on integrating SmartLoop™ technology into your treatment continuum, clinical best practices, and how to leverage objective neural metrics to optimize outcomes. Thank you Dr. Auman and Dr. Bhandal for sharing your experience! To learn more about SmartLoop™ technology exclusively from Saluda Medical, visit: https://lnkd.in/gX6abP8Z Risks and Important Safety Info https://lnkd.in/d2XZ_Asn Rx Only The Saluda Medical Evoke® SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.