Summary of Safety and Effectiveness Data (Ssed)
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Microelectrode Implants for Spinal Cord Stimulation in Rats
Microelectrode Implants for Spinal Cord Stimulation in Rats Thesis by Mandheerej Singh Nandra In Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy California Institute of Technology Pasadena, California 2014 (Defended on Sept 24, 2014) ii © 2014 Mandheerej Nandra All Rights Reserved iii Acknowledgements First and foremost, I must express my most sincere gratitude towards my advisor, Prof. Yu-Chong Tai. Your depth of knowledge and sheer brilliance have guided and inspired me throughout my time at Caltech, and I will never forget your unwavering support for me through countless challenging times during this project, and the life lessons I have learned from you. It is truly my honor to be a part of your lab. This dissertation could only be achieved with the dedicated effort from the Edgerton lab at UCLA. I am grateful that Dr. Reggie Edgerton has given me this opportunity to join in the effort to push the boundaries of spinal cord research. I am forever in debt to the tireless work ethic of Parag Gad and Dr. Jaehoon Choe for their work with the animals used in this study and their concise analysis. I would like to thank my various colleagues through the years at the Caltech Micromachining Lab. None of the work in this thesis would be possible without Dr. Damien Rodger’s work in developing microelectrode fabrication technology at our lab. Dr. Angela Tooker and Dr. Wen Li were excellent mentors in teaching me all I needed to know in the lab. Thank you, Dr. Luca Giacchino and Dr. Ray Huang, for your friendship as we progressed through Caltech together. -
Precision™ Spinal Cord Stimulator System Clinician Manual Directions for Use
Precision™ Spinal Cord Stimulator System Clinician Manual Directions for Use 91083273-04 CAUTION: Federal law restricts this device to sale, Content: 92162683 REV A distribution and use by or on the order of a physician. Precision™ Spinal Cord Stimulator System Clinician Manual Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks All trademarks are the property of their respective holders. Clinician Manual 91083273-04 ii of iv Table of Contents Manual Overview ...........................................................................................................................1 Device and Product Description ..................................................................................................2 Implantable Pulse Generator ...........................................................................................................2 Leads ...............................................................................................................................................2 Lead Extension ................................................................................................................................2 Lead Splitter ......................................................................................................................................3 Indications for Use ........................................................................................................................4 -
Management of Chronic and Neuropathic Pain with 10 Khz Spinal Cord Stimulation Technology: Summary of Findings from Preclinical and Clinical Studies
biomedicines Review Management of Chronic and Neuropathic Pain with 10 kHz Spinal Cord Stimulation Technology: Summary of Findings from Preclinical and Clinical Studies Vinicius Tieppo Francio 1,* , Keith F. Polston 1 , Micheal T. Murphy 1 , Jonathan M. Hagedorn 2 and Dawood Sayed 3 1 Department of Rehabilitation Medicine, The University of Kansas Medical Center, Kansas City, KS 66160, USA; [email protected] (K.F.P.); [email protected] (M.T.M.) 2 Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN 55905, USA; [email protected] 3 Department of Anesthesiology, The University of Kansas Medical Center, Kansas City, KS 66160, USA; [email protected] * Correspondence: [email protected] Abstract: Since the inception of spinal cord stimulation (SCS) in 1967, the technology has evolved dramatically with important advancements in waveforms and frequencies. One such advance- ment is Nevro’s Senza® SCS System for HF10, which received Food and Drug and Administration (FDA) approval in 2015. Low-frequency SCS works by activating large-diameter Aβ fibers in the lateral discriminatory pathway (pain location, intensity, quality) at the dorsal column (DC), creating paresthesia-based stimulation at lower-frequencies (30–120 Hz), high-amplitude (3.5–8.5 mA), and µ Citation: Tieppo Francio, V.; Polston, longer-duration/pulse-width (100–500 s). In contrast, high-frequency 10 kHz SCS works with a K.F.; Murphy, M.T.; Hagedorn, J.M.; proposed different mechanism of action that is paresthesia-free with programming at a frequency Sayed, D. Management of Chronic of 10,000 Hz, low amplitude (1–5 mA), and short-duration/pulse-width (30 µS). -
About Pain Pharmacology: What Pain Physicians Should Know Kyung-Hoon Kim1, Hyo-Jung Seo1, Salahadin Abdi2, and Billy Huh2
Korean J Pain 2020;33(2):108-120 https://doi.org/10.3344/kjp.2020.33.2.108 pISSN 2005-9159 eISSN 2093-0569 Review Article All about pain pharmacology: what pain physicians should know Kyung-Hoon Kim1, Hyo-Jung Seo1, Salahadin Abdi2, and Billy Huh2 1Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University, Yangsan, Korea 2Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Received February 8, 2020 Revised March 12, 2020 From the perspective of the definition of pain, pain can be divided into emotional Accepted March 13, 2020 and sensory components, which originate from potential and actual tissue dam- age, respectively. The pharmacologic treatment of the emotional pain component Correspondence includes antianxiety drugs, antidepressants, and antipsychotics. The anti-anxiety Kyung-Hoon Kim drugs have anti-anxious, sedative, and somnolent effects. The antipsychotics are Department of Anesthesia and Pain effective in patients with positive symptoms of psychosis. On the other hand, the Medicine, Pusan National University sensory pain component can be divided into nociceptive and neuropathic pain. Yangsan Hospital, 20 Geumo-ro, Non-steroidal anti-inflammatory drugs (NSAIDs) and opioids are usually applied for Mulgeum-eup, Yangsan 50612, Korea Tel: +82-55-360-1422 somatic and visceral nociceptive pain, respectively; anticonvulsants and antide- Fax: +82-55-360-2149 pressants are administered for the treatment of neuropathic pain with positive and E-mail: [email protected] negative symptoms, respectively. The NSAIDs, which inhibit the cyclo-oxygenase pathway, exhibit anti-inflammatory, antipyretic, and analgesic effects; however, they have a therapeutic ceiling. -
Neuropathic Pain Case
Author Information Full Names: Erica Patel, MD Kiran V. Patel, MD Presenting Symptom: Burning in right foot> Chronic low back pain Case Specific Diagnosis: Chronic low back pain and radicular pain Learning Objectives: 1. To identify the factors affecting failure of trials (<50% pain reduction in pain for trial period). 2. Demonstrate ways to improve the success of spinal cord stimulation (SCS) trial. 3. Discuss and review literature on SCS efficacy in treating various chronic pain syndromes. History: A 75 year old female retired librarian with a past medical history of DM, and history of L5-S1 laminotomy/microdiscectomy ten years ago who presents with chronic low back pain and right burning foot pain for the past year. In the past six months the pain has increased in intensity. She denies any recent falls or trauma. She denies any bladder or bowel incontinence, weight loss, fever, chills or weakness of her lower extremities. She is interested in minimally invasive interventions to treat her pain and wants to avoid surgery if possible. The pain occurs daily and begins in the middle of the low back and travels to the sole of the right foot associated with a burning sensation. This pain is affecting her quality of life. She is unable to walk for more than 15 minutes due to the worsening back and leg pain. Her sleep is fragmented secondary to the burning in the right foot. Aggravating factors include bending, walking, and sitting. Alleviating factors include a TENS unit and rest. She follows with her primary regularly and states her “diabetes -
Pain Management Centre Spinal Cord Stimulator Pathway
Pain Management Centre Spinal Cord Stimulator Pathway Patient Information Leaflet for: Neuromodulation Pathway Author/s: K Dyer, B Roughsedge, G Daniels Author/s titles: Clinical Nurse Manager, Clinical Psychologist, Specialist Physiotherapist Approved by: Patient Information Forum Date approved: 03/01/2019 Review date: 03/01/2022 Available via Trust Docs Version: 7 Trust Docs ID:10179 Pain Management Centre Spinal Cord Stimulator (SCS) Pathway Your Consultant has suggested that you might be suitable for a trial of spinal cord stimulation (SCS). National Institute for Health and Clinical Excellence (NICE) guidelines for SCS state that “spinal cord stimulation should be provided only after an assessment by a multidisciplinary team experienced in chronic pain assessment and management of people with spinal cord stimulation devices, including experience in the provision of ongoing monitoring and support of the person assessed.” (NICE 2008). The multi-disciplinary team comprises Consultants, Specialist Nurses, Clinical Psychologists, Occupational Therapist & Specialist Physiotherapists, all who have many years’ experience of managing chronic pain with spinal cord stimulation. We have developed a pathway to comply with this guidance, which will start when the consultant recommends you for assessment by the spinal cord stimulator multidisciplinary team. The Pathway - what happens next? The first appointment in the pathway is a Technical Session. This is a group appointment and you are welcome to bring a relative/ friend with you. During this session we will: • Explain what spinal cord stimulation is • Demonstrate the types of equipment used • Discuss the risks associated with the device • Discuss the potential benefit you may receive from SCS • Discuss the trial and post op instructions if you proceed You will also be given an appointment with two members of the multi-disciplinary team. -
Spinal Cord Stimulation: a Nonopioid Alternative for Chronic Pain Management
PRACTICE | INNOVATIONS CPD Spinal cord stimulation: a nonopioid alternative for chronic pain management Aaron Hong MD MSc, Vishal Varshney MD, Gregory M.T. Hare MD PhD, C. David Mazer MD n Cite as: CMAJ 2020 October 19;192:E1264-7. doi: 10.1503/cmaj.200229 hronic pain affects 1 in 5 Canadians and is associated 1 with considerable socioeconomic burden. Although opi- KEY POINTS oids have been the mainstay of treatment, they have lost Spinal cord stimulation masks pain signals through a Cfavourability owing to crises of addiction, abuse, tolerance and • transcutaneous implantable electric pulse generator. dependence.1,2 Consequently, alternatives — including cognitive • Spinal cord stimulation is safe, efficacious and cost-effective in behavioural therapy, physical rehabilitation, non-opiate pharma- chronic pain management of neuropathic pain conditions, 1,3 cology and integrative therapies — have been developed. including failed back surgery syndrome, chronic regional pain When conventional therapies produce unacceptable adverse syndrome and chronic peripheral neuropathies. effects or do not provide sufficient pain relief, spinal cord • Newer spinal cord stimulation technologies are expanding stimulation (neuromodulation) may offer a rescue option, either clinical indications such as visceral and ischemic pain, with alone or in conjunction with other modalities.3,4 potential for further improved efficacy. Neuromodulation, defined as the alteration of nerve activity • Increased awareness of and access to spinal cord through targeted stimulus delivery, was first introduced in stimulation therapy may allow more Canadians to benefit 2,3,5 from relief of intractable chronic pain and may reduce 1967. It is based on the principle of electrically stimulating the opioid consumption. -
1. Summary of Safety and Effectiveness Data
1. Summary Of Safety And Effectiveness Data 1.1 General Information 1.1.1 Device Generic Name Totally Implanted Spinal Cord Stimulator for Pain Relief 1.1.2 Device Trade Name Genesis Neurostimulation (IPG) System 1.1.3 Applicant’s Name and Address Advanced Neuromodulation Systems (ANS), Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024 1.1.4 PMA Number P010032 1.1.5 Date of Notice of Approval to the Applicant November 21, 2001 1.2 Indications for Use ANS Genesis Neurostimulation (IPG) System 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 the following: failed back surgery syndrome, intractable low back and leg pain. 1.3 Device Description 1.3.1 Genesis Neurostimulation System The Genesis Neurostimulation (IPG) System consists of the following components: Model 3608 Implanted Pulse Generator (IPG), Model 3850 Patient Programmer, Model 1232 Programming Wand, and Model 1210 Patient Magnet. The Genesis Neurostimulation (IPG) System is intended to be used with the following ANS’ legally marketed components: · percutaneous lead models 3143, 3146, 3153, 3156, 3183 and 3186 · surgical lead models 3222, 3240, 3244 and 3280 · extension models 3382, 3383, 3341, 3342 and 3343 · ANS TS8 test stimulation system. The IPG is connected to a lead with four or eight electrodes, either directly or with a lead extension. The electrodes contact the patient along the spinal cord. The IPG is implanted in a subcutaneous pocket, and receives radio frequency (RF) programming signals from an external Patient 1 of 17 Programmer. -
Is Spinal Cord Stimulation an Effective Therapy to Treat Severe Lower
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Student Dissertations, Theses and Papers Scholarship 2018 Is spinal cord stimulation an effective therapy to treat severe lower extremity painful diabetic peripheral neuropathy that has lasted over one year and has not responded to medical therapy? Eleni Brecht Philadelphia College of Osteopathic Medicine Follow this and additional works at: https://digitalcommons.pcom.edu/pa_systematic_reviews Part of the Medicine and Health Sciences Commons Recommended Citation Brecht, Eleni, "Is spinal cord stimulation an effective therapy to treat severe lower extremity painful diabetic peripheral neuropathy that has lasted over one year and has not responded to medical therapy?" (2018). PCOM Physician Assistant Studies Student Scholarship. 357. https://digitalcommons.pcom.edu/pa_systematic_reviews/357 This Selective Evidence-Based Medicine Review is brought to you for free and open access by the Student Dissertations, Theses and Papers at DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Physician Assistant Studies Student Scholarship by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Is spinal cord stimulation an effective therapy to treat severe lower extremity painful diabetic peripheral neuropathy that has lasted over one year and has not responded to medical therapy? Eleni Brecht, PA-S A SELECTIVE EVIDENCE BASED MEDICINE REVIEW In Partial Fulfillment of the Requirements -
Neuropathic Pain: Treatment Yi Pan MD Phd ( Dr
Neuropathic pain: treatment Yi Pan MD PhD ( Dr. Pan of St. Louis University has no relevant financial relationships to disclose. ) Florian P Thomas MD MA PhD MS ( Dr. Thomas of Seton Hall-Hackensack Meridian School of Medicine and Hackensack University Medical Center has no relevant financial relationships to disclose. ) Louis H Weimer MD, editor. ( Dr. Weimer of Columbia University has received consulting fees from Roche.) Originally released August 31, 2001; last updated June 7, 2018; expires June 7, 2021 Introduction Overview Treatment of neuropathic pain is an ongoing challenge for clinicians. In this article, the authors summarize pharmacological management based on published clinical trials. Not all medications mentioned in this article have been investigated in placebo-controlled, double-blind, randomized trials. The aim of this article is to provide a variety of updated information so clinicians can choose an optimal treatment for an individual patient. Key points • Neuropathic pain is frequently treated with antidepressants, anticonvulsants, antiarrhythmics, topical agents, and analgesics. • The treatment must be individualized. • Combination of different agents should be considered in some patients. • Slow dose escalation may improve drug tolerability. Historical note and terminology Neuropathic pain results from injury to the central or peripheral nerve systems and is characterized by a neuronal hyperexcitability. Treatment of painful neuropathies has been a challenge to clinicians. Definitive clinical trials to evaluate the efficacy of pharmacological agents or other therapies require careful randomization of subjects representative of the relevant population, appropriate sample sizes, and an adequate number of reliable measurement scales. One of the challenges stems from the fact that placebo treatments are effective in a significant number of patients (Petersen et al 2012). -
Antidepressants for Neuropathic Pain (Review)
Antidepressants for neuropathic pain (Review) Saarto T, Wiffen PJ This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2007, Issue 4 http://www.thecochranelibrary.com Antidepressants for neuropathic pain (Review) Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 3 METHODS ...................................... 3 RESULTS....................................... 5 DISCUSSION ..................................... 11 AUTHORS’CONCLUSIONS . 12 ACKNOWLEDGEMENTS . 12 REFERENCES ..................................... 13 CHARACTERISTICSOFSTUDIES . 19 DATAANDANALYSES. 65 Analysis 1.1. Comparison 1 Global improvement - number of patients with moderate pain relief or better, Outcome 1 Amitriptylineversusplacebo. 67 Analysis 1.2. Comparison 1 Global improvement - number of patients with moderate pain relief or better, Outcome 2 Desipraminevsplacebo. 68 Analysis 1.3. Comparison 1 Global improvement - number of patients with moderate pain relief or better, Outcome 3 Imipraminevsplacebo. 68 Analysis 1.4. Comparison 1 Global improvement - number of patients with moderate pain relief or better, Outcome 4 Other antidepressants vs placebo. ..... 69 Analysis 1.5. Comparison 1 Global improvement - number of patients -
Intractable Pain Certification in the MN Medical Cannabis Program: a Primer for Health Care Practitioners
OFFICE OF MEDICAL CANNABIS Intractable Pain Certification in the MN Medical Cannabis Program: A Primer for Health Care Practitioners Contents Frequently Asked Questions ....................................................................................................... 2 Certification/ Recertification ...................................................................................................... 4 Surveys ........................................................................................................................................ 5 Patient Assessment and Management ....................................................................................... 5 Resources for Chronic Pain Assessment and Management ....................................................... 7 Resources for Medical Cannabis as a Component of Pain Management................................... 7 INTRACTABLE PAIN CERTIFICATION IN THE MN MEDICAL CANNABIS PROGRAM Frequently Asked Questions 1. What is the program’s definition of “intractable pain”? At time of certification (and recertification) the certifying health care practitioner must check a box indicating the following: “I certify that this patient has intractable pain. That is, this patient has pain whose cause cannot be removed and, according to generally accepted medical practice, the full range of pain management modalities appropriate for this patient has been used without adequate result or with intolerable side effects.” 2. Does the Office of Medical Cannabis require certain treatments for