The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /BS << The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. I had a mastectomy and 9 lymph nodes removed 3 months ago. I wonder if pumps can be reprogrammed. /A << Ridner, S.H., Dietrich, M.S., Deng, J. et al. Has anyone else had any experience with this? It was up to me to piece it together. /Version /1.4 << It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. O ce they are used the government wont always them to use them on another. I just received it yesterday and Im super hopeful that it will help. 2008-2023 HMP Global, Inc. All rights reserved. /Rect [40.95 36 85.101 45.216] HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ doi.org/10.1007 /s00520-020-05540-8, First-ever randomized control trial of home management of head and neck lymphedema, Retrospective analysis of 205 Flexitouch user survey responses, Near-infrared fluorescence lymphatic imaging (NIRFLI) before and after Flexitouch use, Flexitouch Plus is the only FDA cleared pneumatic, See the clinical benefit of Flexitouch Plus, Longitudinal Patient Reported Outcomes Study. Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. . Yes, taking care of ones body requires several interventions. I use it every evening. Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. Ive heard from many people that they saw good results with their pump. I use it everyday for an hour. Both Ease of Use/Satisfaction will be assessed by survey. Words like new kind of pump, different than the old types, favorable studies, and Dr. The content is not intended to substitute manufacturer instructions. Heart failure (acute pulmonary edema, decompensated acute heart failure) /TT3 59 0 R 1. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. My husband?s pump system arrived yesterday. 2016;14(4):198205. /Resources << endobj D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. ? Information provided by (Responsible Party): The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) I only make 12k per year so its not like I can afford anything. . /Im0 24 0 R /Type /Group I know many others can as well. /MediaBox [0 0 612 792] Its New, Your email address will not be published. I didnt make a decision to purchase a pump that day. Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. Thumbs up for Flexi-Touch!! /Contents 36 0 R The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. 1 0 obj /Filter /FlateDecode Sign up today for your free Reader Account. /ProcSet [/PDF /Text] Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional endstream They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. Free shipping for many products! >> /ProcSet [/PDF /Text /ImageC] Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. /Resources << The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. >> Minneapolis, MN 55416 USA 4? where is the compassion for ill people that NEED certain healthcare to get better? The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Companys control that can make such statements untrue, including, but not limited to, the impacts of the COVID-19 pandemic on the Companys business, financial condition and results of operations; the course of the COVID-19 pandemic and its impact on general economic, business and market conditions; the Companys inability to execute on its plans to respond to the COVID-19 pandemic; the adequacy of the Companys liquidity to pursue its business objectives; the Companys ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives, including prior to identifying a successor; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Companys products; technical problems with the Companys research and products; the Companys ability to expand its business through strategic acquisitions; the Companys ability to integrate acquisitions and related businesses; price increases for supplies and components; the effects of current and future U.S. and foreign trade policy and tariff actions; or the inability to carry out research, development and commercialization plans. It delivers a noninvasive therapy that patients can administer themselves at home. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Talk with your doctor and family members or friends about deciding to join a study. JAMA Dermatol. 1(1): 114125. /Filter /FlateDecode The leg garments that I received are for a much taller person. Type of Use (Select one or both, as applicable) lXI . When I called my surgeon, he recommended that I not use the FlexiTouch on my chest because the compression can make the tissue expander rupture. /URI (http://www.fda.gov/) 8 0 obj Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Rotate 0 I didnt need a lymphedema physical therapist but too much to explain here. 4 0 obj For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /Type /Group /CropBox [0 0 612 792] 14(4): p. 198-205, 2. Actually they dont know much about lymphedema. /Filter /FlateDecode HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. PW!\v(jfz:yX 8$W"wqHbxQDL Please cross your fingers for me that this works. /MediaBox [0 0 612 792] Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. For general information, Learn About Clinical Studies. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Choosing to participate in a study is an important personal decision. I can relate all too well to what you have been through. >> Michelin Man came to mind as I stretched out on the couch. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). /MediaBox [0.0 0.0 612.0 792.0] It takes just 32 minutes per day. Hi Karyn, I will post your comment and see if Sarah still has the pump available. >> Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. The pump has helped you achieve significant results. I have a uniboot compressions on both of my calves. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /S /URI I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. /Type /Page /TT3 72 0 R endobj /Font << 5 0 obj The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! EJVES. Rockson floated to my ears. The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. Deng J, et al. Thank you for sharing and being an advocate for lymphedema! Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? k I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. stream Why Should I Register and Submit Results? My insurance paid for all of it and the Tactile rep will help you get that. For more information, https://tactilemedical.com/about-us/. I would suggest you keep contacting Tactile Medical. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. During pregnancy (applies only to the Flexitouch Plus trunk accessory). /S /Transparency 3 0 obj This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. << /Type /Catalog x Im only 44 years old , and I have kids that need mom back. Developing Lymphedema and not being able to get the help that I neededwas awful. It delivers a noninvasive therapy that patients can administer themselves at home. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. Required fields are marked *. /Rotate 0 I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump. They are usually called something like 7 on your side or Channel 3 helps you. 7nwJ@6]?t~.} Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. /Parent 2 0 R I have it in both of my legs mostly in my thighs. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 >> I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Ml6(|a\!A.;Q#[. endobj /W 0 The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. /CS /DeviceRGB /W 0 >> document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /Type /Group I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /S /Transparency >> The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. My husband has a brand new system that Im trying to sell. << /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) Please remove one or more studies before adding more. My interest in pumps suddenly skyrocketed! Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /TT0 69 0 R Many, many of my patients love their pump. * American Society of Clinical Oncology 1. I dont know if it will make a difference. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp /TT1 23 0 R It delivers a noninvasive therapy that patients can administer themselves at home. /C2_0 54 0 R Please remove one or more studies before adding more. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Support Care Cancer (, 2020). /CropBox [0.0 0.0 612.0 792.0] !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Support Care Cancer (2020). Text, image, video. Ive had my Flexitouch for almost five months. To pump or not to pumpthat is a question that I hear in the lymphedema community. Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. /URI (http://www.fda.gov/) /StructParents 0 /CropBox [0 0 612 792] >> << /Group << /TT0 56 0 R Negative value shows a decrease in symptoms/problems. % To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Another set of pads enveloped my left thigh and trunk. I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). It was a blow to the life I had that I once had. /Annots [39 0 R] D/N500187-000-00 Rev. 11 0 obj To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. << Thanks. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Try contacting different people. 2013; Vol. /Type /Action by Flexitouch. /Parent 2 0 R endobj Ive always been diligent about caring for my lymphedema but if there was a product that could further the health of my left arm, I was going to investigate. >> << I greatly encourage others to try to obtain one if they are able and if it is a good option for them. The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. /Tabs /S Percent change is calculated by the difference between scores averaged at 6 months versus baseline. >> Hi Kristie, Thank you for sharing your story. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. Chronic Wounds bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. I have one new for sale. /Type /Action Managing my lymphedema requires attention and an assortment of tools. between head and neck cancer and lymphedema. (Therapists couldnt afford themselves to take insurance payments because most insurances do not reinburse them enough to make it worthwhile) All in all I finally found the Lymphedema Center (why dont doctors know this) and took some classes and found an amazing therapist who has helped and has been trained in lymphedema and a few massage therapists that know what they are doing and are trained. /Filter /FlateDecode Its my new normal and Im thankful!! Study record managers: refer to the Data Element Definitions if submitting registration or results information. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. I would contact your local news station that has a consumer investigation/help line. /Tabs /S Of the patients who tried the device, 88% saw a reduction in head and neck swelling after an initial 32-minute at-home treatment with the Flexitouch system, and 89% of patients reported. Tactile Systems Technology, Inc. So for almost every night for the next seven years I sat down and performed MLD on my left arm. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. >> Its amazing to me how little doctors know about lymphedema. Ridner, S.H., Dietrich, M.S., Deng, J. et al. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. I always start with the one hour full arm and core setting. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation. She explained that compression pumps force air into sleeves with multiple chambers. 1. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016.