/URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) 10 0 obj Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. /StructParent 1 /TT3 59 0 R >> With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. I knew Dr. Stanley Rockson of Stanford University was performing a drug trial with a medication called Uberimex for the treatment of lymphedema so I was keenly interested in learning what he said about this new pump. Negative value shows a decrease in swelling. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 5 0 obj >> It was up to me to piece it together. 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. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. ? between head and neck cancer and lymphedema. Thumbs up for Flexi-Touch!! For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /TT0 22 0 R Tactile Medical takes pride in the fact that our solutions help increase clinical efficacy, reduce overall healthcare costs and improve the quality of life for patients with chronic conditions. It delivers a noninvasive therapy that patients can administer themselves at home. I have skipped 1 or 2 days just 3 or 4 times since March. Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. PW!\v(jfz:yX 8$W"wqHbxQDL /Contents [13 0 R 14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R 20 0 R] I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. For more information, https://tactilemedical.com/about-us/. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. >> Many, many of my patients love their pump. /CS /DeviceRGB The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. << Then I got my flexitouch and my life changed. >> by Flexitouch. /W 0 I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . Hi Kristie, Thank you for sharing your story. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. /TT2 58 0 R Numerous clinical studies show achievement of major clinical benefits and cost savings 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 . /Parent 2 0 R /Type /Catalog 16 0 obj Percent change is calculated by the difference between scores averaged at 6 months versus baseline. phone: +1 (623) 738-9011 (57) Webstore 3. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ I decided to purchase one without insurance. trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. Its my new normal and Im thankful!! I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /TT1 23 0 R Percentage of each response captured. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. /Tabs /S 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. /MediaBox [0.0 0.0 612.0 792.0] /Type /Group >> stream >> The woman from Idaho said her arm was softer and found the machine easy to use. Minneapolis, MN 55416 USA The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Please remove one or more studies before adding more. /ProcSet [/PDF /Text /ImageC] /Length 412 Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. The Flexitouch Plus system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. The head & neck of non-human animals - | Cambridge SMART Vocabulary To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. did you sell it yet? << The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. (Clinical Trial). My husband has a brand new system that Im trying to sell. Please cross your fingers for me that this works. I can relate all too well to what you have been through. Try contacting different people. /Type /Page Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. /Contents 53 0 R As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. If you still have the system, I am interested. Positive value shows an increase in symptoms/problems. I have little confidence that the FaceTime call offered will be of much use. /Font << In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. 2016;14(4):198205. /TT3 52 0 R 8 0 obj When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. The lymphedema seen in patients treated for head . My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. /CropBox [0.0 0.0 612.0 792.0] /URI (http://www.fda.gov/) /TT1 70 0 R MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. https://doi.org/10.1007/s00520-020-. 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. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. I use it everyday for an hour. 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. For general information, Learn About Clinical Studies. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! I use it every evening. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. /Length 498 See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use /CS /DeviceRGB stream /A << I have been having weekly physical therapy to help with lymphedema and range of motion issues. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? /Length 680 My insurance company required me to use a different brand of compression pump and experience failure before they would consider covering the cost of a Flexitouch. endobj [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. /Contents 36 0 R Its been tough . H]O0+=) ES It delivers a noninvasive therapy that patients can administer themselves at home. >> Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /Font << 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. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. The content is not intended to substitute manufacturer instructions. /Version /1.4 /CropBox [0 0 612 792] endobj Faced with negative publicity, they often end up making things right. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. How customer reviews and ratings work See All Buying Options. I am looking for a left arm garment for the flexitouch plus. /Type /Page Breast cancer and treatment in itself was an awful journey. 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. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. >> When she said piano I froze. I need help but theres a no return policy. The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. /BS << Ive had my Flexitouch for almost five months. << What is encouraging is that you have had success with managing your lymphedema! Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Tactile Systems Technology, Inc. /Font << But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. Talk with your doctor and family members or friends about deciding to join a study. Sign up today for your free Reader Account. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. Tens of thousands of. /F 4 If Im out late, I use it in the morning and then resume again in the evening. /Rotate 0 Ridner, S.H., Dietrich, M.S., Deng, J. et al. /CropBox [0.0 0.0 612.0 792.0] Except for my wrist, all my measurements showed reduction. Flexitouch Plus provides flexible program options. Im only 44 years old , and I have kids that need mom back. Venous Ulcers. 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. 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. /C2_0 54 0 R Last updated March 2021. Rz:MzI6 Since using the Flexitouch for almost a year, she had not experienced cellulitis. More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Material and methods Design and participants Thank you for sharing and being an advocate for lymphedema! endobj Hi Karyn, I will post your comment and see if Sarah still has the pump available. I wish you success! September 30, 2021 09:03 ET 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. I have one new for sale. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Lymphat Res Biol, 2016. Deng J, et al. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. Sort by. >> >> Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? /StructParents 0 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. 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. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. /Type /Group Has anyone else had any experience with this? 1(1): 114125. I know many others can as well. 46(4): 480487. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. For more information, https://tactilemedical.com/about-us/. 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. The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. /Length 585 Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /Subtype /Link HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Having to search it all out including bandaging and reducing myself, learning from You Tube, finding supplies online and dealing with physical therapists and oncologists and radiation oncologists who dont know anything about this chronic disease and putting all the pieces together myself because there are people to help but no one knows where they are was emotially depressing. /Font << Ridner, S.H., Dietrich, M.S., Deng, J. et al. The Flexitouch System is not used for nor intended for use to treat cellulitis. /F 4 endobj >> Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) I just received it yesterday and Im super hopeful that it will help. 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. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. endobj It has made my life miserable. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. << EJVES. >> /URI (http://www.fda.gov/) My go to place when I need calming. Search. Adams, KE, Rasmussen JC, Darne C, et al. 3701 Wayzata Blvd, Suite 300 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. It was a blow to the life I had that I once had. Flexitouch . (Note: There are other well regarded pumps on the market. I would suggest you keep contacting Tactile Medical. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Toll-free: 1.833.3TACTILE (1.833.382.2845) Negative value shows a decrease in quality of life/overall health. Tens of thousands of. I cant explain that but I can visually see a difference. The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. << Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. Both Ease of Use/Satisfaction will be assessed by survey. My insurance paid for all of it and the Tactile rep will help you get that. Ive heard from many people that they saw good results with their pump. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. I was rather startled at how wrapped up I was. /ProcSet [/PDF /Text] Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) >> Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional /TT0 56 0 R We were asked to improve the ease of donning . Deng J, et al. Choosing to participate in a study is an important personal decision. I like to joke, Honey, time for me to put the squeeze on you https://doi.org/10.1007/s00520-020-05540-8, 3. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? 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. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). (6Kjw_XGz'g &p I?m 5? Negative value shows a decrease in Function/Range of Motion. The chambers take turns filling up with air with the goal of moving excess fluid out of the affected limb and returning it to the cardiovascular system. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. << Percent change is calculated by the difference between scores averaged at 6 months versus baseline. You are benefiting the lymphedema community. /StructParents 6 Out of my sleeve, my 3/4 length sleeves arent as tight. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. They are usually called something like 7 on your side or Channel 3 helps you. They are in contact with patients who could benefit from a pneumatic pump. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /Resources << All reviewers. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! /Type /Pages Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /C2_1 55 0 R The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Learn how your comment data is processed. Can I use the machine on lower limbs with compression garments above? Chronic Wounds >> Support Care Cancer (2020). Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 /MediaBox [0.0 0.0 612.0 792.0] Hopefully it will give me a better quality of life because I dont know what else to do at this point. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Text, image, video. 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. >> /Rotate 0 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.
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