/StructParents 6 I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. How customer reviews and ratings work See All Buying Options. Any circumstance where increased lymphatic or venous return is undesirable https://doi.org/10.1007/s00520-020-. /CS /DeviceRGB Lymphedema 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. The lymphedema seen in patients treated for head . The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Hopefully it will give me a better quality of life because I dont know what else to do at this point. I didnt need a lymphedema physical therapist but too much to explain here. 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. /Tabs /S 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. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. D/N500187-000-00 Rev. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) /TT2 72 0 R Lymphat Res Biol. To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. 35 0 R] Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv 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. /Type /Action Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 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. /TT2 51 0 R >> /Parent 2 0 R /CropBox [0.0 0.0 612.0 792.0] Positive value shows an increase in pain. Flexitouch Plus - Treat Head & Neck Swelling At Home with This I like to joke, Honey, time for me to put the squeeze on you Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /Count 7 11 0 obj 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. /Rect [90.257 252.64 421.33 266.44] /TT2 71 0 R /Parent 2 0 R I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. >> Please write back in a month or so and let us know your progress. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. << Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Can I use the machine on lower limbs with compression garments above? Advanced Techniques in Canine and Feline Neurosurgery A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. 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. /Resources << Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. * American Society of Clinical Oncology 1. Another set of pads enveloped my left thigh and trunk. did you sell it yet? Explain the situation to them. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /Type /Catalog /Type /Page So for almost every night for the next seven years I sat down and performed MLD on my left arm. Choosing to participate in a study is an important personal decision. 2016;14(4):198205. /MediaBox [0.0 0.0 612.0 792.0] +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP 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. They are usually called something like 7 on your side or Channel 3 helps you. 9 0 obj Reading or watching TV are the activities Im able to do while Im being treated. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? 2010; Vol. endobj In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Chronic Wounds << /F 4 Keep sharing your story. Out of my sleeve, my 3/4 length sleeves arent as tight. A Registry to Evaluate the Flexitouch System and Flexitouch Plus for I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /MediaBox [0 0 612 792] /Type /Group The feeling of devloping a chronic disease after surviving cancer was almost debilitating. . Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. 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.. There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! S Thank you for writing. /CropBox [0.0 0.0 612.0 792.0] /Length 412 Tactile Systems Technology, Inc. 3701 Wayzata Blvd, Suite 300 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 had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. I decided to purchase one without insurance. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Yes. /C2_0 54 0 R /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] 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. Learn how your comment data is processed. Rz:MzI6 Do you know of anyone whom would want to buy it? 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 All reviewers. endobj Flexitouch Plus Lymphedema Treatment of the Head and Neck 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. So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. Biomedical Optics Express. 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. Michelin Man came to mind as I stretched out on the couch. 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. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Material and methods Design and participants EJVES. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Developing Lymphedema and not being able to get the help that I neededwas awful. Support Care Cancer (2020). Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Just wondering if you have any ideas of whom to contact on such a thing. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. Our Solutions for Head and Neck - Tactile Medical I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Phone: 1.612.355.5100 Try contacting different people. I cant explain that but I can visually see a difference. >> Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 & weigh 126 lbs. At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. /F 4 All stars. /S /Transparency The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. /TT0 69 0 R A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. Its brand new, used 1 time. Please cross your fingers for me that this works. 2013; Vol. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Last updated March 2021. endobj My Experience with the Flexitouch Pneumatic Pump for Lymphedema. [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. 2015;151(11):11871193. Thanks. The head & neck of non-human animals - /A << Flexitouch Plus provides flexible program options. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 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. 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. % Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Breast cancer and treatment in itself was an awful journey. >> endobj Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. I cannot find any shoes that fit my feet or any pants that fit comfortably . It was a blow to the life I had that I once had. where is the compassion for ill people that NEED certain healthcare to get better? 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 3. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. Tactile Systems debuts Flexitouch head and neck lymphedema treatment Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. /Type /Page 14(4): p. 198-205. Negative value shows a decrease in Function/Range of Motion. /ExtGState << Im only 44 years old , and I have kids that need mom back. . Since using the Flexitouch for almost a year, she had not experienced cellulitis. /ProcSet [/PDF /Text] 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. 2016;14(4):198205. Ridner, S.H., Dietrich, M.S., Deng, J. et al. << The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. Support Care Cancer (2020). 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. Hi Kathi, The FaceTime call might work! I would suggest you keep contacting Tactile Medical. << 3701 Wayzata Blvd, Suite 300 /CropBox [0.0 0.0 612.0 792.0] /TT0 69 0 R The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Type /Page /TT3 72 0 R Venous Ulcers. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. << Oral Oncology. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /StructParents 0 The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. /Tabs /S You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. >> /A << Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. It delivers a noninvasive therapy that patients can administer themselves at home. Negative value shows a decrease in quality of life/overall health. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Words like new kind of pump, different than the old types, favorable studies, and Dr. /Type /Pages Tactile Medical Announces Enrollment of First Patient in My lymphedema therapist also told me that the pumps werent worth it. << >> Choosing to participate in a study is an important personal decision. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. /CropBox [0 0 612 792] 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. >> If you still have the system, I am interested. 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. 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.