Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. All stars. /Type /Page endobj Positive value shows an increase in swelling. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Phone: 1.612.355.5100 /Font << I have little confidence that the FaceTime call offered will be of much use. /Tabs /S Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. >> /TT2 58 0 R The pump has helped you achieve significant results. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /Tabs /S I have it in both of my legs mostly in my thighs. >> Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) 1. /CropBox [0.0 0.0 612.0 792.0] 3701 Wayzata Blvd, Suite 300 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. Subject Quality of Life will be assessed using EORTC C30 questionnaire. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. They are programed for each individual. I would be interested to hear how your husbands experience with his new pump. Breast cancer and treatment in itself was an awful journey. If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Except for my wrist, all my measurements showed reduction. Minneapolis, MN 55416 USA I dont know if it will make a difference. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I only make 12k per year so its not like I can afford anything. 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. stream I cant explain that but I can visually see a difference. I am looking for a left arm garment for the flexitouch plus. https://doi.org/10.1007/s00520-020-. Developing Lymphedema and not being able to get the help that I neededwas awful. Its something Im passionate about. Ridner, S.H., Dietrich, M.S., Deng, J. et al. The whole process, though limiting my ambulation, was comfortable and relaxing. 2 0 obj The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. 5 0 obj The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. >> Support Care Cancer (2020). Hopefully it will give me a better quality of life because I dont know what else to do at this point. Try contacting different people. 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. Overview Product Features Details Benefits & weigh 126 lbs. Learn More Take the steps now to help your head and neck cancer survivors. Phone: 1.612.355.5100 You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. >> A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Negative value shows a decrease in Function/Range of Motion. /TT0 49 0 R . In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 3701 Wayzata Blvd, Suite 300 Tens of thousands of. HTo0~G6)BjH7u Lymphedema Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 7nwJ@6]?t~.} /StructParents 0 >> 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. /Parent 2 0 R As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. /TT0 56 0 R We were asked to improve the ease of donning . /TT2 71 0 R This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. All subjects will receive a single intervention. [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. Please remove one or more studies before adding more. Refer to the Legal Notice for express terms of use. /Type /Group Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Numerous clinical studies show achievement of major clinical benefits and cost savings Deng J, et al. Rockson floated to my ears. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. endobj * American Society of Clinical Oncology 1. A healthy lymphatic system moves lymph fluid throughout the body. I would suggest you keep contacting Tactile Medical. /Group << /ProcSet [/PDF /Text] Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? I need help but theres a no return policy. >> 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. /Filter /FlateDecode Positive value shows an increase in symptoms/problems. | Source: First of all I cant drive, and second I have to pay a $60 copay every time I go. >> Faced with negative publicity, they often end up making things right. Support Care Cancer (, 2020). 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. Thumbs up for Flexi-Touch!! Hi Kathi, The FaceTime call might work! Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. To pump or not to pumpthat is a question that I hear in the lymphedema community. /Font << In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! 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. 46(4): 480487. /TT2 72 0 R Everything in my life that I do and love and I am passionate about invloves using my hands and arms. /Type /Action EJVES. You are benefiting the lymphedema community. Sort by. /CS /DeviceRGB 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 Wally, Hope someone is able to meet your request. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Medical Device Innovation | Nottingham Spirk Design Collaborative /Rect [40.95 36 85.101 45.216] 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. /Filter /FlateDecode 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. 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. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. 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. If anyone has one, or knows of one, please contact me. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Listing a study does not mean it has been evaluated by the U.S. Federal Government. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with 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/. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP 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. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. /S /URI Flexitouch Pd32-u Lymphedema Treatment System Pump /Subtype /Link During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. 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 have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. I have been suffering from lymphedema for the past 2 years. I have a pump system left and right leg also stomach wraps. Its been tough . The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. /Contents 73 0 R D/N500187-000-00 Rev. 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. I can relate all too well to what you have been through. << Im a pianist and its become my safe place. << 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. It delivers a noninvasive therapy that patients can administer themselves at home. Positive value shows an decrease in quality of life. I would contact your local news station that has a consumer investigation/help line.

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