Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 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. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Any circumstance where increased lymphatic or venous return is undesirable Material and methods Design and participants Keep in touch! I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /Filter /FlateDecode >> Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /Rotate 0 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I like to joke, Honey, time for me to put the squeeze on you And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. 11 0 obj I have skipped 1 or 2 days just 3 or 4 times since March. Lymphat Res Biol, 2016. Negative value shows a decrease in symptoms/problems. History of the Northwest Lymphedema Center. Filter by. I have one new for sale. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. /Group << My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 3701 Wayzata Blvd, Suite 300 /Font << No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. >> /Rotate 0 Yes, taking care of ones body requires several interventions. << Thanks. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Why Should I Register and Submit Results? Flexitouch Pd32-u Lymphedema Treatment System Pump. endobj /Annots [10 0 R 11 0 R 12 0 R] /S /URI A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 4. Support Care Cancer (2020). The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. << Toll-free: 1.833.3TACTILE (1.833.382.2845) stream Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] 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. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. I wish you success! Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. https://doi.org/10.1007/s00520-020-05540-8, 3. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. Thank you for sharing your husbands success with a pump. >> * American Society of Clinical Oncology 1. I can relate all too well to what you have been through. I didnt make a decision to purchase a pump that day. /Tabs /S Lymphedema I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. Your email address will not be published. Its something Im passionate about. I would suggest you keep contacting Tactile Medical. >> >> Venous Ulcers. I used it a few times and Im good now. >> by Flexitouch. >> 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. Learn how your comment data is processed. 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. /Version /1.4 /TT0 69 0 R Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. Hi Wally, Hope someone is able to meet your request. /StructParents 0 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. He just never could get use to using it and being able to don the garments. 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. between head and neck cancer and lymphedema. /Type /Action >> endobj Just wondering if you have any ideas of whom to contact on such a thing. /Type /Pages Please remove one or more studies before adding more. /Tabs /S /Type /Group /W 0 I was rather startled at how wrapped up I was. Ideas? Ive had my Flexitouch for almost five months. 46(4): 480487. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Do you know of anyone whom would want to buy it? Biomedical Optics Express. 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. /Subtype /Link 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. /MediaBox [0.0 0.0 612.0 792.0] Both Ease of Use/Satisfaction will be assessed by survey. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. First of all I cant drive, and second I have to pay a $60 copay every time I go. D/N500187-000-00 Rev. UGH! You have reached the maximum number of saved studies (100). /Tabs /S Head and chest measurements within the following: Prescribed the Flexitouch system or Flexitouch Plus, Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression), Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness), Symptomatic bradycardia in the absence of a pacemaker, Internal jugular venous thrombosis (within 3 months), Increased intracranial pressure or other contraindications to internal or external jugular venous compression, Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative, Facial or head and neck dermal metastasis, Acute facial infection (e.g., facial or parotid gland abscess), Any condition in which increased venous and lymphatic return is undesirable, Heart failure (acute pulmonary edema, decompensated acute heart failure), Subject is pregnant or trying to become pregnant, Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism). Negative value shows a decrease in swelling. /ProcSet [/PDF /Text /ImageC] endobj The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. 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. /F 4 Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. /TT3 72 0 R Choosing to participate in a study is an important personal decision. Support Care Cancer (2020). 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. Type of Use (Select one or both, as applicable) lXI . Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. /A << Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Search. Michelin Man came to mind as I stretched out on the couch. 1 0 obj endobj I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. endobj Managing my lymphedema requires attention and an assortment of tools. /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 have it in both of my legs mostly in my thighs. I?m 5? >> How customer reviews and ratings work See All Buying Options. According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. stream Talk with your doctor and family members or friends about deciding to join a study. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) endobj 2016;14(4):198205. Required fields are marked *. Hi Deborah, How wonderful you have had such positive success with your pump. I dont know if it will make a difference. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 3. 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. /Length 450 /Length 412 Sign up today for your free Reader Account. /TT2 72 0 R endobj . Its New, Your email address will not be published. /CS /DeviceRGB k (Note: There are other well regarded pumps on the market. Deng J, et al. endstream /Resources << XJ September 30, 2021 09:03 ET 14 0 obj /Type /Page 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. 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. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. /F 4 While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. 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 16 0 obj 2013; Vol. We rely on the generosity of individuals and sponsors who support our mission and activities. 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. Since using the Flexitouch for almost a year, she had not experienced cellulitis. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. >> It delivers a noninvasive therapy that patients can administer themselves at home. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. /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 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! Please cross your fingers for me that this works. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. 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. /Subtype /Link /Font << /ProcSet [/PDF /Text] In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Support Care Cancer (2020). 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^ 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. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? Reading or watching TV are the activities Im able to do while Im being treated. 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 the Flexitouch Plus device. Oral Oncology. /TT0 69 0 R 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. /Font << /Type /Group I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. /CropBox [0.0 0.0 612.0 792.0] 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional >> Actually they dont know much about lymphedema. Please remove one or more studies before adding more. /CS /DeviceRGB endobj Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. Positive value shows an increase in swelling. Breast cancer and treatment in itself was an awful journey. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. >> When I first went to physical therapy, she was running through some more common contibuters to swelling. Has anyone else had any experience with this? 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. Support Care Cancer (, 2020). /CropBox [0 0 612 792] >> /TT3 52 0 R /Length 585 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. 2008-2023 HMP Global, Inc. All rights reserved. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Learn More Take the steps now to help your head and neck cancer survivors. Adams, KE, Rasmussen JC, Darne C, et al. 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 It has made my life miserable. O ce they are used the government wont always them to use them on another. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs The whole process, though limiting my ambulation, was comfortable and relaxing. S Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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. Thank you for writing. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. >> /S /URI /Type /Page Out of my sleeve, my 3/4 length sleeves arent as tight. 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. 2. 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. 6 0 obj Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Positive value shows an decrease in quality of life. 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. Flexitouch . 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. Hope it works out. /TT1 70 0 R Lymphat Res Biol. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. 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 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. 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) This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. 7nwJ@6]?t~.} Heart failure (acute pulmonary edema, decompensated acute heart failure) /TT1 23 0 R /URI (http://www.fda.gov/) 12 0 obj Tens of thousands of. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Minneapolis, MN 55416 USA The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. 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. 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. 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 decided to purchase one without insurance. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. 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. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 1. Last updated March 2021. /StructParents 0 Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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