Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Breast cancer and treatment in itself was an awful journey. I have been having weekly physical therapy to help with lymphedema and range of motion issues. endstream In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. September 30, 2021 09:03 ET /Count 7 Another set of pads enveloped my left thigh and trunk. 2010; Vol. << Can I use the machine on lower limbs with compression garments above? Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. Negative value shows a decrease in Function/Range of Motion. It delivers a noninvasive therapy that patients can administer themselves at home. /Type /Action I still need to wear night garments and flat knit garmets and compression bras and self MLD but I feel like a weight has been lifted literally and physically. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /Parent 2 0 R The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. >> All stars. Material and methods Design and participants Managing my lymphedema requires attention and an assortment of tools. /TT1 50 0 R /Type /Group Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) (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. Heart failure (acute pulmonary edema, decompensated acute heart failure) /MediaBox [0 0 612 792] 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. 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. You have reached the maximum number of saved studies (100). I decided to purchase one without insurance. I dont know if it will make a difference. )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 1. >> What is encouraging is that you have had success with managing your lymphedema! Faculty Innovators: Sheila Ridner and Barbara Murphy spearhead trials Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. 4. I really need this system and had such desperate hope. The content is not intended to substitute manufacturer instructions. /TT1 23 0 R Thumbs up for Flexi-Touch!! 35 0 R] /Group << I was told purchased high priced left garments which I dont think I needed. /Rect [40.95 36 85.101 45.216] Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. endobj The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /Tabs /S >> /Rotate 0 Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. << 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. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 >> /ProcSet [/PDF /Text /ImageC] It delivers a noninvasive therapy that patients can administer themselves at home. 6 0 obj Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Tactile Medical Announces Enrollment of First Patient in I am looking for a left arm garment for the flexitouch plus. It was a blow to the life I had that I once had. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. tm233510-5_424b5 - none - 7.6719207s 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. >> endobj Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. >> Flexitouch . Words like new kind of pump, different than the old types, favorable studies, and Dr. /TT1 70 0 R 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. /TT0 69 0 R 17 0 obj HTo0~G6)BjH7u Phone: 1.612.355.5100 /C2_0 21 0 R endstream 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. 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. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. D/N500187-000-00 Rev. Positive value shows an decrease in quality of life. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Except for my wrist, all my measurements showed reduction. The Head & Neck Program is just 32 minutes long. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. /Font << Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /Im0 60 0 R Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. So we appealed 3 times. 1(1): 114125. /Type /Page 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 ] /Type /Catalog (Note: There are other well regarded pumps on the market. 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. Negative value shows a increase in quality of life. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. 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. 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. Biomedical Optics Express. /W 0 For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. 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. /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R 3 0 obj >> /F 4 >> I have a pump system left and right leg also stomach wraps. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 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 Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 3. Learn how your comment data is processed. I have one new for sale. endobj Please cross your fingers for me that this works. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) It has made my life miserable. During pregnancy (applies only to the Flexitouch Plus trunk accessory). 1. They only measured the circumference of my thighs and calfskin, not the length, so now I am STUCK with a non-refundable almost 9K system that is too long for me. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. >> Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. /Parent 2 0 R >> /Length 498 https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. 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 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. 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. /MediaBox [0.0 0.0 612.0 792.0] I did a baseline measurement of my left arm before treatment and three weeks after using the pump. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. [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. 11 0 obj /Type /Action 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. 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. 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. A healthy lymphatic system moves lymph fluid throughout the body. /Length 680 Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Hi Wandalynn . by Flexitouch. /Rect [40.95 36 85.101 45.216] Tactile Systems Technology, Inc. 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. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 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 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 will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. I would be interested to hear how your husbands experience with his new pump. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. My go to place when I need calming. The Flexitouch 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 . 2008-2023 HMP Global, Inc. All rights reserved. >> I only make 12k per year so its not like I can afford anything. 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. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. 0 T To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. << The lymphedema seen in patients treated for head . /CropBox [0 0 612 792] Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /TT3 72 0 R 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. Lymphat Res Biol. 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. >> Do you know of anyone whom would want to buy it? /CropBox [0.0 0.0 612.0 792.0] Looking at his ankles there IS no swelling now. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Text, image, video. They are usually called something like 7 on your side or Channel 3 helps you. Lymphat Res Biol, 2016. Why Should I Register and Submit Results? Minneapolis, MN 55416 USA /CS /DeviceRGB /A << Out of my sleeve, my 3/4 length sleeves arent as tight. >> 13 0 obj Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. did you sell it yet? Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Ml6(|a\!A.;Q#[. NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( Our Solutions for Head and Neck - Tactile Medical >> I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. 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. /Contents 73 0 R 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. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. Tactile Systems Technology (TCMD +0.6%) announces the enrollment of the first patient in a randomized, controlled trial evaluating the effectiveness of its Flexitouch Plus system for the treatment . 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.. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. /CropBox [0.0 0.0 612.0 792.0] I know many others can as well. 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. << Overview Product Features Details Benefits >> Try contacting different people. stream Subject overall health and quality of life in the past week-EORTC C30. 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. << H]O0+=) ES % The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. /TT0 23 0 R Phone: 1.612.355.5100 See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use >> /TT2 71 0 R Call us at 1.833.3TACTILE (1-833-382-2845), 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Listing a study does not mean it has been evaluated by the U.S. Federal Government. /TT0 69 0 R I chatted with a woman from Tacoma and another from Idaho. Pain will be assessed using the VAS Pain Scale. /TT2 72 0 R Flexitouch Plus provides flexible program options. Thanks. endobj Please remove one or more studies before adding more. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. 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. 2013; Vol. Learn More Take the steps now to help your head and neck cancer survivors. XJ 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. >> /Filter /FlateDecode /BS << While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. endobj 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. 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. /MediaBox [0.0 0.0 612.0 792.0] Phone: 1.612.355.5100 2015 51 (431-437), 1. I just received the flexitouch plus, but I think the leg garments are too big. The head & neck of non-human animals - | Cambridge SMART Vocabulary Its been tough . 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.