https://doi.org/10.1007/s00520-020-05540-8, 3. I just came across this site about the Flexitouch Pneumatic Pump for 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /TT1 57 0 R Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. Breast cancer and treatment in itself was an awful journey. They use them in the morning, at nightand feel very lucky.. & weigh 126 lbs. Im a pianist and its become my safe place. ? FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. >> /TT0 23 0 R I wonder if pumps can be reprogrammed. I just received the flexitouch plus, but I think the leg garments are too big. I have it in both of my legs mostly in my thighs. /Tabs /S Positive value shows an increase in swelling. S 13 0 obj /Length 412 Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Minneapolis, MN 55416 USA 2. Clinical Trial on Head and Neck Cancer: Flexitouch Plus system >> Has anyone else had any experience with this? endobj /W 0 Flexitouch Pd32-u Lymphedema Treatment System Pump. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N stream 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. 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. K-ZB: The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. The leg garments that I received are for a much taller person. /MediaBox [0 0 612 792] The warranty was the same as a new machine. Since using the Flexitouch for almost a year, she had not experienced cellulitis. All stars. So for almost every night for the next seven years I sat down and performed MLD on my left arm. 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. endobj HQK0)I46IC">bY3oons} K.4V./`\f0 Fs I decided to purchase one without insurance. 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 /URI (http://www.fda.gov/) >> /C2_0 48 0 R /S /URI Ridner, S.H., Dietrich, M.S., Deng, J. et al. /S /Transparency 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). 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. /Resources << Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. Just wondering if you have any ideas of whom to contact on such a thing. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Required fields are marked *. Lymphat Res Biol. 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. stream So we appealed 3 times. 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. Flexitouch Plus Lymphedema Treatment of the Head and Neck The Flexitouch System is not used for nor intended for use to treat cellulitis. did you sell it yet? HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ Its also a relief not to manually MLD my arm every night. Advanced pneumatic compression for treatment of lymphedema of the head /GS0 37 0 R >> PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and >> Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /TT1 70 0 R >> Both Ease of Use/Satisfaction will be assessed by survey. Flexitouch Plus provides flexible program options. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. D/N500187-000-00 Rev. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. 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 a uniboot compressions on both of my calves. 16 0 obj 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. Hi Jaime, Im hopeful that your new pump will provide relief. JAMA Dermatol. HTo0~G6)BjH7u Sort by. Lymphat Res Biol. * American Society of Clinical Oncology 1. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. x I have lymphedema in my right arm, breast and axilla. Of the patients who tried the device, 88% saw a reduction in head and neck swelling after an initial 32-minute at-home treatment with the Flexitouch system, and 89% of patients reported. 2008-2023 HMP Global, Inc. All rights reserved. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /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] Flexitouch Plus - Applying the Head and Neck Garment Set I would suggest you keep contacting Tactile Medical. Lymphedema PW!\v(jfz:yX 8$W"wqHbxQDL It has made my life miserable. 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. This is not anadvertisement for Flexitouch.). Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /Length 450 2010; Vol. >> In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. /Rotate 0 endobj Negative value shows a decrease in quality of life/overall health. /StructParents 0 Negative value shows a increase in quality of life. /Contents 36 0 R }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Chronic Wounds The feeling of devloping a chronic disease after surviving cancer was almost debilitating. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. 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. Hi Deborah, How wonderful you have had such positive success with your pump. /Type /Page Support Care Cancer (, 2020). /TT3 74 0 R 2. I dont like that I have to do it but it has changed my legs back to normal. endobj /MediaBox [0.0 0.0 612.0 792.0] 3 total ratings, 2 with reviews There was a problem filtering reviews right now. H]O0+=) ES I have a pump system left and right leg also stomach wraps. Negative value shows a decrease in symptoms/problems. Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. k >> << 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, 3701 Wayzata Blvd, Suite 300 Choosing to participate in a study is an important personal decision. /CropBox [0 0 612 792] Toll-free: 1.833.3TACTILE (1.833.382.2845) /StructParents 0 /TT2 51 0 R >> To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. For more information, https://tactilemedical.com/about-us/. For general information, Learn About Clinical Studies. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /S /URI /Filter /FlateDecode 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/. I have skipped 1 or 2 days just 3 or 4 times since March. endobj It was up to me to piece it together. EJVES. 1. /Resources << >> I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). Subject overall health and quality of life in the past week-EORTC C30. Biomedical Optics Express. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! 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 News Release Details - Tactile Systems Technology, Inc. /F 4 Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. The woman from Idaho said her arm was softer and found the machine easy to use. 12 0 obj 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. Why Should I Register and Submit Results? 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) /Contents 75 0 R Deng J, et al. 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 bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Hi Kathi, The FaceTime call might work! The pump is called the Flexitouch System by Tactile Medical. 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. | Source: Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. 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. 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. endobj 1 0 obj The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. >> /TT1 23 0 R Last updated March 2021. [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. A Registry to Evaluate the Flexitouch System and Flexitouch Plus for I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 5 0 obj Refer to the Legal Notice for express terms of use. Its my new normal and Im thankful!! >> 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. Type of Use (Select one or both, as applicable) lXI . It delivers a noninvasive therapy that patients can administer themselves at home. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. 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. 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. Flexitouch Plus - Treat Head & Neck Swelling At Home with This 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. Tactile Medical braces for new Medicare rules that will tighten access 2013; Vol. Learn More Take the steps now to help your head and neck cancer survivors. Ive heard from many people that they saw good results with their pump. Learn how your comment data is processed. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. 35 0 R] Im only 44 years old , and I have kids that need mom back. << To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. /BS << Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. >> endobj The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 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/. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. 4 0 obj /Tabs /S Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. /Font << Advanced Techniques in Canine and Feline Neurosurgery /Parent 2 0 R I use it every evening. << 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 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. /TT0 69 0 R I was rather startled at how wrapped up I was. Medical Device Innovation | Nottingham Spirk Design Collaborative Thank you for sharing your husbands success with a pump. /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 Positive value shows an increase in Function/Range of Motion. Lymphedema Treatment in Head and Neck Cancer Patients One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. /MediaBox [0.0 0.0 612.0 792.0] Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /Resources << /Rect [40.95 36 85.101 45.216] Rz:MzI6 /Type /Pages /TT0 22 0 R >> Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Lymphedema - Head and Neck Cancer Alliance << Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. << Filter by. Hi Kristie, Thank you for sharing your story. Ive had my Flexitouch for almost five months. 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. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /Font << The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) 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.. Thank you for writing. 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.