/C2_0 54 0 R Its New, Your email address will not be published. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Negative value shows a increase in quality of life. /Subtype /Link Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time /Type /Group Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. I am looking for a left arm garment for the flexitouch plus. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. My best to you. View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, 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. /TT0 69 0 R Hopefully it will give me a better quality of life because I dont know what else to do at this point. UGH! << I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. Lymphat Res Biol, 2016. In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. /Rotate 0 Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? Yes, taking care of ones body requires several interventions. /XObject << A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Its amazing to me how little doctors know about lymphedema. My interest in pumps suddenly skyrocketed! | Source: Muluk SC, Hirsch AT, Tafe EC. << It takes just 32 minutes per day. It seems a lot of pumps are preprogrammed for the individual. 2016;14(4):198205. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? Pain will be assessed using the VAS Pain Scale. Most significantly was the reduction in my forearm. /S /URI 1. 2 0 obj /Length 680 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. Please remove one or more studies before adding more. /Font << 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. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 4 0 obj Toll-free: 1.833.3TACTILE (1.833.382.2845) << endobj Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs /Pages 2 0 R I was told purchased high priced left garments which I dont think I needed. We rely on the generosity of individuals and sponsors who support our mission and activities. Flexitouch Plus provides flexible program options. 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. >> Top reviews. 10 0 obj Minneapolis, MN 55416 USA Many, many of my patients love their pump. I had a mastectomy and 9 lymph nodes removed 3 months ago. 2015;151(11):11871193. I have a pump system left and right leg also stomach wraps. PW!\v(jfz:yX 8$W"wqHbxQDL I have lymphedema near globally at this point and am trying to obtain coverage via insurance. I used it a few times and Im good now. (Clinical Trial). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. endobj 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. * American Society of Clinical Oncology 1. 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 ] /TT0 69 0 R D/N500187-000-00 Rev. 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. Looking at his ankles there IS no swelling now. Its my new normal and Im thankful!! Developing Lymphedema and not being able to get the help that I neededwas awful. Material and methods Design and participants 1. /A << Two years on pump controller and garments. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. /Rotate 0 /Font << It was a blow to the life I had that I once had. >> 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. >> /CropBox [0.0 0.0 612.0 792.0] So we appealed 3 times. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Its also a relief not to manually MLD my arm every night. /S /URI A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. >> /StructParents 7 /A << I just received it yesterday and Im super hopeful that it will help. /TT2 72 0 R /Resources << (Therapists couldnt afford themselves to take insurance payments because most insurances do not reinburse them enough to make it worthwhile) All in all I finally found the Lymphedema Center (why dont doctors know this) and took some classes and found an amazing therapist who has helped and has been trained in lymphedema and a few massage therapists that know what they are doing and are trained. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. endobj /Group << For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . Chronic Wounds 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. All subjects will receive a single intervention. /StructParents 2 /MediaBox [0.0 0.0 612.0 792.0] 3701 Wayzata Blvd, Suite 300 >> Positive value shows an increase in Function/Range of Motion. Ive had my Flexitouch for almost five months. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /Parent 2 0 R /MediaBox [0.0 0.0 612.0 792.0] /Type /Page Words like new kind of pump, different than the old types, favorable studies, and Dr. 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. 5 0 obj document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. It delivers a noninvasive therapy that patients can administer themselves at home. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 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! HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Dr. Shelia Ridner Dr. Barbara Murphy 2. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. 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/. They use them in the morning, at nightand feel very lucky.. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Surprisingly, my therapists measurements showed minimal difference with previous measurements. 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. Negative value shows a decrease in symptoms/problems. stream << /Annots [10 0 R 11 0 R 12 0 R] 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. /MediaBox [0.0 0.0 612.0 792.0] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) /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 Sort by. 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. 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. 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 Wandalynn . /CropBox [0 0 612 792] Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Refer to the Legal Notice for express terms of use. endstream Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. << Ridner, S.H., Dietrich, M.S., Deng, J. et al. 4. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /Type /Page /Annots [39 0 R] Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. Except for my wrist, all my measurements showed reduction. /CropBox [0.0 0.0 612.0 792.0] My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Please write back in a month or so and let us know your progress. /Font << endobj 2008-2023 HMP Global, Inc. All rights reserved. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. 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. The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. I am delighted to say that hubbys minor leg swelling, from his diabetes and hefty build, are significantly less after Flexi-Touch was added to his health regime by the Diabetes Clinic at the VA Hospital. /StructParents 0 /TT0 49 0 R 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. /Type /Page endobj The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Swelling will be assessed using the ALOHA measurement protocol. I just finished 6 weeks of radiation. It delivers a noninvasive therapy that patients can administer themselves at home. 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. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 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. Numerous garment and program options to meet each patient's unique treatment needs I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. Subject Quality of Life will be assessed using EORTC C30 questionnaire. Buying a reconditioned machine saved me some money. 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.