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. 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. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. I have little confidence that the FaceTime call offered will be of much use. Another set of pads enveloped my left thigh and trunk. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Breast cancer and treatment in itself was an awful journey. /C2_0 54 0 R The lymphedema seen in patients treated for head . 13 0 obj Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Phone: 1.612.355.5100 Support Care Cancer (2020). A healthy lymphatic system moves lymph fluid throughout the body. I decided to purchase one without insurance. Hopefully it will give me a better quality of life because I dont know what else to do at this point. /S /URI Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. 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. endstream I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. Free shipping for many products! >> The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I would suggest you keep contacting Tactile Medical. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Yes, taking care of ones body requires several interventions. << 2016;14(4):198205. Do you know of anyone whom would want to buy it? >> So we appealed 3 times. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. I was rather startled at how wrapped up I was. /Parent 2 0 R Im sorry for the experience you had with Tactile Medical. >> /Type /Group Flexitouch . endobj 5 0 obj >> >> /Length 412 Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] I need help but theres a no return policy. 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. /Parent 2 0 R Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. /TT1 57 0 R /Type /Page Positive value shows an increase in symptoms/problems. 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. Toll-free: 1.833.3TACTILE (1.833.382.2845) /Rect [90.257 252.64 421.33 266.44] >> While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Positive value shows an increase in quality of life/overall health. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 4. /Filter /FlateDecode 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^ Hi Karyn, I will post your comment and see if Sarah still has the pump available. /Type /Page endobj Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. The Flexitouch System is not used for nor intended for use to treat cellulitis. I wonder if pumps can be reprogrammed. /Contents 36 0 R Write a review. /Rotate 0 It has made my life miserable. 1. 0 T Numerous clinical studies show achievement of major clinical benefits and cost savings I use it every evening. stream /Annots [10 0 R 11 0 R 12 0 R] >> /TT1 23 0 R stream In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The pump is called the Flexitouch System by Tactile Medical. 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. Lymphedema Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. /TT0 23 0 R % Lymphat Res Biol, 2016. They will reach out to Flexitouch in the process of creating a segment for the news. I really need this system and had such desperate hope. 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. (Note: There are other well regarded pumps on the market. /StructParents 0 * American Society of Clinical Oncology 1. 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. stream I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . Negative value shows a increase in quality of life. 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /Type /Page 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. /CropBox [0 0 612 792] The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. I chatted with a woman from Tacoma and another from Idaho. 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 /Tabs /S /TT0 56 0 R A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Heart failure (acute pulmonary edema, decompensated acute heart failure) Thank you for sharing and being an advocate for lymphedema! Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. [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. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. /Length 470 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. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. I dont like that I have to do it but it has changed my legs back to normal. (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. Try contacting different people. If anyone has one, or knows of one, please contact me. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. When I first went to physical therapy, she was running through some more common contibuters to swelling. Tactile Systems Technology, Inc. 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. x 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. 14(4): p. 198-205, 2. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. /TT0 49 0 R /Subtype /Link /Type /Pages The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. The content is not intended to substitute manufacturer instructions. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp /XObject << Its brand new, used 1 time. 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. Chronic Wounds did you sell it yet? >> Thank you for sharing your husbands success with a pump. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Lymphat Res Biol. /Im0 60 0 R Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. stream /TT0 69 0 R /Tabs /S 46(4): 480487. 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. /ProcSet [/PDF /Text /ImageC] Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. I cannot find any shoes that fit my feet or any pants that fit comfortably . Negative value shows a decrease in quality of life/overall health. Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /CS /DeviceRGB endobj Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. 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. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. /Contents 73 0 R 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. Thumbs up for Flexi-Touch!! This is not anadvertisement for Flexitouch.). When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. My insurance paid for all of it and the Tactile rep will help you get that. /C2_0 48 0 R 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. Then I got my flexitouch and my life changed. /Tabs /S Faced with negative publicity, they often end up making things right. Ridner, S.H., Dietrich, M.S., Deng, J. et al. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /Resources << I greatly encourage others to try to obtain one if they are able and if it is a good option for them. My lymphedema therapist also told me that the pumps werent worth it. /Length 498 2016;14(4):198205. endobj Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? All reviewers. /CropBox [0.0 0.0 612.0 792.0] I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. /Parent 2 0 R >> Type of Use (Select one or both, as applicable) lXI . 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. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 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. 2 0 obj Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. << Positive value shows an increase in Function/Range of Motion. /Type /Action Biomedical Optics Express. endobj 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. My thighs are so big that I can no longer Drive. 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. /BS << Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? It has become so bad that I can barely walk. 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. Negative value shows a decrease in pain. 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. What is encouraging is that you have had success with managing your lymphedema! While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. 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.. Has anyone else had any experience with this? Please remove one or more studies before adding more. /Im0 24 0 R HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. /Subtype /Link | Source: /Pages 2 0 R I didnt need a lymphedema physical therapist but too much to explain here. /W 0 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/. /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] /Resources << Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. Ridner, S.H., Dietrich, M.S., Deng, J. et al. I am looking for a left arm garment for the flexitouch plus. 2015 51 (431-437), 1. 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. Just wondering if you have any ideas of whom to contact on such a thing. 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. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /Font << Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Lymphat Res Biol, 2016. In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. >> Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Actually they dont know much about lymphedema. /CropBox [0.0 0.0 612.0 792.0] Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. /BS << 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 did send them an email and asked them to look at your case again. 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. 2. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Oral Oncology. 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday, 3701 Wayzata Blvd, Suite 300 /Filter /FlateDecode >> The Head & Neck Program is just 32 minutes long. << /C2_1 55 0 R Please cross your fingers for me that this works. September 30, 2021 09:03 ET endobj The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /Resources << Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Hi Wandalynn . Sort by. For more information, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! >> !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N 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. Thanks. Ideas? 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.