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Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. >> 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. 2016;14(4):198205. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Numerous garment and program options to meet each patient's unique treatment needs 7nwJ@6]?t~.} Toll-free: 1.833.3TACTILE (1.833.382.2845) << /Type /Action 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. /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] 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. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. 1. << 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. My interest in pumps suddenly skyrocketed! Its my new normal and Im thankful!! /CropBox [0.0 0.0 612.0 792.0] A healthy lymphatic system moves lymph fluid throughout the body. /StructParents 7 I cant explain that but I can visually see a difference. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. >> Actually they dont know much about lymphedema. Ml6(|a\!A.;Q#[. /Contents 73 0 R 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 Both Ease of Use/Satisfaction will be assessed by survey. /S /URI 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. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Managing my lymphedema requires attention and an assortment of tools. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Flexitouch Pd32-u Lymphedema Treatment System Pump. /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] News Release Details - Tactile Systems Technology, Inc. /ProcSet [/PDF /Text /ImageC] I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. (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. 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. /Font << 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 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 go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. Negative value shows a decrease in swelling. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. /Contents 53 0 R /MediaBox [0 0 612 792] /Length 412 Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Venous Ulcers. Talk with your doctor and family members or friends about deciding to join a study. Support Care Cancer (2020). Adams, KE, Rasmussen JC, Darne C, et al. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. We were asked to improve the ease of donning . H]O0+=) ES 3. 2 0 obj I know many others can as well. Just wondering if you have any ideas of whom to contact on such a thing. /GS0 37 0 R /S /Transparency Your email address will not be published. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional /Filter /FlateDecode 2016;14(4):198205. (Note: There are other well regarded pumps on the market. /A << Has anyone else had any experience with this? endobj ? Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts /Length 585 Breast cancer and treatment in itself was an awful journey. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). 14(4): p. 198-205. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. 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. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Phone: 1.612.355.5100 NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Flexitouch Plus - Tactile Medical /MediaBox [0.0 0.0 612.0 792.0] /TT3 72 0 R Last updated March 2021. 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. Text, image, video. /StructParents 8 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/. Last updated March 2021. /CS /DeviceRGB I just received it yesterday and Im super hopeful that it will help. << HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ /C2_1 55 0 R /Tabs /S 3 0 obj UGH! 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch /Resources << 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 is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. 17 0 obj 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. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Deng J, et al. /TT1 50 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. Filter by. /Rotate 0 K-ZB: I have been suffering from lymphedema for the past 2 years. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. Positive value shows an increase in Function/Range of Motion. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? 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. 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. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Hi Jaime, Im hopeful that your new pump will provide relief. >> /TT0 22 0 R The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. The content is not intended to substitute manufacturer instructions. /Pages 2 0 R /ProcSet [/PDF /Text] Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Any circumstance where increased lymphatic or venous return is undesirable /URI (http://www.fda.gov/) Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. [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. Negative value shows a increase in quality of life. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. stream /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 I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. << /Type /Page Material and methods Design and participants Lymphat Res Biol. For general information, Learn About Clinical Studies. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /TT1 70 0 R Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. /TT2 58 0 R /Rotate 0 I would suggest you keep contacting Tactile Medical. >> Positive value shows an increase in symptoms/problems. /Filter /FlateDecode 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. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Toll-free: 1.833.3TACTILE (1.833.382.2845) /MediaBox [0.0 0.0 612.0 792.0] My skin appears more like the skin on my right arm. The warranty was the same as a new machine. 4? Tens of thousands of. >> They use them in the morning, at nightand feel very lucky.. >> /F 4 I just received the flexitouch plus, but I think the leg garments are too big. I?m 5? In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. /Type /Action >> I had a mastectomy and 9 lymph nodes removed 3 months ago. >> Tens of thousands of. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /Subtype /Link 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. It delivers a noninvasive therapy that patients can administer themselves at home. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I have been having weekly physical therapy to help with lymphedema and range of motion issues. Hi Kristie, Thank you for sharing your story. Please remove one or more studies before adding more. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. (6Kjw_XGz'g &p document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. 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. endobj 35 0 R] 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. I chatted with a woman from Tacoma and another from Idaho. 2015;151(11):11871193. O ce they are used the government wont always them to use them on another. endobj G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp 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! HTo0~G6)BjH7u /Annots [39 0 R] Please remove one or more studies before adding more. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Phone: 1.612.355.5100 /F 4 Tactile Medical Announces Enrollment of First Patient in /Type /Group stream /C2_0 54 0 R /MediaBox [0 0 612 792] 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. 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. >> Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. /StructParents 0 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.. /Resources << 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. k Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. << Top reviews. did you sell it yet? eIb? 0 T The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections.