flexitouch plus head and neckupenn fall 2022 courses

/S /URI >> Managing my lymphedema requires attention and an assortment of tools. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. /Type /Group /C2_0 38 0 R Actually they dont know much about lymphedema. Phone: 1.612.355.5100 The content is not intended to substitute manufacturer instructions. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Negative value shows a decrease in Function/Range of Motion. /TT0 23 0 R Numerous clinical studies show achievement of major clinical benefits and cost savings Lymphat Res Biol. 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 /W 0 My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /Font << Ive had my Flexitouch for almost five months. endobj I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. I just finished 6 weeks of radiation. >> Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? /TT1 70 0 R %PDF-1.4 !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ 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. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. If anyone has one, or knows of one, please contact me. I would contact your local news station that has a consumer investigation/help line. 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. /ProcSet [/PDF /Text] YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! /Contents 73 0 R The warranty was the same as a new machine. 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. 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. 0 T Support Care Cancer (2020). stream XJ We were asked to improve the ease of donning . What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /ProcSet [/PDF /Text /ImageC] Support Care Cancer (2020). document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. I always start with the one hour full arm and core setting. Deng J, et al. /TT0 69 0 R 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 << /Contents 75 0 R << +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP 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 . >> /Rect [90.257 252.64 421.33 266.44] 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. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ >> They will reach out to Flexitouch in the process of creating a segment for the news. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Pain will be assessed using the VAS Pain Scale. Write a review. EJVES. >> endstream Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. endobj | Source: The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Required fields are marked *. /TT2 71 0 R << 1(1): 114125. /TT3 52 0 R Positive value shows an increase in quality of life/overall health. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. HTo0~G6)BjH7u /Parent 2 0 R Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? Filter by. During pregnancy (applies only to the Flexitouch Plus trunk accessory). What really gripes me is that my nurse practitioner wouldnt even consider ordering one. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. /Length 498 Ridner, S.H., Dietrich, M.S., Deng, J. et al. /ProcSet [/PDF /Text /ImageC] 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. /MediaBox [0 0 612 792] /TT2 72 0 R 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/. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. 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. Keep in touch! 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. I have been having weekly physical therapy to help with lymphedema and range of motion issues. >> }3eIH]^p~>_ y#h`*#OPQB_lVI"p! 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 ] Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /C2_0 54 0 R A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. 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. Any circumstance where increased lymphatic or venous return is undesirable Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. between head and neck cancer and lymphedema. endstream >> /Type /Page Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? Your email address will not be published. /XObject << 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. 2 0 obj /CropBox [0 0 612 792] 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.. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Talk with your doctor and family members or friends about deciding to join a study. I am looking for the leg and trunk model is that what you have? /Group << 18 0 obj /Version /1.4 Percent change is calculated by the difference between scores averaged at 6 months versus baseline. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN You have reached the maximum number of saved studies (100). endobj The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. I just received it yesterday and Im super hopeful that it will help. All stars. /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] In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. /Tabs /S (Clinical Trial). does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? /Font << >> I like to joke, Honey, time for me to put the squeeze on you It delivers a noninvasive therapy that patients can administer themselves at home. It has become so bad that I can barely walk. Thank you for sharing and being an advocate for lymphedema! 2. * American Society of Clinical Oncology 1. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). 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. /F 4 Except for my wrist, all my measurements showed reduction. << And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. x It was up to me to piece it together. Hi Deborah, How wonderful you have had such positive success with your pump. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. 2008-2023 HMP Global, Inc. All rights reserved. My thighs are so big that I can no longer Drive. /CropBox [0.0 0.0 612.0 792.0] Words like new kind of pump, different than the old types, favorable studies, and Dr. The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). I didnt make a decision to purchase a pump that day. ? /C2_0 48 0 R 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. The woman from Idaho said her arm was softer and found the machine easy to use. Out of my sleeve, my 3/4 length sleeves arent as tight. Explain the situation to them. /BS << Refer to the Legal Notice for express terms of use. Surprisingly, my therapists measurements showed minimal difference with previous measurements. /Font << Learn how your comment data is processed. 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.. 8 0 obj Ideas? The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /Rotate 0 /W 0 I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 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. /StructParents 7 Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I have skipped 1 or 2 days just 3 or 4 times since March. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. /MediaBox [0 0 612 792] The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. I cant explain that but I can visually see a difference. /URI (http://www.fda.gov/) The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /MediaBox [0.0 0.0 612.0 792.0] << First of all I cant drive, and second I have to pay a $60 copay every time I go. Its been tough . While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Minneapolis, MN 55416 USA Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. 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. September 30, 2021 09:03 ET A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 3701 Wayzata Blvd, Suite 300 /A << Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! Study record managers: refer to the Data Element Definitions if submitting registration or results information. My best to you. My lymphedema therapist also told me that the pumps werent worth it. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /A << /Resources << We rely on the generosity of individuals and sponsors who support our mission and activities. >> /Font << Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. (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. Im sorry for the experience you had with Tactile Medical. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. /Filter /FlateDecode Negative value shows a decrease in symptoms/problems. /StructParents 6 Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) I have one new for sale. Negative value shows a decrease in quality of life/overall health. 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. 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. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /Parent 2 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. 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. 2015 51 (431-437), 1. https://doi.org/10.1007/s00520-020-05540-8, 3. /TT1 50 0 R endobj Rockson floated to my ears. 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. My go to place when I need calming. /Rotate 0 /Type /Page If Im out late, I use it in the morning and then resume again in the evening. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. 10 0 obj Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /TT2 58 0 R 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. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. Hi Kristie, Thank you for sharing your story. >> /Subtype /Link /Type /Pages Reading or watching TV are the activities Im able to do while Im being treated. 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. 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 have a uniboot compressions on both of my calves. 5. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). 12 0 obj Positive value shows an decrease in quality of life. The pump has helped you achieve significant results. My husband?s pump system arrived yesterday. /Rotate 0 To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /ExtGState << Lymphedema /ProcSet [/PDF /Text] /Tabs /S /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 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. 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! I can no longer Drive, go to the grocery store, take my kids for a walk or go to the park or anywhere for that matter. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. The Head & Neck Program is just 32 minutes long. When she said piano I froze. 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. >> Flexitouch Pd32-u Lymphedema Treatment System Pump. /CropBox [0 0 612 792] /Resources << https://doi.org/10.1007/s00520-020-. Then I got my flexitouch and my life changed. I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Its New, Your email address will not be published. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. Its brand new, used 1 time. 3. 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 /Action I am looking for a left arm garment for the flexitouch plus. /Font << Please write back in a month or so and let us know your progress. Sort by. 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. stream It takes just 32 minutes per day. I know many others can as well. eIb? Buying a reconditioned machine saved me some money. Can I use the machine on lower limbs with compression garments above? 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 $87.98 Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. He just never could get use to using it and being able to don the garments. Has anyone else had any experience with this? G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp 3701 Wayzata Blvd, Suite 300 /Length 450 46(4): 480487. /Annots [39 0 R] >> Positive value shows an increase in swelling. >> /Rotate 0 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. Please cross your fingers for me that this works. 14(4): p. 198-205, 2. 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. >> 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Im only 44 years old , and I have kids that need mom back. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. 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. /W 0 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. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Type /Page 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. /C2_0 21 0 R Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /Length 470 Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. They are programed for each individual. /S /Transparency Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. Tens of thousands of. k 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. 9 0 obj 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. Flexitouch Plus provides flexible program options. Its my new normal and Im thankful!! The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. 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/. 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.

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