2 0 obj In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. /Rect [90.257 252.64 421.33 266.44] XJ /Type /Page The woman from Idaho said her arm was softer and found the machine easy to use. 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. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /TT2 51 0 R I did send them an email and asked them to look at your case again. I wanted to talk to some people who had actually used the pump. 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 decrease in quality of life/overall health. /StructParents 2 2016;14(4):198205. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! stream I would be interested to hear how your husbands experience with his new pump. Support Care Cancer (2020). Developing Lymphedema and not being able to get the help that I neededwas awful. The woman from Idaho said her arm was softer and found the machine easy to use. 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. >> Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /W 0 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. My interest in pumps suddenly skyrocketed! Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? /Parent 2 0 R Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. 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. Search. 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. Percentage of each response captured. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. >> Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Do you know of anyone whom would want to buy it? 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. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. 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. /StructParents 0 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). 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /MediaBox [0 0 612 792] Ive had my Flexitouch for almost five months. Thank you for writing. >> /URI (http://www.fda.gov/) 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. 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. /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 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. Pembrolizumab plus cetuximab in patients with recurrent . Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. It delivers a noninvasive therapy that patients can administer themselves at home. << Out of my sleeve, my 3/4 length sleeves arent as tight. /TT1 57 0 R Material and methods Design and participants /BS << /S /URI So for almost every night for the next seven years I sat down and performed MLD on my left arm. /Parent 2 0 R << Adams, KE, Rasmussen JC, Darne C, et al. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /Im0 60 0 R Keep in touch! Deng J, et al. In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with the Flexitouch Plus device. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. 17 0 obj 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. endobj Please write back in a month or so and let us know your progress. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] My best to you. Its amazing how we are communicating so much more through technology because of Covid. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. << 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. 2010; Vol. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. Im a pianist and its become my safe place. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Pain will be assessed using the VAS Pain Scale. /StructParents 6 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. Please remove one or more studies before adding more. Hi Kristie, Thank you for sharing your story. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . I cant explain that but I can visually see a difference. << Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. The Flexitouch system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. Refer to the Legal Notice for express terms of use. /Font << >> )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv /Filter /FlateDecode It has made my life miserable. << For more information, https://tactilemedical.com/about-us/. >> Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 8 0 obj Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) /Resources << 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. /Tabs /S << The whole process, though limiting my ambulation, was comfortable and relaxing. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . To pump or not to pumpthat is a question that I hear in the lymphedema community. He just never could get use to using it and being able to don the garments. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. 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. Actually they dont know much about lymphedema. Lymphat Res Biol, 2016. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. This is a long story but I have managed it as best as I can but when I finally was ready to prove to my insurance that the Flexitouch was needed the insurance denied me coverage. /StructParents 7 /Parent 2 0 R /BS << The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /Contents 53 0 R 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. Oral Oncology. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. 5. stream /StructParents 0 See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 I would suggest you keep contacting Tactile Medical. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. . Minneapolis, MN 55416 USA 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. I know many others can as well. My lymphedema therapist also told me that the pumps werent worth it. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. endstream Numerous garment and program options to meet each patient's unique treatment needs endobj Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Top reviews. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. /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] 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. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. >> /Type /Action endobj I?m 5? It delivers a noninvasive therapy that patients can administer themselves at home. Tactile Systems Technology, Inc. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. >> 2. Reading or watching TV are the activities Im able to do while Im being treated. JAMA Dermatol. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch.
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