Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. 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. 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. /Rotate 0 endobj Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. 4. /Length 412 phone: +1 (623) 738-9011 (57) Webstore 3. /Font << For more information, https://tactilemedical.com/about-us/. I have skipped 1 or 2 days just 3 or 4 times since March. /MediaBox [0 0 612 792] /Count 7 /Rotate 0 HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 2 0 obj 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. Rockson floated to my ears. /Contents 75 0 R /Type /Page 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. /MediaBox [0.0 0.0 612.0 792.0] Advanced Techniques in Canine and Feline Neurosurgery The Flexitouch Plus system should not be used on patients with one or more of the following conditions: /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /Resources << The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. content.edgar-online.com About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . x endobj 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. Tactile Medical Announces Enrollment of First Patient in - Yahoo! Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. We were asked to improve the ease of donning . Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. https://doi.org/10.1007/s00520-020-05540-8, 3. Do you know of anyone whom would want to buy it? Muluk SC, Hirsch AT, Tafe EC. 5 0 obj I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. My husband has a brand new system that Im trying to sell. /TT1 57 0 R Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP PW!\v(jfz:yX 8$W"wqHbxQDL >> /F 4 Pain will be assessed using the VAS Pain Scale. My insurance company required me to use a different brand of compression pump and experience failure before they would consider covering the cost of a Flexitouch. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. 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. 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. Tactile Medical Announces Enrollment of First Patient in << 3701 Wayzata Blvd, Suite 300 My interest in pumps suddenly skyrocketed! >> 2. Explain the situation to them. September 30, 2021 09:03 ET 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. << /S /URI Tactile Systems debuts Flexitouch head and neck lymphedema treatment >> Choosing to participate in a study is an important personal decision. 14(4): p. 198-205, 2. Lymphedema Treatment in Head and Neck Cancer Patients >> For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. /CropBox [0 0 612 792] >> >> It has made my life miserable. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). How customer reviews and ratings work See All Buying Options. Hi Wandalynn . Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. >> 7 0 obj Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. >> Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. endobj /Tabs /S https://doi.org/10.1007/s00520-020-. 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. Flexitouch Pd32-u Lymphedema Treatment System Pump. I have been having weekly physical therapy to help with lymphedema and range of motion issues. /Parent 2 0 R I am looking for a left arm garment for the flexitouch plus. /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] NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( /TT2 71 0 R Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Im0 60 0 R Since using the Flexitouch for almost a year, she had not experienced cellulitis. I greatly encourage others to try to obtain one if they are able and if it is a good option for them. 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^ stream /TT0 22 0 R Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. 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.. They are programed for each individual. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Text, image, video. /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 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. 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. I had a mastectomy and 9 lymph nodes removed 3 months ago. /TT1 70 0 R 1. Breast cancer and treatment in itself was an awful journey. 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/. Hi Kathi, The FaceTime call might work! A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. When I first went to physical therapy, she was running through some more common contibuters to swelling. Upper set (head and neck). >> But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. Actually they dont know much about lymphedema. 4? >> XJ Everything in my life that I do and love and I am passionate about invloves using my hands and arms. My go to place when I need calming. Negative value shows a increase in quality of life. Oral Oncology. /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 last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. Reading or watching TV are the activities Im able to do while Im being treated. /BS << /StructParents 7 Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. 1(1): 114125. The woman from Idaho said her arm was softer and found the machine easy to use. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Tens of thousands of. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. 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. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. I did send them an email and asked them to look at your case again. 18 0 obj (6Kjw_XGz'g &p /Font << 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) . document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /C2_0 38 0 R I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. History of the Northwest Lymphedema Center. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp /Contents 73 0 R /Filter /FlateDecode /Tabs /S stream A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. For general information, Learn About Clinical Studies. >> Its also a relief not to manually MLD my arm every night. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 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. 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch 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. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. Hi Karyn, I will post your comment and see if Sarah still has the pump available. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use It was up to me to piece it together. Choosing to participate in a study is an important personal decision. << Phone: 1.612.355.5100 I have been suffering from lymphedema for the past 2 years. Keep sharing your story. Subject Quality of Life will be assessed using EORTC C30 questionnaire. Support Care Cancer (2020). Its amazing how we are communicating so much more through technology because of Covid. Deng J, et al. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. << Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /BS << /W 0 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. I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. /Type /Group They are in contact with patients who could benefit from a pneumatic pump. Hi Kristie, Thank you for sharing your story. 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. endobj This is not anadvertisement for Flexitouch.). The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /Type /Action Then I got my flexitouch and my life changed. Tactile Medical braces for new Medicare rules that will tighten access /TT2 51 0 R The Flexitouch Plus 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. They are usually called something like 7 on your side or Channel 3 helps you. /CS /DeviceRGB My insurance paid for all of it and the Tactile rep will help you get that. So for almost every night for the next seven years I sat down and performed MLD on my left arm. /TT0 56 0 R The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /TT0 69 0 R /CropBox [0.0 0.0 612.0 792.0] YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! 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. endstream /Annots [10 0 R 11 0 R 12 0 R] Lymphedema - Head and Neck Cancer Alliance 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. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. I have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. Chronic Wounds Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N They only measured the circumference of my thighs and calfskin, not the length, so now I am STUCK with a non-refundable almost 9K system that is too long for me. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. >> Numerous garment and program options to meet each patient's unique treatment needs /Type /Group endobj Clinical Trial on Head and Neck Cancer: Flexitouch Plus system Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) /Length 585 >> 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. Lymphat Res Biol. /C2_0 48 0 R Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 2010; Vol. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Rz:MzI6 eIb? /StructParent 1 /Pages 2 0 R S * American Society of Clinical Oncology 1. H]O0+=) ES /CropBox [0.0 0.0 612.0 792.0] I only make 12k per year so its not like I can afford anything. /Filter /FlateDecode endobj endobj 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. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. /TT0 69 0 R /Subtype /Link Negative value shows a decrease in quality of life/overall health. 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 Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /ProcSet [/PDF /Text /ImageC] Positive value shows an increase in quality of life/overall health. 13 0 obj 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. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Its my new normal and Im thankful!! Your email address will not be published. Minneapolis, MN 55416 USA Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454.
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