& weigh 126 lbs. /StructParents 0 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. endobj /Group << Negative value shows a decrease in pain. Most significantly was the reduction in my forearm. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. /MediaBox [0 0 612 792] >> /TT2 51 0 R Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 2008-2023 HMP Global, Inc. All rights reserved. >> Thank you for sharing and being an advocate for lymphedema! >> Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. /Length 585 /StructParents 6 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. Last updated March 2021. /Rotate 0 I wish you success! . /TT3 72 0 R /MediaBox [0.0 0.0 612.0 792.0] endobj Its something Im passionate about. endstream 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. >> Its amazing how we are communicating so much more through technology because of Covid. << Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 5. /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] /TT3 52 0 R where is the compassion for ill people that NEED certain healthcare to get better? Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /Rotate 0 /Resources << Any circumstance where increased lymphatic or venous return is undesirable So we appealed 3 times. Thanks. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Except for my wrist, all my measurements showed reduction. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) 17 0 obj Thank you for writing. I have skipped 1 or 2 days just 3 or 4 times since March. stream Support Care Cancer (2020). 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.. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I use it everyday for an hour. /Rotate 0 This is not anadvertisement for Flexitouch.). >> 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. /TT0 69 0 R /MediaBox [0 0 612 792] Numerous garment and program options to meet each patient's unique treatment needs endobj << /Rotate 0 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. stream Toll-free: 1.833.3TACTILE (1.833.382.2845) | Source: HTo0~G6)BjH7u >> Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. 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. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /Rect [40.95 36 85.101 45.216] 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.. My interest in pumps suddenly skyrocketed! /StructParent 1 I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. 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. All subjects will receive a single intervention. /C2_0 48 0 R 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. endobj >> HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). The pump is called the Flexitouch System by Tactile Medical. 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. Support Care Cancer (, 2020). /ProcSet [/PDF /Text] Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /Type /Pages The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. (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. Upper set (head and neck). Hi Kristie, Thank you for sharing your story. /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] )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 I have little confidence that the FaceTime call offered will be of much use. >> I just received the flexitouch plus, but I think the leg garments are too big. /MediaBox [0.0 0.0 612.0 792.0] Why Should I Register and Submit Results? Reading or watching TV are the activities Im able to do while Im being treated. 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. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. Im only 44 years old , and I have kids that need mom back. 1. 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. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. << The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Deng J, et al. /TT1 70 0 R 35 0 R] /S /Transparency 2015;151(11):11871193. /S /URI My husband has a brand new system that Im trying to sell. 2. endobj Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. I have a pump system left and right leg also stomach wraps. Negative value shows a decrease in symptoms/problems. /TT1 70 0 R I did a baseline measurement of my left arm before treatment and three weeks after using the pump. They are in contact with patients who could benefit from a pneumatic pump. Two years on pump controller and garments. /A << !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N I did send them an email and asked them to look at your case again. /Resources << It delivers a noninvasive therapy that patients can administer themselves at home. Talk with your doctor and family members or friends about deciding to join a study. I dont know if it will make a difference. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. (Clinical Trial). endobj Negative value shows a decrease in swelling. Try contacting different people. 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. Im a pianist and its become my safe place. >> 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. /Type /Page September 30, 2021 09:03 ET Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Text, image, video. /Contents 75 0 R Negative value shows a decrease in quality of life/overall health. I have lymphedema in my right arm, breast and axilla. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> Choosing to participate in a study is an important personal decision. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. Overview Product Features Details Benefits 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. /CropBox [0.0 0.0 612.0 792.0] /S /URI /CS /DeviceRGB endstream I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /Annots [10 0 R 11 0 R 12 0 R] k Please remove one or more studies before adding more. /Rect [40.95 36 85.101 45.216] 7nwJ@6]?t~.} /StructParents 8 My lymphedema therapist also told me that the pumps werent worth it. Filter by. 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. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. 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. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time It seems a lot of pumps are preprogrammed for the individual. /Subtype /Link /Rotate 0 The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. 6 0 obj /Parent 2 0 R The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Managing my lymphedema requires attention and an assortment of tools. endobj endobj XJ 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. /ExtGState << >> 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. >> ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN Hi Jaime, Im hopeful that your new pump will provide relief. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. 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/. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. Free shipping for many products! (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. Its also a relief not to manually MLD my arm every night.
flexitouch plus head and neck
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flexitouch plus head and neck
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