flexitouch plus head and neck flexitouch plus head and neck

I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. >> /Resources << >> >> 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. H]O0+=) ES My therapist said they cannot be reused by another. Talk with your doctor and family members or friends about deciding to join a study. She explained that compression pumps force air into sleeves with multiple chambers. Just wondering if you have any ideas of whom to contact on such a thing. 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. Support Care Cancer (2020). /Tabs /S . Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Muluk SC, Hirsch AT, Tafe EC. /Filter /FlateDecode /CropBox [0 0 612 792] The leg garments that I received are for a much taller person. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use >> How customer reviews and ratings work See All Buying Options. /Filter /FlateDecode I know many others can as well. /Rotate 0 /StructParents 0 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. 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. /MediaBox [0.0 0.0 612.0 792.0] 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. 6 0 obj 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. >> Deng J, et al. endstream /Type /Page I was told purchased high priced left garments which I dont think I needed. Its New, Your email address will not be published. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /Filter /FlateDecode /TT0 69 0 R And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. 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. I use it everyday for an hour. % Words like new kind of pump, different than the old types, favorable studies, and Dr. >> endobj document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Last updated March 2021. 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. 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. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. I dont know if it will make a difference. D/N500187-000-00 Rev. The whole process, though limiting my ambulation, was comfortable and relaxing. For more information, https://tactilemedical.com/about-us/. where is the compassion for ill people that NEED certain healthcare to get better? 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Please remove one or more studies before adding more. I really need this system and had such desperate hope. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 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. I didnt need a lymphedema physical therapist but too much to explain here. My lymphedema therapist also told me that the pumps werent worth it. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Ideas? 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 When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. They are usually called something like 7 on your side or Channel 3 helps you. /Type /Catalog 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 Rockson floated to my ears. >> /Type /Group >> stream Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! 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. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs /TT1 70 0 R Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment /CropBox [0 0 612 792] /StructParents 8 Positive value shows an increase in symptoms/problems. I wonder if pumps can be reprogrammed. /Filter /FlateDecode My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /Im0 60 0 R /Annots [10 0 R 11 0 R 12 0 R] endstream 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. 1. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. 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. Then I got my flexitouch and my life changed. >> When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. 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. >> It delivers a noninvasive therapy that patients can administer themselves at home. Refer to the Legal Notice for express terms of use. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. Its my new normal and Im thankful!! Faced with negative publicity, they often end up making things right. >> https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. The lymphedema seen in patients treated for head . Michelin Man came to mind as I stretched out on the couch. EJVES. /Type /Group I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /Parent 2 0 R 9 0 obj Try contacting different people. 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. 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. Has anyone else had any experience with this? /Type /Action I wanted to talk to some people who had actually used the pump. 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. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. /CropBox [0 0 612 792] 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. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. This is not anadvertisement for Flexitouch.). 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. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. between head and neck cancer and lymphedema. Heart failure (acute pulmonary edema, decompensated acute heart failure) >> /CS /DeviceRGB /TT0 23 0 R 2013; Vol. /TT2 58 0 R 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. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . Your email address will not be published. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. September 30, 2021 09:03 ET /Filter /FlateDecode Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. << 3 0 obj The warranty was the same as a new machine. /A << They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. /Type /Page While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. >> /Type /Pages It delivers a noninvasive therapy that patients can administer themselves at home. It seems a lot of pumps are preprogrammed for the individual. 1 0 obj 2. 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. /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 When she said piano I froze. To pump or not to pumpthat is a question that I hear in the lymphedema community. /URI (http://www.fda.gov/) /Contents 53 0 R Free shipping for many products! /CropBox [0.0 0.0 612.0 792.0] Upper set (head and neck). I have skipped 1 or 2 days just 3 or 4 times since March. 2 0 obj https://doi.org/10.1007/s00520-020-05540-8, 3. 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. /TT3 72 0 R document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. The Flexitouch System is not used for nor intended for use to treat cellulitis. 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. * American Society of Clinical Oncology 1. /Count 7 Its brand new, used 1 time. 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 ] The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. >> 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. Top reviews. /S /Transparency endstream Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. >> endobj Lymphedema /Rotate 0 Swelling will be assessed using the ALOHA measurement protocol. << 1. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). /W 0 Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. My husband?s pump system arrived yesterday. 3701 Wayzata Blvd, Suite 300 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. It takes just 32 minutes per day. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. (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. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) They are in contact with patients who could benefit from a pneumatic pump. I just received the flexitouch plus, but I think the leg garments are too big. 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. 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.