In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. stream Thank you for sharing and being an advocate for lymphedema! 7 0 obj I was rather startled at how wrapped up I was. 3701 Wayzata Blvd, Suite 300 Phone: 1.612.355.5100 Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Heart failure (acute pulmonary edema, decompensated acute heart failure) /Font << >> The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. What is encouraging is that you have had success with managing your lymphedema! stream >> Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. stream endstream Its also a relief not to manually MLD my arm every night. Keep in touch! The pump is called the Flexitouch System by Tactile Medical. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Thanks. 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. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Study record managers: refer to the Data Element Definitions if submitting registration or results information. >> Deng J, et al. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. /TT0 49 0 R She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. >> Study record managers: refer to the Data Element Definitions if submitting registration or results information. >> The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. It delivers a noninvasive therapy that patients can administer themselves at home. /Filter /FlateDecode Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /Im0 60 0 R Minneapolis, MN 55416 USA To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Information provided by (Responsible Party): The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. /Rotate 0 /Rect [90.257 252.64 421.33 266.44] Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. /Filter /FlateDecode endobj endobj * American Society of Clinical Oncology 1. 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. 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. /TT0 69 0 R /Subtype /Link >> did you sell it yet? /StructParents 0 For general information, Learn About Clinical Studies. 3. I was told purchased high priced left garments which I dont think I needed. 2. Talk with your doctor and family members or friends about deciding to join a study. 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. /TT3 59 0 R /StructParents 7 I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. 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 . endobj /StructParents 0 /Type /Page A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. 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. NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. Ridner, S.H., Dietrich, M.S., Deng, J. et al. They will reach out to Flexitouch in the process of creating a segment for the news. endobj /MediaBox [0 0 612 792] It has become so bad that I can barely walk. 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. 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. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Learn More Take the steps now to help your head and neck cancer survivors. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. Muluk SC, Hirsch AT, Tafe EC. >> Subject overall health and quality of life in the past week-EORTC C30. /Length 498 O ce they are used the government wont always them to use them on another. {%AIqEWRA>, Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 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. >> 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. Then I got my flexitouch and my life changed. /CropBox [0.0 0.0 612.0 792.0] 1. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /Pages 2 0 R /Length 450 2016;14(4):198205. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Phone: 1.612.355.5100 +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. << Yes, taking care of ones body requires several interventions. /Length 680 I have skipped 1 or 2 days just 3 or 4 times since March. It delivers a noninvasive therapy that patients can administer themselves at home. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. 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. /S /Transparency 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. /MediaBox [0 0 612 792] It takes just 32 minutes per day. /Group << Do you know of anyone whom would want to buy it? /W 0 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. Hopefully it will give me a better quality of life because I dont know what else to do at this point. Listing a study does not mean it has been evaluated by the U.S. Federal Government. phone: +1 (623) 738-9011 (57) Webstore 3. Support Care Cancer (2020). Has anyone else had any experience with this? Muluk SC, Hirsch AT, Tafe EC. 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 have been suffering from lymphedema for the past 2 years. It takes just 32 minutes per day. >> /A << Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. If Im out late, I use it in the morning and then resume again in the evening. >> >> Positive value shows an increase in symptoms/problems. 5. Lymphat Res Biol, 2016. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. They use them in the morning, at nightand feel very lucky.. I need help but theres a no return policy. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Negative value shows a decrease in symptoms/problems. 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. Negative value shows a decrease in Function/Range of Motion. /Type /Page 0 T 14(4): p. 198-205. I did send them an email and asked them to look at your case again. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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. I would contact your local news station that has a consumer investigation/help line. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. /Parent 2 0 R You have reached the maximum number of saved studies (100). ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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.. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. 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. Actually they dont know much about lymphedema. /Count 7 D/N500187-000-00 Rev. /Tabs /S /Length 412 The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. /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] Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). Please remove one or more studies before adding more. You are benefiting the lymphedema community. Support Care Cancer (2020). 2010; Vol. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. >> 2 0 obj 11 0 obj >> They are usually called something like 7 on your side or Channel 3 helps you. /StructParent 1 << It delivers a noninvasive therapy that patients can administer themselves at home. Its amazing to me how little doctors know about lymphedema. /Length 470 Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. /Type /Page They are programed for each individual. 1. /Im0 24 0 R /Font << endobj The pump has helped you achieve significant results. /Rotate 0 Hi Wally, Hope someone is able to meet your request. 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. 1. 7nwJ@6]?t~.} 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. 4? Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. 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. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. I always start with the one hour full arm and core setting. /C2_1 55 0 R Numerous garment and program options to meet each patient's unique treatment needs Thumbs up for Flexi-Touch!! 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. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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.. /Type /Group /Subtype /Link I have it in both of my legs mostly in my thighs. Ridner, S.H., Dietrich, M.S., Deng, J. et al. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! /TT2 58 0 R Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. /XObject << Toll-free: 1.833.3TACTILE (1.833.382.2845) >> Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational /Font << Its been tough . Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? All stars. https://doi.org/10.1007/s00520-020-. /Font << About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . >> Last updated March 2021. Positive value shows an increase in swelling. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. /BS << 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 . What really gripes me is that my nurse practitioner wouldnt even consider ordering one. /CS /DeviceRGB . I have a uniboot compressions on both of my calves. Except for my wrist, all my measurements showed reduction. /F 4 /URI (http://www.fda.gov/) Swelling will be assessed using the ALOHA measurement protocol. /Type /Page /TT1 70 0 R 2. How customer reviews and ratings work See All Buying Options. 46(4): 480487. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). where is the compassion for ill people that NEED certain healthcare to get better? 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. Support Care Cancer (2020). /Group << >> 3 total ratings, 2 with reviews There was a problem filtering reviews right now. Flexitouch Pd32-u Lymphedema Treatment System Pump. Please remove one or more studies before adding more. /Parent 2 0 R >> I had a mastectomy and 9 lymph nodes removed 3 months ago. Filter by. /Resources << Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. 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. /Contents 75 0 R << Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Your email address will not be published. Reading or watching TV are the activities Im able to do while Im being treated. I decided to purchase one without insurance. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. endobj 12 0 obj 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. 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. Since using the Flexitouch for almost a year, she had not experienced cellulitis. I dont know if it will make a difference. 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. 4 0 obj Negative value shows a decrease in pain. 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. 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 An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Ive had my Flexitouch for almost five months. I have been having weekly physical therapy to help with lymphedema and range of motion issues. Buying a reconditioned machine saved me some money. /TT3 74 0 R 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. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. /Type /Page 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. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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 bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. 2008-2023 HMP Global, Inc. All rights reserved. So for almost every night for the next seven years I sat down and performed MLD on my left arm. /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
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