I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. Yay! Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. 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. 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. Heart failure (acute pulmonary edema, decompensated acute heart failure) Keep sharing your story. I would suggest you keep contacting Tactile Medical. /TT1 57 0 R Filter by. | Source: 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. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. . Thanks. I was told purchased high priced left garments which I dont think I needed. /URI (http://www.fda.gov/) I use it every evening. endstream 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. For more information, https://tactilemedical.com/about-us/. 7nwJ@6]?t~.} XJ Toll-free: 1.833.3TACTILE (1.833.382.2845) /Subtype /Link Hi Wally, Hope someone is able to meet your request. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. It was a blow to the life I had that I once had. /Rotate 0 /CropBox [0.0 0.0 612.0 792.0] They are programed for each individual. 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. /Font << endobj /Rect [90.257 252.64 421.33 266.44] Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I?m 5? Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com Positive value shows an increase in pain. My thighs are so big that I can no longer Drive. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 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. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional The warranty was the same as a new machine. Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /TT0 49 0 R I wanted to talk to some people who had actually used the pump. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic 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 . 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. 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. << HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ /Group << Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? The woman from Idaho said her arm was softer and found the machine easy to use. >> ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. It has become so bad that I can barely walk. /Im0 24 0 R Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /S /Transparency between head and neck cancer and lymphedema. Flexitouch Plus provides flexible program options. /A << In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. /ExtGState << You are benefiting the lymphedema community. 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. 3701 Wayzata Blvd, Suite 300 In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. /Type /Action /TT1 23 0 R Has anyone else had any experience with this? She explained that compression pumps force air into sleeves with multiple chambers. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. UGH! I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. 4? 2016;14(4):198205. Phone: 1.612.355.5100 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. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Study record managers: refer to the Data Element Definitions if submitting registration or results information. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. /CS /DeviceRGB It delivers a noninvasive therapy that patients can administer themselves at home. Positive value shows an increase in quality of life/overall health. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. /Rotate 0 Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. 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. Since using the Flexitouch for almost a year, she had not experienced cellulitis. /Resources << did you sell it yet? 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. Learn More Take the steps now to help your head and neck cancer survivors. Ml6(|a\!A.;Q#[. Subject overall health and quality of life in the past week-EORTC C30. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. /Resources << I dont know if it will make a difference. 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/. 3701 Wayzata Blvd, Suite 300 Pain will be assessed using the VAS Pain Scale. 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. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Talk with your doctor and family members or friends about deciding to join a study. H]O0+=) ES The woman from Idaho said her arm was softer and found the machine easy to use. 6 0 obj Lymphat Res Biol, 2016. 1. Negative value shows a decrease in quality of life/overall health. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. The leg garments that I received are for a much taller person. >> /S /URI /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) ? Your email address will not be published. It seems a lot of pumps are preprogrammed for the individual. I dont like that I have to do it but it has changed my legs back to normal. Tens of thousands of. /TT1 70 0 R I would contact your local news station that has a consumer investigation/help line. I just finished 6 weeks of radiation. Minneapolis, MN 55416 USA The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Search. Minneapolis, MN 55416 USA 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. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN I used it a few times and Im good now. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Its been tough . Positive value shows an increase in swelling. https://doi.org/10.1007/s00520-020-. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. All stars. where is the compassion for ill people that NEED certain healthcare to get better? 2015;151(11):11871193. /C2_1 55 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. 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. Support Care Cancer (2020). The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema /MediaBox [0 0 612 792] Flexitouch Plus - Tactile Medical I like to joke, Honey, time for me to put the squeeze on you /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] Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. >> /Length 450 endstream I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. /Rotate 0 When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. I didnt make a decision to purchase a pump that day. /Resources << 14 0 obj Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /StructParents 6 Its my new normal and Im thankful!! Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 2010; Vol. 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. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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. Learn how your comment data is processed. endstream Swelling will be assessed using the ALOHA measurement protocol. I cannot find any shoes that fit my feet or any pants that fit comfortably . He just never could get use to using it and being able to don the garments. /Rotate 0 >> What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /TT3 74 0 R >> 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. 1(1): 114125. 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 /TT2 71 0 R /Type /Group The head & neck of non-human animals - << The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. /Type /Page Sort by. 5 0 obj The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! O ce they are used the government wont always them to use them on another. Developing Lymphedema and not being able to get the help that I neededwas awful. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. So we appealed 3 times. /StructParents 0 Both Ease of Use/Satisfaction will be assessed by survey. /Resources << /Type /Pages Hi Wandalynn . I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Why Should I Register and Submit Results? They use them in the morning, at nightand feel very lucky.. /CropBox [0.0 0.0 612.0 792.0] Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. /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 >> During pregnancy (applies only to the Flexitouch Plus trunk accessory). Breast cancer and treatment in itself was an awful journey. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. stream 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.. << Having to search it all out including bandaging and reducing myself, learning from You Tube, finding supplies online and dealing with physical therapists and oncologists and radiation oncologists who dont know anything about this chronic disease and putting all the pieces together myself because there are people to help but no one knows where they are was emotially depressing. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /Subtype /Link For general information, Learn About Clinical Studies. stream To pump or not to pumpthat is a question that I hear in the lymphedema community. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. I only make 12k per year so its not like I can afford anything. 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. 4. 10 0 obj Im a pianist and its become my safe place. I really need this system and had such desperate hope. >> /MediaBox [0 0 612 792] >> I need help but theres a no return policy. >> They will reach out to Flexitouch in the process of creating a segment for the news. << 4 0 obj Explain the situation to them. >> (6Kjw_XGz'g &p 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. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. I have lymphedema in my right arm, breast and axilla. >> Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /Group << Lymphat Res Biol. 18 0 obj endobj The pump is called the Flexitouch System by Tactile Medical. 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. Tactile Systems Technology, Inc. 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. Faced with negative publicity, they often end up making things right. /TT1 50 0 R Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /MediaBox [0.0 0.0 612.0 792.0] This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. When I first went to physical therapy, she was running through some more common contibuters to swelling. /C2_0 54 0 R Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? Can I use the machine on lower limbs with compression garments above? 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. Flexitouch Plus Lymphedema Treatment of the Head and Neck A Registry to Evaluate the Flexitouch System and Flexitouch Plus for /Length 585 The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /S /URI 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. /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] HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 Then I got my flexitouch and my life changed. 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. /TT0 23 0 R The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation.
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