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 >> 15 0 obj /Font << (Clinical Trial). >> O ce they are used the government wont always them to use them on another. When I called my surgeon, he recommended that I not use the FlexiTouch on my chest because the compression can make the tissue expander rupture. /Rotate 0 It takes just 32 minutes per day. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Listing a study does not mean it has been evaluated by the U.S. Federal Government. /Type /Pages /Tabs /S I would be interested to hear how your husbands experience with his new pump. /Rotate 0 << >> Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Keep in touch! Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /Resources << The warranty was the same as a new machine. /Font << 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. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Ml6(|a\!A.;Q#[. You have reached the maximum number of saved studies (100). /CropBox [0 0 612 792] Ive heard from many people that they saw good results with their pump. >> Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. 1. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. /Resources << I was rather startled at how wrapped up I was. Upper set (head and neck). 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. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. I only make 12k per year so its not like I can afford anything. [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. 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. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. >> >> 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. 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. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. Hope it works out. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. endstream You have reached the maximum number of saved studies (100). Faced with negative publicity, they often end up making things right. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. 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! Flexitouch Plus Lymphedema Treatment of the Head and Neck /Im0 24 0 R Phone: 1.612.355.5100 Support Care Cancer (2020). 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. >> I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. endobj Lymphedema /Parent 2 0 R /TT1 70 0 R endobj >> Flexitouch Pd32-u Lymphedema Treatment System Pump It was a blow to the life I had that I once had. Tactile Medical braces for new Medicare rules that will tighten access Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Adams, KE, Rasmussen JC, Darne C, et al. The Head & Neck Program is just 32 minutes long. /Filter /FlateDecode /Tabs /S Filter by. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /S /Transparency 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) . /C2_0 38 0 R Ideas? I have lymphedema in my right arm, breast and axilla. First of all I cant drive, and second I have to pay a $60 copay every time I go. 2. 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. /TT3 52 0 R >> /S /Transparency I cant explain that but I can visually see a difference. Minneapolis, MN 55416 USA Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. << PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /TT2 58 0 R Reading or watching TV are the activities Im able to do while Im being treated. I always start with the one hour full arm and core setting. 3 0 obj Sort by. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 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. 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. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. 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 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. endobj It delivers a noninvasive therapy that patients can administer themselves at home. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Advanced Techniques in Canine and Feline Neurosurgery /CropBox [0.0 0.0 612.0 792.0] Last updated March 2021. (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. )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 /Type /Action Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /Subtype /Link I have a pump system left and right leg also stomach wraps. I have skipped 1 or 2 days just 3 or 4 times since March. Last updated March 2021. endobj PDF Lauren Barnes - Food and Drug Administration 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. I dont like that I have to do it but it has changed my legs back to normal. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. /Pages 2 0 R /TT2 72 0 R /Type /Action /Type /Page stream Talk with your doctor and family members or friends about deciding to join a study. /TT2 74 0 R Then I got my flexitouch and my life changed. endobj HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /C2_1 55 0 R 2. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Learn how your comment data is processed. << 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. I am delighted to say that hubbys minor leg swelling, from his diabetes and hefty build, are significantly less after Flexi-Touch was added to his health regime by the Diabetes Clinic at the VA Hospital. /CropBox [0.0 0.0 612.0 792.0] where is the compassion for ill people that NEED certain healthcare to get better? Please remove one or more studies before adding more. 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/. Chronic Wounds /Font << My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. /GS0 37 0 R Tactile Medical Announces Enrollment of First Patient in - Yahoo! /Rect [40.95 36 85.101 45.216] The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. /MediaBox [0 0 612 792] 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. /Type /Page I didnt make a decision to purchase a pump that day. /TT1 70 0 R Your email address will not be published. Managing my lymphedema requires attention and an assortment of tools. >> All subjects will receive a single intervention. I did send them an email and asked them to look at your case again. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. /Resources << They are in contact with patients who could benefit from a pneumatic pump. %PDF-1.4 endobj The pump is called the Flexitouch System by Tactile Medical. Support Care Cancer (2020). I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). /A << Minneapolis, MN 55416 USA 2013; Vol. eIb? Ive had my Flexitouch for almost five months. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. All stars. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. 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. /XObject << My lymphedema therapist also told me that the pumps werent worth it. endobj 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. Hopefully it will give me a better quality of life because I dont know what else to do at this point. Choosing to participate in a study is an important personal decision. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable.