HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 >> endobj /Type /Group 3 total ratings, 2 with reviews There was a problem filtering reviews right now. /Rotate 0 The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. I am looking for the leg and trunk model is that what you have? 18 0 obj Minneapolis, MN 55416 USA /Type /Page /Resources << 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. Tens of thousands of. /Type /Action Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Its my new normal and Im thankful!! /Tabs /S /Contents 75 0 R eIb? >> They are in contact with patients who could benefit from a pneumatic pump. /ProcSet [/PDF /Text /ImageC] Most significantly was the reduction in my forearm. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. Thank you for sharing and being an advocate for lymphedema! 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. Surprisingly, my therapists measurements showed minimal difference with previous measurements. /Resources << 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. /Type /Pages The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. 1. >> 10 0 obj Just wondering if you have any ideas of whom to contact on such a thing. I just received the flexitouch plus, but I think the leg garments are too big. /Parent 2 0 R << Required fields are marked *. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Lymphat Res Biol, 2016. /Rotate 0 /Font << /Subtype /Link << Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. The head & neck of non-human animals - /W 0 content.edgar-online.com No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. I used it a few times and Im good now. /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] /Tabs /S /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. I dont know if it will make a difference. /Tabs /S /BS << /S /Transparency Thank you for sharing your husbands success with a pump. 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. << Actually they dont know much about lymphedema. /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 Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /Rotate 0 I need help but theres a no return policy. Phone: 1.612.355.5100 Hi Kristie, Thank you for sharing your story. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. /Resources << /TT0 49 0 R Its also a relief not to manually MLD my arm every night. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical 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! What is encouraging is that you have had success with managing your lymphedema! Negative value shows a decrease in quality of life/overall health. 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. >> /C2_1 55 0 R 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. Reading or watching TV are the activities Im able to do while Im being treated. << 14(4): p. 198-205, 2. /Rect [90.257 252.64 421.33 266.44] Deng J, et al. A Registry to Evaluate the Flexitouch System and Flexitouch Plus for If anyone has one, or knows of one, please contact me. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 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. endstream Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment Minneapolis, MN 55416 USA I greatly encourage others to try to obtain one if they are able and if it is a good option for them. 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. /Parent 2 0 R 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. Im sorry for the experience you had with Tactile Medical. >> Pembrolizumab plus cetuximab in patients with recurrent . /Rotate 0 5. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Flexitouch . The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. Im only 44 years old , and I have kids that need mom back. PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and I have lymphedema in my right arm, breast and axilla. It delivers a noninvasive therapy that patients can administer themselves at home. Tactile Systems Technology, Inc. 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) It was up to me to piece it together. did you sell it yet? Subject Quality of Life will be assessed using EORTC C30 questionnaire. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 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. View this study on Beta.ClinicalTrials.gov, 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. ? 3701 Wayzata Blvd, Suite 300 Out of my sleeve, my 3/4 length sleeves arent as tight. /Filter /FlateDecode /CropBox [0 0 612 792] 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/. /Type /Group It seems a lot of pumps are preprogrammed for the individual. Sort by. During pregnancy (applies only to the Flexitouch Plus trunk accessory). >> The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. I cant explain that but I can visually see a difference. Pain will be assessed using the VAS Pain Scale. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Thanks. >> 2. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. I did send them an email and asked them to look at your case again. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) >> /TT0 56 0 R I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. I?m 5? 8 0 obj For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. I have skipped 1 or 2 days just 3 or 4 times since March. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. tm233510-5_424b5 - none - 7.6719207s Its New, Your email address will not be published. Heart failure (acute pulmonary edema, decompensated acute heart failure) Explain the situation to them. /CropBox [0 0 612 792] 2010; Vol. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. >> Sci-Hub | Pembrolizumab plus cetuximab in patients with recurrent or Choosing to participate in a study is an important personal decision. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. >> /TT3 72 0 R Your email address will not be published. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. I just received it yesterday and Im super hopeful that it will help. 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. The head & neck of non-human animals - | Cambridge SMART Vocabulary My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help 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. Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use Flexitouch Plus - Applying the Head and Neck Garment Set endobj >> << 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 She explained that compression pumps force air into sleeves with multiple chambers. x I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. I like to joke, Honey, time for me to put the squeeze on you Flexitouch System | Dynamic Compression | Home Therapy - WoundSource {%AIqEWRA>, /TT1 70 0 R /Length 412 My lymphedema therapist also told me that the pumps werent worth it. /Tabs /S I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). endobj https://doi.org/10.1007/s00520-020-. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. . Search. >> /Length 680 4 0 obj 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. /TT2 74 0 R Listing a study does not mean it has been evaluated by the U.S. Federal Government. endstream To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Study record managers: refer to the Data Element Definitions if submitting registration or results information. /Contents 36 0 R Toll-free: 1.833.3TACTILE (1.833.382.2845) /Im0 24 0 R I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /CS /DeviceRGB (Note: There are other well regarded pumps on the market. 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. It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. /Font << endobj Another set of pads enveloped my left thigh and trunk. /Rect [40.95 36 85.101 45.216] by Flexitouch. /TT0 69 0 R For more information, https://tactilemedical.com/about-us/. 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.. 2. XJ !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ /MediaBox [0 0 612 792] He just never could get use to using it and being able to don the garments. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Overview Product Features Details Benefits I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. It takes just 32 minutes per day. Head and chest measurements within the following: Prescribed the Flexitouch system or Flexitouch Plus, Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression), Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness), Symptomatic bradycardia in the absence of a pacemaker, Internal jugular venous thrombosis (within 3 months), Increased intracranial pressure or other contraindications to internal or external jugular venous compression, Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative, Facial or head and neck dermal metastasis, Acute facial infection (e.g., facial or parotid gland abscess), Any condition in which increased venous and lymphatic return is undesirable, Heart failure (acute pulmonary edema, decompensated acute heart failure), Subject is pregnant or trying to become pregnant, Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism). O ce they are used the government wont always them to use them on another. For general information, Learn About Clinical Studies. Numerous clinical studies show achievement of major clinical benefits and cost savings Hi Wandalynn . Ive always been diligent about caring for my lymphedema but if there was a product that could further the health of my left arm, I was going to investigate. /A << The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N >> /Resources << History of the Northwest Lymphedema Center. A Pilot Study to Evaluate the Feasibility and Potential Effectiveness 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. You have reached the maximum number of saved studies (100). endobj /C2_0 38 0 R The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Of the patients who tried the device, 88% saw a reduction in head and neck swelling after an initial 32-minute at-home treatment with the Flexitouch system, and 89% of patients reported. /Type /Catalog The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. D/N500187-000-00 Rev. & weigh 126 lbs. 12 0 obj Lymphat Res Biol, 2016. 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. 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. 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. Yes. 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. 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.. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /Filter /FlateDecode This is a long story but I have managed it as best as I can but when I finally was ready to prove to my insurance that the Flexitouch was needed the insurance denied me coverage. << Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /Parent 2 0 R /F 4 September 30, 2021 09:03 ET I didnt need a lymphedema physical therapist but too much to explain here. /C2_0 48 0 R >> NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( My therapist said they cannot be reused by another. /ProcSet [/PDF /Text] And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. /CropBox [0.0 0.0 612.0 792.0] /Type /Page /URI (http://www.fda.gov/) Support Care Cancer (2020). (Clinical Trial). I always start with the one hour full arm and core setting. 3701 Wayzata Blvd, Suite 300 Minneapolis, MN 55416 USA To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Toll-free: 1.833.3TACTILE (1.833.382.2845) << I wanted to talk to some people who had actually used the pump. I dont like that I have to do it but it has changed my legs back to normal. 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. All subjects will receive a single intervention. Muluk SC, Hirsch AT, Tafe EC. /CS /DeviceRGB 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. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. /TT1 70 0 R PW!\v(jfz:yX 8$W"wqHbxQDL 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. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. Our Solutions for Head and Neck - Tactile Medical >> 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. It delivers a noninvasive therapy that patients can administer themselves at home. 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.