flexitouch plus head and neck

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 warranty was the same as a new machine. Thank you for sharing your husbands success with a pump. where is the compassion for ill people that NEED certain healthcare to get better? 3 0 obj 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. 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. stream 2016;14(4):198205. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Hi Karyn, I will post your comment and see if Sarah still has the pump available. My husband has a brand new system that Im trying to sell. 17 0 obj 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. I wanted to talk to some people who had actually used the pump. >> /TT0 69 0 R 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. /Resources << The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /Parent 2 0 R /StructParents 8 16 0 obj All subjects will receive a single intervention. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. 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. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. /Filter /FlateDecode << Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Type of Use (Select one or both, as applicable) lXI . Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Support Care Cancer (, 2020). /Filter /FlateDecode endobj 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. >> /MediaBox [0.0 0.0 612.0 792.0] Hi Deborah, How wonderful you have had such positive success with your pump. My insurance paid for all of it and the Tactile rep will help you get that. << A healthy lymphatic system moves lymph fluid throughout the body. Support Care Cancer (2020). Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. << /StructParents 0 /Parent 2 0 R /TT3 74 0 R He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /Im0 60 0 R 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 ] For more information, https://tactilemedical.com/about-us/. /Resources << I use it every evening. /Filter /FlateDecode /Parent 2 0 R /Type /Group >> The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . I can relate all too well to what you have been through. My thighs are so big that I can no longer Drive. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? Another set of pads enveloped my left thigh and trunk. /S /Transparency endstream Its something Im passionate about. /S /Transparency %PDF-1.4 An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Rockson floated to my ears. /TT1 70 0 R Minneapolis, MN 55416 USA It has become so bad that I can barely walk. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! JAMA Dermatol. doi.org/10.1007 /s00520-020-05540-8, First-ever randomized control trial of home management of head and neck lymphedema, Retrospective analysis of 205 Flexitouch user survey responses, Near-infrared fluorescence lymphatic imaging (NIRFLI) before and after Flexitouch use, Flexitouch Plus is the only FDA cleared pneumatic, See the clinical benefit of Flexitouch Plus, Longitudinal Patient Reported Outcomes Study. The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. Thank you for writing. I have lymphedema in my right arm, breast and axilla. I always start with the one hour full arm and core setting. 5 0 obj 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. It was a blow to the life I had that I once had. /TT3 52 0 R Positive value shows an decrease in quality of life. The head & neck of non-human animals - | Cambridge SMART Vocabulary Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Material and methods Design and participants Deng J, et al. It was up to me to piece it together. Free shipping for many products! Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. Hopefully it will give me a better quality of life because I dont know what else to do at this point. Why Should I Register and Submit Results? Im sorry for the experience you had with Tactile Medical. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. /Rect [90.257 252.64 421.33 266.44] And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> . I got my Flexibtouch plus system last week that I was never measured for so the whole system feels to big on me, Ive had to call customer service several times because I cant get it to run correctly, They have it set up on 104 min. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /Tabs /S 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. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. Buying a reconditioned machine saved me some money. endobj The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. /TT0 23 0 R Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. /Tabs /S For general information, Learn About Clinical Studies. 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. /TT0 69 0 R /Contents 75 0 R >> The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Support Care Cancer (2020). To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. They will reach out to Flexitouch in the process of creating a segment for the news. Numerous clinical studies show achievement of major clinical benefits and cost savings /A << /StructParents 2 /TT2 71 0 R She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. 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! stream >> I really need this system and had such desperate hope. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. 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.. H]O0+=) ES 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! 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. /Type /Pages 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 Ive had my Flexitouch for almost five months. I have skipped 1 or 2 days just 3 or 4 times since March. /Subtype /Link << I had a mastectomy and 9 lymph nodes removed 3 months ago. The woman from Idaho said her arm was softer and found the machine easy to use. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. The leg garments that I received are for a much taller person. 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^ Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Reading or watching TV are the activities Im able to do while Im being treated. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp 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 Flexitouch 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. /StructParent 1 << 9 0 obj The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. >> 2016;14(4):198205. /TT1 70 0 R Lymphedema Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. 10 0 obj 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. /StructParents 6 Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. 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. /Annots [39 0 R] Write a review. /TT0 22 0 R >> Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /Type /Action /Length 412 Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Hi Kathi, The FaceTime call might work! << 35 0 R] 11 0 obj Ive heard from many people that they saw good results with their pump. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. We rely on the generosity of individuals and sponsors who support our mission and activities. Its been tough . HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. They are programed for each individual. (6Kjw_XGz'g &p 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 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. Hi Kristie, Thank you for sharing your story. Support Care Cancer (2020). Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Rz:MzI6 To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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. /A << Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. /MediaBox [0.0 0.0 612.0 792.0] Its amazing to me how little doctors know about lymphedema. >> . Managing my lymphedema requires attention and an assortment of tools. /Font << For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Phone: 1.612.355.5100 Negative value shows a decrease in swelling. Hi Wandalynn . /CropBox [0.0 0.0 612.0 792.0] /Group << Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. 2013; Vol. 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. << 7 0 obj /MediaBox [0.0 0.0 612.0 792.0] /Tabs /S S The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /C2_0 38 0 R /Length 585 2. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. This is not anadvertisement for Flexitouch.). >> by Flexitouch. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Positive value shows an increase in symptoms/problems. UGH! First of all I cant drive, and second I have to pay a $60 copay every time I go. 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. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. Choosing to participate in a study is an important personal decision. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. /S /URI 2010; Vol. << endobj /MediaBox [0 0 612 792] See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use /ProcSet [/PDF /Text /ImageC] The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. I just finished 6 weeks of radiation. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. It delivers a noninvasive therapy that patients can administer themselves at home. stream My skin appears more like the skin on my right arm. 1(1): 114125. Im a pianist and its become my safe place. >> Your email address will not be published. /Length 470 Heart failure (acute pulmonary edema, decompensated acute heart failure) /Font << My husband?s pump system arrived yesterday. When I first went to physical therapy, she was running through some more common contibuters to swelling. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. /XObject << phone: +1 (623) 738-9011 (57) Webstore 3. Muluk SC, Hirsch AT, Tafe EC. You are benefiting the lymphedema community. << 3. /Filter /FlateDecode Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Explain the situation to them. I have been having weekly physical therapy to help with lymphedema and range of motion issues. (Note: There are other well regarded pumps on the market. My best to you. EJVES. * American Society of Clinical Oncology 1. << /TT2 72 0 R I use it everyday for an hour. She explained that compression pumps force air into sleeves with multiple chambers. My lymphedema therapist also told me that the pumps werent worth it. Except for my wrist, all my measurements showed reduction. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. All reviewers. did you sell it yet? /TT2 51 0 R You have reached the maximum number of saved studies (100). He just never could get use to using it and being able to don the garments. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. What is encouraging is that you have had success with managing your lymphedema! Thumbs up for Flexi-Touch!! Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. /C2_0 48 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 cant explain that but I can visually see a difference. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Biomedical Optics Express. /CropBox [0.0 0.0 612.0 792.0] 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 greatly encourage others to try to obtain one if they are able and if it is a good option for them. endstream stream 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. /Type /Page /StructParents 0 https://doi.org/10.1007/s00520-020-. The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). % /C2_1 55 0 R /A << 4 0 obj document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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