flexitouch plus head and neck

stream 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. 14(4): p. 198-205, 2. 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 /Catalog Hope it works out. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /Pages 2 0 R Overview Product Features Details Benefits 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. 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. For more information, https://tactilemedical.com/about-us/. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Deng J, et al. 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) Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. I use it every evening. I chatted with a woman from Tacoma and another from Idaho. /F 4 The content is not intended to substitute manufacturer instructions. 2. /Type /Group Tactile Medical Announces Enrollment of First Patient in - Yahoo! 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. >> /Length 450 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. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. 2 0 obj What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Flexitouch Plus provides flexible program options. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of 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. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. For general information, Learn About Clinical Studies. Lymphat Res Biol, 2016. Keep sharing your story. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. /BS << Minneapolis, MN 55416 USA document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. Study record managers: refer to the Data Element Definitions if submitting registration or results information. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. I have been suffering from lymphedema for the past 2 years. Michelin Man came to mind as I stretched out on the couch. /F 4 Rockson floated to my ears. /Rect [40.95 36 85.101 45.216] /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). The head & neck of non-human animals - | Cambridge SMART Vocabulary Flexitouch Plus - Tactile Medical As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) . content.edgar-online.com Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. For more information, https://tactilemedical.com/about-us/. /Parent 2 0 R History of the Northwest Lymphedema Center. Support Care Cancer (2020). Im only 44 years old , and I have kids that need mom back. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /Type /Page /ProcSet [/PDF /Text] Heart failure (acute pulmonary edema, decompensated acute heart failure) /CropBox [0.0 0.0 612.0 792.0] /Resources << Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. I didnt make a decision to purchase a pump that day. Tactile Medical braces for new Medicare rules that will tighten access 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. It has become so bad that I can barely walk. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Negative value shows a decrease in symptoms/problems. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Tactile Medical Announces Enrollment of First Patient in >> I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. by Flexitouch. I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. (6Kjw_XGz'g &p 3701 Wayzata Blvd, Suite 300 (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. I dont like that I have to do it but it has changed my legs back to normal. /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] 2016;14(4):198205. Oral Oncology. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Since using the Flexitouch for almost a year, she had not experienced cellulitis. 35 0 R] /TT1 70 0 R The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. /TT2 51 0 R /StructParents 7 All stars. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Choosing to participate in a study is an important personal decision. 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. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP For general information, Learn About Clinical Studies. 16 0 obj /Version /1.4 Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com They are in contact with patients who could benefit from a pneumatic pump. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Rz:MzI6 Flexitouch . Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. 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. 9 0 obj I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. 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. 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. 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. The pump has helped you achieve significant results. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. Minneapolis, MN 55416 USA endobj /TT3 72 0 R | Source: ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN 14(4): p. 198-205. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. Its amazing to me how little doctors know about lymphedema. /TT0 69 0 R Looking at his ankles there IS no swelling now. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. 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. >> Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. The head & neck of non-human animals - /Font << 17 0 obj In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Please remove one or more studies before adding more. 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. << Venous Ulcers. 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. /URI (http://www.fda.gov/) /Count 7 8 0 obj >> Karaca-Mandic P, Hirsch AT, Rockson SG, et al. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. /Filter /FlateDecode /Rotate 0 0 T 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. 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. The Flexitouch System is not used for nor intended for use to treat cellulitis. /Length 498 I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. >> 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. Positive value shows an increase in swelling. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational /Parent 2 0 R My Experience with the Flexitouch Pneumatic Pump for Lymphedema. /C2_0 38 0 R Toll-free: 1.833.3TACTILE (1.833.382.2845) endstream EJVES. Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. 10 0 obj 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 trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. 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. Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /C2_1 55 0 R /CropBox [0.0 0.0 612.0 792.0] I always start with the one hour full arm and core setting. /TT2 74 0 R /A << Its also a relief not to manually MLD my arm every night. 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. << Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Clinical Trial on Head and Neck Cancer: Flexitouch Plus system Search. Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. did you sell it yet? << Last updated March 2021. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. I have lymphedema in my right arm, breast and axilla. << Everything in my life that I do and love and I am passionate about invloves using my hands and arms. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. September 30, 2021 09:03 ET endstream 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /TT2 72 0 R /Tabs /S /Rotate 0 Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. I have been having weekly physical therapy to help with lymphedema and range of motion issues. Numerous clinical studies show achievement of major clinical benefits and cost savings You have reached the maximum number of saved studies (100). Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. 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. I am looking for a left arm garment for the flexitouch plus. Choosing to participate in a study is an important personal decision. Numerous garment and program options to meet each patient's unique treatment needs >> 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 ] /XObject << I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Ridner, S.H., Dietrich, M.S., Deng, J. et al. If Im out late, I use it in the morning and then resume again in the evening. 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. 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. Hi Deborah, How wonderful you have had such positive success with your pump. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. I dont know if it will make a difference. >> Two years on pump controller and garments. /TT3 52 0 R Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Developing Lymphedema and not being able to get the help that I neededwas awful. 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. How customer reviews and ratings work See All Buying Options. /XObject << /Font << /Contents 53 0 R 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. /Annots [39 0 R] Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. Toll-free: 1.833.3TACTILE (1.833.382.2845) endobj Has anyone else had any experience with this? Call us at 1.833.3TACTILE (1-833-382-2845), 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday. Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . /W 0 Managing my lymphedema requires attention and an assortment of tools. Flexitouch Plus Lymphedema Treatment of the Head and Neck Its New, Your email address will not be published. You have reached the maximum number of saved studies (100). The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use 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 The pump is called the Flexitouch System by Tactile Medical. >> Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) 12 0 obj >> Keep in touch! >> D/N500187-000-00 Rev. 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. /BS << Thank you for sharing your husbands success with a pump. << 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. 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. /Filter /FlateDecode 3. /Rotate 0 The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes.