flexitouch plus head and neck

/Length 680 /TT1 70 0 R << Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ The pump is called the Flexitouch System by Tactile Medical. I use it everyday for an hour. /W 0 << Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. stream According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. She explained that compression pumps force air into sleeves with multiple chambers. The lymphedema seen in patients treated for head . XJ Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. /URI (http://www.fda.gov/) The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. /Rect [90.257 252.64 421.33 266.44] /Font << /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /Rotate 0 All stars. k Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. My skin appears more like the skin on my right arm. )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv Type 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) Toll-free: 1.833.3TACTILE (1.833.382.2845) S I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Flexitouch Plus provides flexible program options. /TT2 71 0 R 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. /Tabs /S My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /MediaBox [0.0 0.0 612.0 792.0] I have had it some 10 years now and when it gets to the point of cellulitis I take medication which I feel is not the thing to do but it takes the pain away and eventually relieves the fever and some of the swelling. https://doi.org/10.1007/s00520-020-. I have one new for sale. So we appealed 3 times. Keep sharing your story. /Resources << The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. /Tabs /S I really need this system and had such desperate hope. & weigh 126 lbs. /CropBox [0.0 0.0 612.0 792.0] 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. /TT1 70 0 R /Length 450 Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. Support Care Cancer (2020). Try contacting different people. Choosing to participate in a study is an important personal decision. Support Care Cancer (, 2020). 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. At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. /F 4 My insurance paid for all of it and the Tactile rep will help you get that. 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. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. << 3. 6 0 obj [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. /C2_1 55 0 R Negative value shows a increase in quality of life. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Positive value shows an increase in quality of life/overall health. My best to you. /Parent 2 0 R /S /Transparency 15 0 obj /BS << D/N500187-000-00 Rev. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. >> stream I have been having weekly physical therapy to help with lymphedema and range of motion issues. >> /Subtype /Link 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. >> September 30, 2021 09:03 ET >> 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. {%AIqEWRA>, 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /S /URI Keep in touch! Its amazing to me how little doctors know about lymphedema. 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. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N /Rect [40.95 36 85.101 45.216] endobj 2. I cant explain that but I can visually see a difference. Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. Overview Product Features Details Benefits Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. Minneapolis, MN 55416 USA Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) 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. >> >> 8 0 obj >> The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. Talk with your doctor and family members or friends about deciding to join a study. I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. /TT3 74 0 R I use it every evening. Filter by. 2015;151(11):11871193. Text, image, video. Positive value shows an increase in swelling. Adams, KE, Rasmussen JC, Darne C, et al. PW!\v(jfz:yX 8$W"wqHbxQDL Information provided by (Responsible Party): 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. Please remove one or more studies before adding more. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. >> I dont like that I have to do it but it has changed my legs back to normal. /Im0 24 0 R 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. So for almost every night for the next seven years I sat down and performed MLD on my left arm. Its New, Your email address will not be published. K-ZB: Yes, taking care of ones body requires several interventions. 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. Its something Im passionate about. The pump has helped you achieve significant results. endobj Can I use the machine on lower limbs with compression garments above? /StructParent 1 /StructParents 0 Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) >> The warranty was the same as a new machine. The Flexitouch Plus 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. The woman from Idaho said her arm was softer and found the machine easy to use. Talk with your doctor and family members or friends about deciding to join a study. /TT2 72 0 R /Im0 60 0 R Its also a relief not to manually MLD my arm every night. Positive value shows an decrease in quality of life. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. >> In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. It delivers a noninvasive therapy that patients can administer themselves at home. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Parent 2 0 R Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Annots [10 0 R 11 0 R 12 0 R] I just received it yesterday and Im super hopeful that it will help. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. 1. 7 0 obj 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. Then I got my flexitouch and my life changed. 2008-2023 HMP Global, Inc. All rights reserved. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 2 0 obj Ideas? 7nwJ@6]?t~.} All reviewers. Hi Jaime, Im hopeful that your new pump will provide relief. 1. 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. << I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). A healthy lymphatic system moves lymph fluid throughout the body. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. It has become so bad that I can barely walk. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /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 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. /Length 470 << 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /StructParents 7 >> My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 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. Hi Kathi, The FaceTime call might work! It delivers a noninvasive therapy that patients can administer themselves at home. /Type /Action About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . /ProcSet [/PDF /Text /ImageC] Thank you for writing. endobj The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. | Source: >> Thank you for sharing your husbands success with a pump. 1(1): 114125. << I would be interested to hear how your husbands experience with his new pump. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /Font << YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. >> Reading or watching TV are the activities Im able to do while Im being treated. Learn how your comment data is processed. /BS << The pump is awesome works for me iam walking better @ standing the swelling goes away!!! /MediaBox [0 0 612 792] I always start with the one hour full arm and core setting. >> As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. /TT3 52 0 R (Note: There are other well regarded pumps on the market. /Pages 2 0 R /Parent 2 0 R 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. 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. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. I was told purchased high priced left garments which I dont think I needed. /Type /Page I wonder if pumps can be reprogrammed. Lymphat Res Biol, 2016. I am looking for the leg and trunk model is that what you have? The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. /S /Transparency /StructParents 0 4 0 obj Muluk SC, Hirsch AT, Tafe EC. Choosing to participate in a study is an important personal decision. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. /F 4 Last updated March 2021. Has anyone else had any experience with this? See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use /GS0 37 0 R Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. I?m 5? I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Biomedical Optics Express. /Filter /FlateDecode /W 0 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. It delivers a noninvasive therapy that patients can administer themselves at home. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp I didnt need a lymphedema physical therapist but too much to explain here. (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. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Sort by. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /C2_0 38 0 R 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. Hope it works out. /CropBox [0.0 0.0 612.0 792.0] For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. 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 am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Please remove one or more studies before adding more. You are benefiting the lymphedema community. /Group << 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. I can relate all too well to what you have been through. 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. >> /URI (http://www.fda.gov/) 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. 4? If Im out late, I use it in the morning and then resume again in the evening. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. I just finished 6 weeks of radiation. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /TT1 50 0 R It takes just 32 minutes per day. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating.

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