/TT0 69 0 R My husband?s pump system arrived yesterday. x I have a pump system left and right leg also stomach wraps. In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. Please write back in a month or so and let us know your progress. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. >> Then I got my flexitouch and my life changed. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. >> HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. /Font << I didnt make a decision to purchase a pump that day. 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. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /Rotate 0 I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. 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. /Im0 24 0 R My husband has a brand new system that Im trying to sell. /MediaBox [0 0 612 792] 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. /Length 412 It delivers a noninvasive therapy that patients can administer themselves at home. 14 0 obj An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. (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. It takes just 32 minutes per day. Head and Neck Cancer Lymphedema - Tactile Medical Flexitouch Pd32-u Lymphedema Treatment System Pump Negative value shows a increase in quality of life. Support Care Cancer (2020). It has made my life miserable. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Write a review. 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. Rz:MzI6 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. 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. << /Annots [39 0 R] /Resources << 2. /Type /Pages I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. endobj 2016;14(4):198205. >> >> Flexitouch Plus - Treat Head & Neck Swelling At Home with This The content is not intended to substitute manufacturer instructions. Has anyone else had any experience with this? 0 T Keep in touch! 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. /Type /Page YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /TT3 52 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. /TT0 23 0 R /Type /Action Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Thank you for writing. Toll-free: 1.833.3TACTILE (1.833.382.2845) Thumbs up for Flexi-Touch!! /CS /DeviceRGB Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. I am looking for a left arm garment for the flexitouch plus. Hi Wandalynn . I chatted with a woman from Tacoma and another from Idaho. /StructParents 0 Ridner, S.H., Dietrich, M.S., Deng, J. et al. For general information, Learn About Clinical Studies. Just wondering if you have any ideas of whom to contact on such a thing. stream {%AIqEWRA>, Negative value shows a decrease in quality of life/overall health. The woman from Idaho said her arm was softer and found the machine easy to use. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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 49 0 R A Pilot Study to Evaluate the Feasibility and Potential Effectiveness >> The woman from Idaho said her arm was softer and found the machine easy to use. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. Choosing to participate in a study is an important personal decision. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. During pregnancy (applies only to the Flexitouch Plus trunk accessory). For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. endstream /Type /Group See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use Hi Karyn, I will post your comment and see if Sarah still has the pump available. 15 0 obj >> %PDF-1.4 endobj Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Out of my sleeve, my 3/4 length sleeves arent as tight. endobj /CropBox [0.0 0.0 612.0 792.0] Lymphedema - Head and Neck Cancer Alliance 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. The pump has helped you achieve significant results. Hi Wally, Hope someone is able to meet your request. /Rotate 0 Text, image, video. Lymphat Res Biol. Material and methods Design and participants My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. endstream I know many others can as well. 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. << /TT3 74 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. stream They are usually called something like 7 on your side or Channel 3 helps you. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /MediaBox [0 0 612 792] Managing my lymphedema requires attention and an assortment of tools. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. 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 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. endobj 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. /Resources << /TT3 72 0 R I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) >> 4. 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. You have reached the maximum number of saved studies (100). I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /TT3 59 0 R 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. >> /TT0 22 0 R }3eIH]^p~>_ y#h`*#OPQB_lVI"p! 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. Negative value shows a decrease in pain. /Rotate 0 /A << Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. >> The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. /Type /Catalog /Parent 2 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. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. /F 4 endobj /TT1 50 0 R stream Lymphat Res Biol. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Positive value shows an increase in swelling. 3701 Wayzata Blvd, Suite 300 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. /ProcSet [/PDF /Text /ImageC] >> Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 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. Pain will be assessed using the VAS Pain Scale. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. It takes just 32 minutes per day. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. The pump is called the Flexitouch System by Tactile Medical. Flexitouch Plus - Tactile Medical /CS /DeviceRGB (Note: There are other well regarded pumps on the market. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /Rect [40.95 36 85.101 45.216] The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. Daily storage of Flextouch system - Lymphedema - Inspire 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. /Filter /FlateDecode Talk with your doctor and family members or friends about deciding to join a study. This is not anadvertisement for Flexitouch.). Learn More Take the steps now to help your head and neck cancer survivors. My skin appears more like the skin on my right arm. >> 3 0 obj 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 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 Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. /TT1 70 0 R 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. >> /Resources << Can I use the machine on lower limbs with compression garments above? 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. O ce they are used the government wont always them to use them on another. 1. 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. You have reached the maximum number of saved studies (100). I have been having weekly physical therapy to help with lymphedema and range of motion issues. /BS << 2015 51 (431-437), 1. The Flexitouch System is not used for nor intended for use to treat cellulitis. /Im0 60 0 R 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. /Subtype /Link ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. We were asked to improve the ease of donning . Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical . When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. Learn how your comment data is processed. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. https://doi.org/10.1007/s00520-020-05540-8, 3. JAMA Dermatol. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. For general information, Learn About Clinical Studies. 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. The whole process, though limiting my ambulation, was comfortable and relaxing. /TT2 71 0 R endobj 6 0 obj Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Muluk SC, Hirsch AT, Tafe EC. << 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.. /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] /Parent 2 0 R Try contacting different people. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. I wanted to talk to some people who had actually used the pump. Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com /MediaBox [0 0 612 792] >> I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 35 0 R] << 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. 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. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Type of Use (Select one or both, as applicable) lXI . Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. PDF Lauren Barnes - Food and Drug Administration HTo0~G6)BjH7u /Parent 2 0 R Another set of pads enveloped my left thigh and trunk. /CropBox [0 0 612 792] It has become so bad that I can barely walk. >> 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 . >> 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. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /Type /Page Keep sharing your story. Please cross your fingers for me that this works. /CropBox [0.0 0.0 612.0 792.0] Lymphat Res Biol, 2016. << /TT0 69 0 R [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. 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/. 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. Support Care Cancer (2020). Medical Device Innovation | Nottingham Spirk Design Collaborative /XObject << I cannot find any shoes that fit my feet or any pants that fit comfortably . << Thank you for sharing your husbands success with a pump. endobj All reviewers. A healthy lymphatic system moves lymph fluid throughout the body. My go to place when I need calming. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Thanks. Overview Product Features Details Benefits This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling.
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