In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. >> /Resources << /C2_0 54 0 R 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. >> /W 0 /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. The content is not intended to substitute manufacturer instructions. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) >> To pump or not to pumpthat is a question that I hear in the lymphedema community. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /Filter /FlateDecode /BS << Positive value shows an increase in Function/Range of Motion. 5 0 obj 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. I use it everyday for an hour. /XObject << Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. * American Society of Clinical Oncology 1. /Type /Group I just received the flexitouch plus, but I think the leg garments are too big. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) 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. September 30, 2021 09:03 ET https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. /Tabs /S 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 . The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I just finished 6 weeks of radiation. Im sorry for the experience you had with Tactile Medical. 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. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /Resources << We were asked to improve the ease of donning . Minneapolis, MN 55416 USA Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. /TT1 57 0 R D/N500187-000-00 Rev. Toll-free: 1.833.3TACTILE (1.833.382.2845) Toll-free: 1.833.3TACTILE (1.833.382.2845) Negative value shows a decrease in quality of life/overall health. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. When she said piano I froze. I decided to purchase one without insurance. For more information, https://tactilemedical.com/about-us/. Positive value shows an increase in pain. 2015 51 (431-437), 1. Head and chest measurements within the following: Prescribed the Flexitouch system or Flexitouch Plus, Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression), Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness), Symptomatic bradycardia in the absence of a pacemaker, Internal jugular venous thrombosis (within 3 months), Increased intracranial pressure or other contraindications to internal or external jugular venous compression, Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative, Facial or head and neck dermal metastasis, Acute facial infection (e.g., facial or parotid gland abscess), Any condition in which increased venous and lymphatic return is undesirable, Heart failure (acute pulmonary edema, decompensated acute heart failure), Subject is pregnant or trying to become pregnant, Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism). 0 T Pain will be assessed using the VAS Pain Scale. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. /TT1 50 0 R The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. endobj Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Hi Kristie, Thank you for sharing your story. 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. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /TT3 52 0 R /A << 3 total ratings, 2 with reviews There was a problem filtering reviews right now. (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. /CS /DeviceRGB The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 1. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Ive heard from many people that they saw good results with their pump. I have a pump system left and right leg also stomach wraps. The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! Except for my wrist, all my measurements showed reduction. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. Rockson floated to my ears. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Rect [90.257 252.64 421.33 266.44] 9 0 obj (Clinical Trial). Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). 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 am looking for the leg and trunk model is that what you have? Oral Oncology. Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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 have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. Any circumstance where increased lymphatic or venous return is undesirable Hi Kathi, The FaceTime call might work! The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. Search. It delivers a noninvasive therapy that patients can administer themselves at home. O ce they are used the government wont always them to use them on another. /Parent 2 0 R They are in contact with patients who could benefit from a pneumatic pump. /MediaBox [0.0 0.0 612.0 792.0] Support Care Cancer (, 2020). phone: +1 (623) 738-9011 (57) Webstore 3. stream I have been having weekly physical therapy to help with lymphedema and range of motion issues. >> Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ 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. 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. 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. stream 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. Text, image, video. Buying a reconditioned machine saved me some money. The woman from Idaho said her arm was softer and found the machine easy to use. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . /Font << Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. I have little confidence that the FaceTime call offered will be of much use. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. Try contacting different people. /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R Karaca-Mandic P, Hirsch AT, Rockson SG, et al. >> It seems a lot of pumps are preprogrammed for the individual. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. Tens of thousands of. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) /Length 498 I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. endstream endobj G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp Its also a relief not to manually MLD my arm every night. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Lymphat Res Biol, 2016. Support Care Cancer (2020). Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) 7 0 obj PW!\v(jfz:yX 8$W"wqHbxQDL << endobj /TT1 23 0 R 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. /CropBox [0.0 0.0 612.0 792.0] My interest in pumps suddenly skyrocketed! My thighs are so big that I can no longer Drive. >> /StructParents 6 I did a baseline measurement of my left arm before treatment and three weeks after using the pump. >> The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. The pump is called the Flexitouch System by Tactile Medical. | Source: << << /Type /Catalog endstream 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. >> One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. /Subtype /Link /MediaBox [0.0 0.0 612.0 792.0] A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Type /Page 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! /F 4 /Parent 2 0 R 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. endobj Listing a study does not mean it has been evaluated by the U.S. Federal Government. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. 2010; Vol. >> My go to place when I need calming. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. endobj Talk with your doctor and family members or friends about deciding to join a study. k Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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) . A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. The woman from Idaho said her arm was softer and found the machine easy to use. >> Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. /F 4 Write a review. stream I am looking for a left arm garment for the flexitouch plus. For general information, Learn About Clinical Studies. >> Ideas? /CropBox [0.0 0.0 612.0 792.0] Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. (6Kjw_XGz'g &p Surprisingly, my therapists measurements showed minimal difference with previous measurements. >> I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. /Contents 36 0 R Lymphat Res Biol, 2016. Toll-free: 1.833.3TACTILE (1.833.382.2845) Hi Wally, Hope someone is able to meet your request. 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. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 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. /TT3 74 0 R Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /S /Transparency If Im out late, I use it in the morning and then resume again in the evening. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> I use it every evening. /ProcSet [/PDF /Text /ImageC] A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. >> I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /Tabs /S /Resources << /Type /Action All subjects will receive a single intervention. /XObject << /Rotate 0 /Tabs /S Please cross your fingers for me that this works. They use them in the morning, at nightand feel very lucky.. /Font << It delivers a noninvasive therapy that patients can administer themselves at home. /Type /Pages /S /URI 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 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. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 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. /C2_1 55 0 R Support Care Cancer (2020). Yes, taking care of ones body requires several interventions. 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. . 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. Negative value shows a decrease in pain. /StructParents 2 /Parent 2 0 R I did send them an email and asked them to look at your case again. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! K-ZB: /F 4 /Type /Page << 5. /Annots [39 0 R] The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. stream H]O0+=) ES Muluk SC, Hirsch AT, Tafe EC. Words like new kind of pump, different than the old types, favorable studies, and Dr. My husband?s pump system arrived yesterday. /Tabs /S Numerous clinical studies show achievement of major clinical benefits and cost savings 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. When I first went to physical therapy, she was running through some more common contibuters to swelling. >> /TT1 70 0 R endobj << Positive value shows an increase in swelling. /Type /Page 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. 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.. 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 Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. 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 leg garments that I received are for a much taller person. Its brand new, used 1 time. The head and neck garment set is easy to use and features the clinically proven Flexitouch technology that tens of thousands of lymphedema patients rely on every day to effectively treat their extremities. /Count 7 Lymphedema The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. She explained that compression pumps force air into sleeves with multiple chambers. Overview Product Features Details Benefits /Rotate 0 did you sell it yet? Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. Venous Ulcers. >> Rz:MzI6 /Resources << It has become so bad that I can barely walk. Subject Quality of Life will be assessed using EORTC C30 questionnaire. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Ive had my Flexitouch for almost five months. Thumbs up for Flexi-Touch!! /Rotate 0 >> /Parent 2 0 R The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. I really need this system and had such desperate hope. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. /GS0 37 0 R >> 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 dont like that I have to do it but it has changed my legs back to normal. It delivers a noninvasive therapy that patients can administer themselves at home. Its amazing how we are communicating so much more through technology because of Covid. Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment >> !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. I like to joke, Honey, time for me to put the squeeze on you 6 0 obj << Chronic Wounds . I dont know if it will make a difference. !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N They will reach out to Flexitouch in the process of creating a segment for the news. I have it in both of my legs mostly in my thighs. Its New, Your email address will not be published. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Percentage of each response captured. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling.