/Filter /FlateDecode 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. /C2_0 38 0 R << I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. The content is not intended to substitute manufacturer instructions. 2008-2023 HMP Global, Inc. All rights reserved. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN My Experience with the Flexitouch Pneumatic Pump for Lymphedema Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. Hopefully it will give me a better quality of life because I dont know what else to do at this point. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. Hi Karyn, I will post your comment and see if Sarah still has the pump available. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. >> O ce they are used the government wont always them to use them on another. /Tabs /S K-ZB: /Rotate 0 /Rect [90.257 252.64 421.33 266.44] 1(1): 114125. 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. Negative value shows a decrease in symptoms/problems. 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. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. Its amazing how we are communicating so much more through technology because of Covid. /Subtype /Link Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Daily storage of Flextouch system - Lymphedema - Inspire /Resources << Top reviews. 7 0 obj https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. /Length 470 does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? endstream >> Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Ml6(|a\!A.;Q#[. {%AIqEWRA>, My insurance company required me to use a different brand of compression pump and experience failure before they would consider covering the cost of a Flexitouch. To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. 3. 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 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) . 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! Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. stream Lymphat Res Biol. << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Flexitouch Plus - Applying the Head and Neck Garment Set /Group << /ProcSet [/PDF /Text /ImageC] 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. Both Ease of Use/Satisfaction will be assessed by survey. There is more to the whole story but bottom line is if you have this machine it changes everything they think they know about lymphedema! The Flexitouch Plus system should not be used on patients with one or more of the following conditions: Rockson floated to my ears. Ideas? /Parent 2 0 R 2 0 obj 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.. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Lymphedema - Head and Neck Cancer Alliance >> Last updated March 2021. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Last updated March 2021. 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 Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. /Pages 2 0 R I need help but theres a no return policy. 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 . )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 I greatly encourage others to try to obtain one if they are able and if it is a good option for them. We were asked to improve the ease of donning . /Rotate 0 /Tabs /S /TT0 22 0 R The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Advanced pneumatic compression for treatment of lymphedema of the head 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 awesome works for me iam walking better @ standing the swelling goes away!!! 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. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /Resources << Support Care Cancer (, 2020). /TT1 70 0 R << I have lymphedema near globally at this point and am trying to obtain coverage via insurance. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Venous Ulcers. Lymphedema When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Choosing to participate in a study is an important personal decision. >> Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. Filter by. /CropBox [0.0 0.0 612.0 792.0] /Tabs /S I have lymphedema in my right arm, breast and axilla. /BS << It delivers a noninvasive therapy that patients can administer themselves at home. You are benefiting the lymphedema community. /Rotate 0 /CropBox [0.0 0.0 612.0 792.0] Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /S /URI /Contents [13 0 R 14 0 R 15 0 R 16 0 R 17 0 R 18 0 R 19 0 R 20 0 R] << Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /A << Text, image, video. HTo0~G6)BjH7u Flexitouch Plus Lymphedema Treatment of the Head and Neck /MediaBox [0 0 612 792] >> Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. A Pilot Study to Evaluate the Feasibility and Potential Effectiveness 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. Tactile Medical braces for new Medicare rules that will tighten access 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. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). >> The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. 5 0 obj Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. endobj Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. Ridner, S.H., Dietrich, M.S., Deng, J. et al. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. 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 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. Tactile Medical Announces Enrollment of First Patient in Since using the Flexitouch for almost a year, she had not experienced cellulitis. Flexitouch . I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 3701 Wayzata Blvd, Suite 300 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. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. I really need this system and had such desperate hope. News Release Details - Tactile Systems Technology, Inc. The head & neck of non-human animals - >> I would suggest you keep contacting Tactile Medical. >> /Font << /TT1 23 0 R /CS /DeviceRGB << (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. Looking at his ankles there IS no swelling now. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. (Note: There are other well regarded pumps on the market. The pump has helped you achieve significant results. /CS /DeviceRGB Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 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. Im a pianist and its become my safe place. << As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Sign up today for your free Reader Account. Talk with your doctor and family members or friends about deciding to join a study. https://doi.org/10.1007/s00520-020-. Rz:MzI6 /Rect [40.95 36 85.101 45.216] The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. 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. I cannot find any shoes that fit my feet or any pants that fit comfortably . Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /Resources << 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. /Filter /FlateDecode https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /A << /Font << 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. /S /URI Your email address will not be published. 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. /MediaBox [0.0 0.0 612.0 792.0] Please remove one or more studies before adding more. 3701 Wayzata Blvd, Suite 300 endobj Deng J, et al. >> Its my new normal and Im thankful!! I cant explain that but I can visually see a difference. << /Type /Group 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. 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. 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. /TT3 59 0 R They are programed for each individual. 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. 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. Since using the Flexitouch for almost a year, she had not experienced cellulitis. 16 0 obj I am looking for a left arm garment for the flexitouch plus. Positive value shows an increase in symptoms/problems. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Toll-free: 1.833.3TACTILE (1.833.382.2845) Positive value shows an increase in Function/Range of Motion. Its been tough . Medical Device Innovation | Nottingham Spirk Design Collaborative Percent change is calculated by the difference between scores averaged at 6 months versus baseline. >> Flexitouch System | Dynamic Compression | Home Therapy - WoundSource 4. I did send them an email and asked them to look at your case again. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. Hi Jaime, Im hopeful that your new pump will provide relief. When I first went to physical therapy, she was running through some more common contibuters to swelling. The lymphedema seen in patients treated for head . 14(4): p. 198-205. /Contents 36 0 R >> Chronic Wounds This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. >> >> You have reached the maximum number of saved studies (100). Toll-free: 1.833.3TACTILE (1.833.382.2845) /W 0 /Filter /FlateDecode 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. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. Material and methods Design and participants Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. /Resources << >> Flexitouch Pd32-u Lymphedema Treatment System Pump. 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. /StructParents 7 Positive value shows an increase in swelling. endobj Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. I only make 12k per year so its not like I can afford anything. Two years on pump controller and garments. It takes just 32 minutes per day. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch 2. /StructParents 0 Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Ridner, S.H., Dietrich, M.S., Deng, J. et al. What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Tactile Systems Technology, Inc. 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. I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. Minneapolis, MN 55416 USA Faculty Innovators: Sheila Ridner and Barbara Murphy spearhead trials My husband?s pump system arrived yesterday. Flexitouch Pd32-u Lymphedema Treatment System Pump ? stream Study record managers: refer to the Data Element Definitions if submitting registration or results information. As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. 2016;14(4):198205. /GS0 37 0 R 13 0 obj endobj Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /F 4 Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. 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/. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. /Type /Action endobj See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 What is encouraging is that you have had success with managing your lymphedema! If you still have the system, I am interested. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Can I use the machine on lower limbs with compression garments above? 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. Required fields are marked *. She explained that compression pumps force air into sleeves with multiple chambers. It delivers a noninvasive therapy that patients can administer themselves at home. XJ << 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. For general information, Learn About Clinical Studies. 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. PDF Lauren Barnes - Food and Drug Administration I did a baseline measurement of my left arm before treatment and three weeks after using the pump. Biomedical Optics Express. /F 4 endobj << To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. Support Care Cancer (2020). /Resources << Tactile Systems Technology (TCMD +0.6%) announces the enrollment of the first patient in a randomized, controlled trial evaluating the effectiveness of its Flexitouch Plus system for the treatment . Michelin Man came to mind as I stretched out on the couch. https://doi.org/10.1007/s00520-020-05540-8, 3. 1 0 obj /Filter /FlateDecode Search. /TT3 52 0 R I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Refer to the Legal Notice for express terms of use. If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? /Rect [40.95 36 85.101 45.216] Keep sharing your story. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. /BS << During pregnancy (applies only to the Flexitouch Plus trunk accessory). Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical If Im out late, I use it in the morning and then resume again in the evening. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /Type /Page Thanks. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Please cross your fingers for me that this works. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment << Numerous garment and program options to meet each patient's unique treatment needs 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. For more information, https://tactilemedical.com/about-us/.