Muluk SC, Hirsch AT, Tafe EC. 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. /Parent 2 0 R /A << 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 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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Version /1.4 2015;151(11):11871193. 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. 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.. HTo0~G6)BjH7u Dr. Shelia Ridner Dr. Barbara Murphy /StructParents 2 /Rect [40.95 36 85.101 45.216] /Count 7 Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. 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. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. /CropBox [0 0 612 792] 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. During pregnancy (applies only to the Flexitouch Plus trunk accessory). Ml6(|a\!A.;Q#[. endobj >> 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. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. For general information, Learn About Clinical Studies. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. /Contents 73 0 R Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. Medical Device Innovation | Nottingham Spirk Design Collaborative I have a uniboot compressions on both of my calves. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. /GS0 37 0 R Hi Kathi, The FaceTime call might work! 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. Overview Product Features Details Benefits The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. >> So we appealed 3 times. >> /F 4 Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. To pump or not to pumpthat is a question that I hear in the lymphedema community. Except for my wrist, all my measurements showed reduction. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. /Rotate 0 I use it every evening. 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. D/N500187-000-00 Rev. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /Resources << Flexitouch Pd32-u Lymphedema Treatment System Pump 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. 1(1): 114125. 14 0 obj 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. /TT0 22 0 R Thank you for writing. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Lymphat Res Biol. /Parent 2 0 R 5. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? My insurance paid for all of it and the Tactile rep will help you get that. /Subtype /Link endobj It delivers a noninvasive therapy that patients can administer themselves at home. /BS << 0 T The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. 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. >> HQK0)I46IC">bY3oons} K.4V./`\f0 Fs I always start with the one hour full arm and core setting. Numerous garment and program options to meet each patient's unique treatment needs endstream 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. % Why Should I Register and Submit Results? << I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. I have little confidence that the FaceTime call offered will be of much use. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. 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. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. >> I am looking for the leg and trunk model is that what you have? The content is not intended to substitute manufacturer instructions. I dont know if it will make a difference. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Im only 44 years old , and I have kids that need mom back. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. For more information, https://tactilemedical.com/about-us/. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. A healthy lymphatic system moves lymph fluid throughout the body. Keep sharing your story. 18 0 obj The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 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. The woman from Idaho said her arm was softer and found the machine easy to use. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. 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. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 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.. Thumbs up for Flexi-Touch!! As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /Type /Action My husband has a brand new system that Im trying to sell. 7 0 obj /W 0 /CS /DeviceRGB /Parent 2 0 R endstream Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, 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 skipped 1 or 2 days just 3 or 4 times since March. Out of my sleeve, my 3/4 length sleeves arent as tight. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. 7:00 a.m. to 7:00 p.m. CT, Monday through Friday and 8:00 a.m. to 12:00 p.m. CT, Saturday, 3701 Wayzata Blvd, Suite 300 /Pages 2 0 R Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. << . Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) endstream endobj >> Search. /MediaBox [0.0 0.0 612.0 792.0] Negative value shows a increase in quality of life. 1. I know many others can as well. Support Care Cancer (2020). My Experience with the Flexitouch Pneumatic Pump for Lymphedema The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. 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) . /Parent 2 0 R Upper set (head and neck). In this study, the investigators plan to treat the external lymphedema with a device called the Flexitouch Plus, which is already approved by the Food and Drug Administration (FDA) for lymphedema treatment, and to measure the degree of internal lymphedema using a pressure sensor to detect throat muscle pressure before and after the treatment with He just never could get use to using it and being able to don the garments. eIb? I decided to purchase one without insurance. Many, many of my patients love their pump. stream phone: +1 (623) 738-9011 (57) Webstore 3. 2016;14(4):198205. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 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. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. https://doi.org/10.1007/s00520-020-. Learn how your comment data is processed. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ /Filter /FlateDecode I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. We rely on the generosity of individuals and sponsors who support our mission and activities. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. 5 0 obj Choosing to participate in a study is an important personal decision. << I wish you success! Can I use the machine on lower limbs with compression garments above? Just wondering if you have any ideas of whom to contact on such a thing. ? /TT0 49 0 R With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. It seems a lot of pumps are preprogrammed for the individual. Positive value shows an decrease in quality of life. All subjects will receive a single intervention. /Contents 36 0 R 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 . 35 0 R] /Length 412 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. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Flexitouch System | Dynamic Compression | Home Therapy - WoundSource Since using the Flexitouch for almost a year, she had not experienced cellulitis. 3701 Wayzata Blvd, Suite 300 The feeling of devloping a chronic disease after surviving cancer was almost debilitating. << Words like new kind of pump, different than the old types, favorable studies, and Dr. 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. All stars. /Type /Page The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. >> 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 I would suggest you keep contacting Tactile Medical. 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. Swelling will be assessed using the ALOHA measurement protocol. Ideas? /Im0 24 0 R /Rotate 0 First of all I cant drive, and second I have to pay a $60 copay every time I go. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. (6Kjw_XGz'g &p 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! << /A << My lymphedema therapist also told me that the pumps werent worth it. /Subtype /Link /Tabs /S >> stream 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. /Im0 60 0 R /BS << 9 0 obj >> /Type /Page 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 was told purchased high priced left garments which I dont think I needed. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /XObject << History of the Northwest Lymphedema Center. /Group << Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Hopefully it will give me a better quality of life because I dont know what else to do at this point. << << Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. /TT1 70 0 R Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical EJVES. Toll-free: 1.833.3TACTILE (1.833.382.2845) My therapist said they cannot be reused by another. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. /StructParents 8 /Filter /FlateDecode G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Flexitouch Plus Lymphedema Treatment of the Head and Neck ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN /TT1 70 0 R I didnt make a decision to purchase a pump that day. /Annots [39 0 R] 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. Positive value shows an increase in symptoms/problems. /Tabs /S /Annots [10 0 R 11 0 R 12 0 R] I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Your email address will not be published. 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? JAMA Dermatol. I just received it yesterday and Im super hopeful that it will help. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. Lymphat Res Biol. PDF Lauren Barnes - Food and Drug Administration k /Type /Group Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) /CropBox [0.0 0.0 612.0 792.0] I cannot find any shoes that fit my feet or any pants that fit comfortably . >> O ce they are used the government wont always them to use them on another. Choosing to participate in a study is an important personal decision. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. 2. Minneapolis, MN 55416 USA << About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . /TT3 52 0 R Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /Font << 15 0 obj Type of Use (Select one or both, as applicable) lXI . Study record managers: refer to the Data Element Definitions if submitting registration or results information. /TT1 50 0 R September 30, 2021 09:03 ET News Release Details - Tactile Systems Technology, Inc.