Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /TT1 50 0 R I always start with the one hour full arm and core setting. Learn how your comment data is processed. Last updated March 2021. 1 0 obj /Resources << Ridner, S.H., Dietrich, M.S., Deng, J. et al. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /TT0 69 0 R >> /CropBox [0.0 0.0 612.0 792.0] /Rotate 0 In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 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. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /W 0 endobj To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. /BS << I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Subject overall health and quality of life in the past week-EORTC C30. (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. Positive value shows an increase in swelling. Pain will be assessed using the VAS Pain Scale. Adams, KE, Rasmussen JC, Darne C, et al. 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. /TT1 70 0 R << For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. endstream 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 I really need this system and had such desperate hope. /Rotate 0 Toll-free: 1.833.3TACTILE (1.833.382.2845) /S /Transparency /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] endobj I am looking for a left arm garment for the flexitouch plus. 8 0 obj Tens of thousands of. HTo0~G6)BjH7u 3701 Wayzata Blvd, Suite 300 Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Biomedical Optics Express. 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. endobj << Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] 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. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. Venous Ulcers. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. D/N500187-000-00 Rev. I would suggest you keep contacting Tactile Medical. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. 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? /TT3 59 0 R I cant explain that but I can visually see a difference. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /StructParents 8 /Tabs /S G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp /Resources << What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. 2013; Vol. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /TT1 23 0 R Im sorry for the experience you had with Tactile Medical. /S /URI 14(4): p. 198-205, 2. Both Ease of Use/Satisfaction will be assessed by survey. I use it every evening. 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. /Tabs /S The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. << 11 0 obj endstream /Type /Page I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Any circumstance where increased lymphatic or venous return is undesirable /Font << Lymphat Res Biol, 2016. /S /Transparency Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. >> >> 2016;14(4):198205. Toll-free: 1.833.3TACTILE (1.833.382.2845) She explained that compression pumps force air into sleeves with multiple chambers. Support Care Cancer (2020). /Type /Action >> Numerous clinical studies show achievement of major clinical benefits and cost savings Lymphat Res Biol. Its my new normal and Im thankful!! /CS /DeviceRGB }3eIH]^p~>_ y#h`*#OPQB_lVI"p! k >> endobj >> /CropBox [0.0 0.0 612.0 792.0] One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. /ProcSet [/PDF /Text] This is not anadvertisement for Flexitouch.). /Contents 75 0 R /C2_0 38 0 R /StructParents 7 eIb? Hi Kristie, Thank you for sharing your story. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. >> /Font << I was told purchased high priced left garments which I dont think I needed. Hi Jaime, Im hopeful that your new pump will provide relief. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. 2015;151(11):11871193. >> /A << While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. I cannot find any shoes that fit my feet or any pants that fit comfortably . 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. 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. Positive value shows an decrease in quality of life. 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! Study record managers: refer to the Data Element Definitions if submitting registration or results information. It delivers a noninvasive therapy that patients can administer themselves at home. /Type /Action Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. A healthy lymphatic system moves lymph fluid throughout the body. 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. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. 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 . 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. /Rotate 0 Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. endobj The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Has anyone else had any experience with this? Thanks. /MediaBox [0.0 0.0 612.0 792.0] 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. /Rect [40.95 36 85.101 45.216] HQK0)I46IC">bY3oons} K.4V./`\f0 Fs The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Call us at 1.833.3TACTILE (1-833-382-2845), 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. Its amazing how we are communicating so much more through technology because of Covid. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. 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. I just received the flexitouch plus, but I think the leg garments are too big. You have reached the maximum number of saved studies (100). Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. 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 am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. >> 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. /StructParents 2 Its brand new, used 1 time. /TT0 56 0 R The woman from Idaho said her arm was softer and found the machine easy to use. Thumbs up for Flexi-Touch!! /TT2 51 0 R /C2_0 48 0 R endobj Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Another set of pads enveloped my left thigh and trunk. September 30, 2021 09:03 ET Talk with your doctor and family members or friends about deciding to join a study. Actually they dont know much about lymphedema. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Choosing to participate in a study is an important personal decision. Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. /Type /Page 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. Ive always been diligent about caring for my lymphedema but if there was a product that could further the health of my left arm, I was going to investigate. 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. /Resources << Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. Yes. >> Sort by. /Parent 2 0 R /StructParents 0 Just wondering if you have any ideas of whom to contact on such a thing. 5 0 obj endstream The lymphedema seen in patients treated for head . /Resources << /Parent 2 0 R 2016;14(4):198205. Its New, Your email address will not be published. /Type /Group It has made my life miserable. Faced with negative publicity, they often end up making things right. We rely on the generosity of individuals and sponsors who support our mission and activities. When she said piano I froze. I have a pump system left and right leg also stomach wraps. https://doi.org/10.1007/s00520-020-. 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. >>
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