The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) My therapist said they cannot be reused by another. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. 1. I?m 5? It delivers a noninvasive therapy that patients can administer themselves at home. For general information, Learn About Clinical Studies. 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 /BS << Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. endstream Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment 2. /Subtype /Link 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. between head and neck cancer and lymphedema. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. /Type /Page Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Lymphat Res Biol, 2016. I have skipped 1 or 2 days just 3 or 4 times since March. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Hi Deborah, How wonderful you have had such positive success with your pump. /F 4 /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] * American Society of Clinical Oncology 1. Why Should I Register and Submit Results?
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. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. 1. 12 0 obj /Version /1.4 Buying a reconditioned machine saved me some money. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. 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 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. Yes, taking care of ones body requires several interventions. /Parent 2 0 R The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? . /S /URI Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /W 0
Tactile Medical Announces Enrollment of First Patient in They are in contact with patients who could benefit from a pneumatic pump. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /ProcSet [/PDF /Text /ImageC] 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.. Last updated March 2021. I would be interested to hear how your husbands experience with his new pump. /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. Negative value shows a decrease in swelling. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /CropBox [0 0 612 792]
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. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Subject Quality of Life will be assessed using EORTC C30 questionnaire. /Font << At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. I just received it yesterday and Im super hopeful that it will help. /Resources << Positive value shows an increase in quality of life/overall health. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. stream
1(1): 114125. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. 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. /TT3 59 0 R 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.
A Pilot Study to Evaluate the Feasibility and Potential Effectiveness /Tabs /S Then I got my flexitouch and my life changed. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Its New, Your email address will not be published. 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. 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..
A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Venous Ulcers. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. 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. Support Care Cancer (, 2020). Negative value shows a decrease in pain. /Type /Action >> Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Try contacting different people. It takes just 32 minutes per day. 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. 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. It delivers a noninvasive therapy that patients can administer themselves at home. (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. Swelling will be assessed using the ALOHA measurement protocol. Numerous clinical studies show achievement of major clinical benefits and cost savings >> The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Hopefully it will give me a better quality of life because I dont know what else to do at this point.
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. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. The pump is called the Flexitouch System by Tactile Medical. Learn More Take the steps now to help your head and neck cancer survivors. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[
Flexitouch Plus - Applying the Head and Neck Garment Set
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