endstream /ProcSet [/PDF /Text] Do you know of anyone whom would want to buy it? Flexitouch Plus Lymphedema Treatment of the Head and Neck Chronic Wounds In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. Choosing to participate in a study is an important personal decision. Tactile Systems debuts Flexitouch head and neck lymphedema treatment 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 Dr. Shelia Ridner Dr. Barbara Murphy I really need this system and had such desperate hope. 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. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Lymphedema Treatment in Head and Neck Cancer Patients Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. /Font << Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 4? Tactile Systems Technology, Inc. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Ive heard from many people that they saw good results with their pump. /A << Another set of pads enveloped my left thigh and trunk. endstream Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I just received the flexitouch plus, but I think the leg garments are too big. /Length 498 He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. /Rect [40.95 36 85.101 45.216] Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. 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. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /ProcSet [/PDF /Text] What really gripes me is that my nurse practitioner wouldnt even consider ordering one. 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. Both Ease of Use/Satisfaction will be assessed by survey. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. Its also a relief not to manually MLD my arm every night. 6 0 obj << /TT2 58 0 R 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. 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. Faced with negative publicity, they often end up making things right. 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. I wonder if pumps can be reprogrammed. 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. Adams, KE, Rasmussen JC, Darne C, et al. I did send them an email and asked them to look at your case again. Deng J, et al. It was up to me to piece it together. /Type /Page News Release Details - Tactile Systems Technology, Inc. I am looking for a left arm garment for the flexitouch plus. endobj (Note: There are other well regarded pumps on the market. The content is not intended to substitute manufacturer instructions. 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. Most significantly was the reduction in my forearm. 16 0 obj Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. << /ProcSet [/PDF /Text /ImageC] 3. /TT1 50 0 R Flexitouch Pd32-u Lymphedema Treatment System Pump. /TT0 49 0 R endobj Material and methods Design and participants Its brand new, used 1 time. << 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. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. They will reach out to Flexitouch in the process of creating a segment for the news. It takes just 32 minutes per day. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. View this study on Beta.ClinicalTrials.gov, 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. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. EJVES. /CropBox [0 0 612 792] /Type /Page Looking at his ankles there IS no swelling now. /Length 585 NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( /S /Transparency To pump or not to pumpthat is a question that I hear in the lymphedema community. /Im0 60 0 R To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Thank you for writing. x Minneapolis, MN 55416 USA /Contents 36 0 R document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. >> 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. She explained that compression pumps force air into sleeves with multiple chambers. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /ExtGState << 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. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 7 0 obj Hopefully it will give me a better quality of life because I dont know what else to do at this point. HTo0~G6)BjH7u >> 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 . Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Daily storage of Flextouch system - Lymphedema - Inspire History of the Northwest Lymphedema Center. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Yes. 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. /S /Transparency A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. I have skipped 1 or 2 days just 3 or 4 times since March. 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. /MediaBox [0 0 612 792] Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] /C2_0 54 0 R For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Lymphat Res Biol. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. endobj 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. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. >> My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 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! Michelin Man came to mind as I stretched out on the couch. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). /Parent 2 0 R I only make 12k per year so its not like I can afford anything. Flexitouch Pd32-u Lymphedema Treatment System Pump << /Resources << /CropBox [0.0 0.0 612.0 792.0] 2 0 obj 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. Support Care Cancer (, 2020). /MediaBox [0.0 0.0 612.0 792.0] I would be interested to hear how your husbands experience with his new pump. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! 2. /Group << (6Kjw_XGz'g &p >> Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. >> Oral Oncology. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. /Rotate 0 Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. 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. 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. 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/. /BS << 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. We rely on the generosity of individuals and sponsors who support our mission and activities. >> % 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. 4 0 obj JAMA Dermatol. endobj 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 >> Our Solutions for Head and Neck - Tactile Medical The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. content.edgar-online.com Ideas? Negative value shows a decrease in Function/Range of Motion. /Type /Page /Im0 24 0 R They use them in the morning, at nightand feel very lucky.. /Filter /FlateDecode And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. I have little confidence that the FaceTime call offered will be of much use. << Subject overall health and quality of life in the past week-EORTC C30. 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. /C2_0 38 0 R My therapist said they cannot be reused by another. >> 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. 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. Tactile Medical Announces Enrollment of First Patient in Minneapolis, MN 55416 USA Since using the Flexitouch for almost a year, she had not experienced cellulitis. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /S /URI << She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. Its been tough . I was told purchased high priced left garments which I dont think I needed. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. /Tabs /S /TT1 70 0 R >> 2016;14(4):198205.