Minneapolis, MN 55416 USA >> My husband has a brand new system that Im trying to sell. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. stream Im only 44 years old , and I have kids that need mom back. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. << As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. So we appealed 3 times. >> NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( 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. 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. >> I am looking for a left arm garment for the flexitouch plus. 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /Resources << I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. For general information, Learn About Clinical Studies. /Length 585 They are in contact with patients who could benefit from a pneumatic pump. /ProcSet [/PDF /Text] Search. /CropBox [0 0 612 792] 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. /Tabs /S /W 0 One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Rz:MzI6 They use them in the morning, at nightand feel very lucky.. 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.. /S /Transparency Ive had my Flexitouch for almost five months. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Free shipping for many products! Our Solutions for Head and Neck - Tactile Medical Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. All stars. https://doi.org/10.1007/s00520-020-05540-8, 3. 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. 2. So for almost every night for the next seven years I sat down and performed MLD on my left arm. /Parent 2 0 R /Contents 53 0 R endobj I just finished 6 weeks of radiation. /Type /Page /Type /Group /Pages 2 0 R In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Hi Deborah, How wonderful you have had such positive success with your pump. /A << It delivers a noninvasive therapy that patients can administer themselves at home. 12 0 obj I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /StructParents 2 ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. This is not anadvertisement for Flexitouch.). Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. Phone: 1.612.355.5100 This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. 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. Flexitouch Pd32-u Lymphedema Treatment System Pump Except for my wrist, all my measurements showed reduction. 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. Chronic Wounds stream The content is not intended to substitute manufacturer instructions. When she said piano I froze. /Rotate 0 I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. << Please write back in a month or so and let us know your progress. 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. I have it in both of my legs mostly in my thighs. /Filter /FlateDecode by Flexitouch. /Type /Page Positive value shows an increase in symptoms/problems. O ce they are used the government wont always them to use them on another. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /ProcSet [/PDF /Text /ImageC] 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. 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. << A Pilot Study to Evaluate the Feasibility and Potential Effectiveness 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. Out of my sleeve, my 3/4 length sleeves arent as tight. k /TT3 52 0 R Hi Kristie, Thank you for sharing your story. Looking at his ankles there IS no swelling now. /S /Transparency I dont know if it will make a difference. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. endstream 4 0 obj HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. It takes just 32 minutes per day. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 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. 1. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) 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.. >> Numerous clinical studies show achievement of major clinical benefits and cost savings >> Ridner, S.H., Dietrich, M.S., Deng, J. et al. /XObject << 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. /Type /Pages I just received it yesterday and Im super hopeful that it will help. Daily storage of Flextouch system - Lymphedema - Inspire tm233510-5_424b5 - none - 7.6719207s /URI (http://www.fda.gov/) 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. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Yay! A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. I really need this system and had such desperate hope. Numerous garment and program options to meet each patient's unique treatment needs Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /TT1 23 0 R The feeling of devloping a chronic disease after surviving cancer was almost debilitating. Phone: 1.612.355.5100 17 0 obj Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. endobj /TT0 23 0 R Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /TT3 74 0 R 3 0 obj /Rotate 0 PW!\v(jfz:yX 8$W"wqHbxQDL I only make 12k per year so its not like I can afford anything. 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 [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212. /ProcSet [/PDF /Text /ImageC] 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. 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 % /StructParents 0 They will reach out to Flexitouch in the process of creating a segment for the news. I have been having weekly physical therapy to help with lymphedema and range of motion issues. << 2. We rely on the generosity of individuals and sponsors who support our mission and activities. Tactile Medical Announces Enrollment of First Patient in Words like new kind of pump, different than the old types, favorable studies, and Dr. /S /URI Flexitouch Plus - Applying the Head and Neck Garment Set 7 0 obj In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. He just never could get use to using it and being able to don the garments. Venous Ulcers. My go to place when I need calming. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. 4? The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /Subtype /Link During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. << 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. I can relate all too well to what you have been through. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. You are benefiting the lymphedema community. 2015;151(11):11871193. 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. /TT0 22 0 R /ExtGState << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Material and methods Design and participants Study record managers: refer to the Data Element Definitions if submitting registration or results information. 46(4): 480487. Support Care Cancer (2020). I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. I have a uniboot compressions on both of my calves. For more information, https://tactilemedical.com/about-us/. 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. Support Care Cancer (, 2020). The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. /BS << >> My therapist said they cannot be reused by another. 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. I wonder if pumps can be reprogrammed. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. Clinical Trial on Head and Neck Cancer: Flexitouch Plus system /Tabs /S 0 T (Note: There are other well regarded pumps on the market. It has become so bad that I can barely walk. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. Dr. Shelia Ridner Dr. Barbara Murphy S 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. /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] The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? /W 0 How customer reviews and ratings work See All Buying Options. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] I was told purchased high priced left garments which I dont think I needed. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ My Experience with the Flexitouch Pneumatic Pump for Lymphedema. Negative value shows a decrease in symptoms/problems. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. 14(4): p. 198-205. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 info@nwlymphedemacenter.org. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 2. You have reached the maximum number of saved studies (100). << https://doi.org/10.1007/s00520-020-. It has made my life miserable. Sign up today for your free Reader Account. To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts /Im0 60 0 R I know many others can as well. /CS /DeviceRGB /C2_0 38 0 R Everything in my life that I do and love and I am passionate about invloves using my hands and arms. endobj The lymphedema seen in patients treated for head and neck cancer can be seen externally on the neck and face, as well as internally in the lining of the throat. (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. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Hope it works out. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? >> Thank you for writing. >> /Im0 24 0 R /Rect [40.95 36 85.101 45.216] >> Developing Lymphedema and not being able to get the help that I neededwas awful. /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] /StructParents 8 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. /MediaBox [0.0 0.0 612.0 792.0] /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] The whole process, though limiting my ambulation, was comfortable and relaxing. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. endobj eIb? Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. endstream I have little confidence that the FaceTime call offered will be of much use. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. /CropBox [0 0 612 792] /TT2 71 0 R {%AIqEWRA>, /S /URI I greatly encourage others to try to obtain one if they are able and if it is a good option for them. >> The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. I would contact your local news station that has a consumer investigation/help line. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) Has anyone else had any experience with this? >> 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. Talk with your doctor and family members or friends about deciding to join a study. 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/.
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