flexitouch plus head and neck flexitouch plus head and neck

/TT0 56 0 R My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /Im0 24 0 R /Length 450 Out of my sleeve, my 3/4 length sleeves arent as tight. It delivers a noninvasive therapy that patients can administer themselves at home. /Contents 73 0 R It has become so bad that I can barely walk. Support Care Cancer (2020). Ive heard from many people that they saw good results with their pump. /MediaBox [0.0 0.0 612.0 792.0] /Rect [40.95 36 85.101 45.216] Tens of thousands of. /Contents 53 0 R /MediaBox [0.0 0.0 612.0 792.0] >> Minneapolis, MN 55416 USA /TT2 51 0 R 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. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. << /CropBox [0.0 0.0 612.0 792.0] The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. The pump is called the Flexitouch System by Tactile Medical. /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] One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. | Source: It delivers a noninvasive therapy that patients can administer themselves at home. Negative value shows a decrease in quality of life/overall health. << So its fairly new for sale, Let me know if the pump system and right and left leg with stomach wraps are still for sale. O ce they are used the government wont always them to use them on another. /Resources << Please remove one or more studies before adding more. I have little confidence that the FaceTime call offered will be of much use. I was told purchased high priced left garments which I dont think I needed. 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.. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. 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 >> In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. I chatted with a woman from Tacoma and another from Idaho. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. HTo0~G6)BjH7u >> 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! 5 0 obj The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. 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.. 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 just finished 6 weeks of radiation. Tactile Systems Technology, Inc. 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. >> /Annots [10 0 R 11 0 R 12 0 R] /TT0 69 0 R 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 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. 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 ] Its also a relief not to manually MLD my arm every night. /Type /Action If you still have the system, I am interested. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 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 . Adams, KE, Rasmussen JC, Darne C, et al. /StructParents 6 2015;151(11):11871193. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. /StructParents 2 Two years on pump controller and garments. /StructParents 7 Muluk SC, Hirsch AT, Tafe EC. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Flexitouch Pd32-u Lymphedema Treatment System Pump. For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. 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. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. /Filter /FlateDecode XJ My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. /Type /Group /Type /Group /Contents 75 0 R Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Lymphedema Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. 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. How customer reviews and ratings work See All Buying Options. /Type /Catalog Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. << 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.. /S /Transparency The chambers take turns filling up with air with the goal of moving excess fluid out of the affected limb and returning it to the cardiovascular system. 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. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. >> 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). The feeling of devloping a chronic disease after surviving cancer was almost debilitating. 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. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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. /CropBox [0.0 0.0 612.0 792.0] Its been tough . Negative value shows a increase in quality of life. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! /C2_0 21 0 R /Length 470 Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Learn how your comment data is processed. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? So for almost every night for the next seven years I sat down and performed MLD on my left arm. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. /ProcSet [/PDF /Text] For general information, Learn About Clinical Studies. 0 T Keep in touch! /Font << Ml6(|a\!A.;Q#[. /W 0 2. /ProcSet [/PDF /Text /ImageC] /Subtype /Link ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Tactile Systems Technology, Inc. /Rotate 0 Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment 2010; Vol. Choosing to participate in a study is an important personal decision. Phone: 1.612.355.5100 >> Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. << Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. endobj My therapist said they cannot be reused by another. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. Thank you for writing. Its something Im passionate about. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. If Im out late, I use it in the morning and then resume again in the evening. 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. 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 sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of 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. A healthy lymphatic system moves lymph fluid throughout the body. Study record managers: refer to the Data Element Definitions if submitting registration or results information. >> >> >> 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. 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. It takes just 32 minutes per day. /TT3 72 0 R NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. /Rotate 0 The head & neck of non-human animals - | Cambridge SMART Vocabulary Top reviews. /Font << 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. Actually they dont know much about lymphedema. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Faced with negative publicity, they often end up making things right. /Type /Action Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 1. Negative value shows a decrease in Function/Range of Motion. /CS /DeviceRGB Material and methods Design and participants /ExtGState << << Support Care Cancer (, 2020). (6Kjw_XGz'g &p Sign up today for your free Reader Account. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. >> /Filter /FlateDecode Flexitouch Plus provides flexible program options. /Parent 2 0 R /TT1 57 0 R All subjects will receive a single intervention. I decided to purchase one without insurance. I have a pump system left and right leg also stomach wraps. >> >> /Type /Page Since using the Flexitouch for almost a year, she had not experienced cellulitis. (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. 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. 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 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. /Tabs /S I need help but theres a no return policy. Text, image, video. All stars. Just wondering if you have any ideas of whom to contact on such a thing. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. 14(4): p. 198-205, 2. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. 12 0 obj I knew Dr. Stanley Rockson of Stanford University was performing a drug trial with a medication called Uberimex for the treatment of lymphedema so I was keenly interested in learning what he said about this new pump. Biomedical Optics Express. << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Thank you for sharing and being an advocate for lymphedema! (Note: There are other well regarded pumps on the market. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ /StructParent 1 /Group << The Flexitouch System and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema . Ridner, S.H., Dietrich, M.S., Deng, J. et al. /Parent 2 0 R Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /Length 412 /StructParents 0 I really need this system and had such desperate hope. /GS0 37 0 R Ive had my Flexitouch for almost five months. 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. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 14(4): p. 198-205. /BS << 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 Deng J, et al. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 14 0 obj << Study record managers: refer to the Data Element Definitions if submitting registration or results information. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) endobj stream /CS /DeviceRGB The whole process, though limiting my ambulation, was comfortable and relaxing. /Type /Page Venous Ulcers. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 1(1): 114125. Chronic Wounds 3701 Wayzata Blvd, Suite 300 )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv Any circumstance where increased lymphatic or venous return is undesirable endstream The woman from Idaho said her arm was softer and found the machine easy to use. 3 0 obj /TT1 70 0 R I have been suffering from lymphedema for the past 2 years. Michelin Man came to mind as I stretched out on the couch. * American Society of Clinical Oncology 1. /Resources << /Rotate 0 >> 3 total ratings, 2 with reviews There was a problem filtering reviews right now. History of the Northwest Lymphedema Center. 10 0 obj Keep sharing your story. >> 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! 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. Talk with your doctor and family members or friends about deciding to join a study. https://doi.org/10.1007/s00520-020-. Last updated March 2021. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. endobj Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. I would contact your local news station that has a consumer investigation/help line. I dont like that I have to do it but it has changed my legs back to normal. << 1. I cant explain that but I can visually see a difference. 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.