/Rect [90.257 252.64 421.33 266.44] Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /TT0 69 0 R 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 had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Managing my lymphedema requires attention and an assortment of tools. Talk with your doctor and family members or friends about deciding to join a study. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Surprisingly, my therapists measurements showed minimal difference with previous measurements. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 46(4): 480487. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. /Subtype /Link 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. Hi Wally, Hope someone is able to meet your request. 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 pump, created by Tactile Medical, provides compression to the skin which is a key to treating. 4 0 obj D/N500187-000-00 Rev. /TT0 69 0 R Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) 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! When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. 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. 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 . 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. 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. between head and neck cancer and lymphedema. /TT0 49 0 R /S /Transparency Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! When I first went to physical therapy, she was running through some more common contibuters to swelling. 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. 35 0 R] Lymphat Res Biol. It delivers a noninvasive therapy that patients can administer themselves at home. 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. Choosing to participate in a study is an important personal decision. 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. Find Pump Lymphedema Listings For Sale or Wanted On DOTmed.com Positive value shows an increase in Function/Range of Motion. /Parent 2 0 R Subject overall health and quality of life in the past week-EORTC C30. Support Care Cancer (2020). Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional HQK0)I46IC">bY3oons} K.4V./`\f0 Fs {%AIqEWRA>, /CropBox [0 0 612 792] Negative value shows a decrease in Function/Range of Motion. /Rotate 0 /S /URI Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /Type /Page 2 0 obj One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Pembrolizumab plus cetuximab in patients with recurrent . Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Flexitouch Plus - Applying the Head and Neck Garment Set /TT2 58 0 R << Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. If anyone has one, or knows of one, please contact me. /TT1 23 0 R 14(4): p. 198-205. I know many others can as well. % The Head & Neck Program is just 32 minutes long. 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. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /Font << Lymphat Res Biol. << x Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 2016;14(4):198205. 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. /StructParents 6 Ml6(|a\!A.;Q#[. Flexitouch . Sign up today for your free Reader Account. /Font << The Flexitouch Plus 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. 11 0 obj They use them in the morning, at nightand feel very lucky.. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Ive had my Flexitouch for almost five months. /MediaBox [0.0 0.0 612.0 792.0] >> /C2_0 38 0 R /CropBox [0.0 0.0 612.0 792.0] The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. 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. During pregnancy (applies only to the Flexitouch Plus trunk accessory). It delivers a noninvasive therapy that patients can administer themselves at home. You have reached the maximum number of saved studies (100). I just received it yesterday and Im super hopeful that it will help. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. I would contact your local news station that has a consumer investigation/help line. 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. /CropBox [0.0 0.0 612.0 792.0] 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. endstream /Font << I didnt need a lymphedema physical therapist but too much to explain here. does anyone know where I can find a size chart for the flexitouch garments so I can figure out what size I really am? Hopefully it will give me a better quality of life because I dont know what else to do at this point. 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! 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. /MediaBox [0.0 0.0 612.0 792.0] Study record managers: refer to the Data Element Definitions if submitting registration or results information. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. endobj /Type /Page /Font << Thanks. Negative value shows a decrease in pain. /Length 585 PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Hi Jaime, Im hopeful that your new pump will provide relief. endobj >> I have been suffering from lymphedema for the past 2 years. Refer to the Legal Notice for express terms of use. I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . It has made my life miserable. /Type /Catalog << endobj I am looking for a left arm garment for the flexitouch plus. Tens of thousands of. I chatted with a woman from Tacoma and another from Idaho. Daily storage of Flextouch system - Lymphedema - Inspire /URI (http://www.fda.gov/) endobj Ideas? /Tabs /S 1. >> /TT1 57 0 R /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] Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. Learn how your comment data is processed. Reading or watching TV are the activities Im able to do while Im being treated. /TT3 74 0 R Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Subtype /Link /ProcSet [/PDF /Text /ImageC] Head and chest measurements within the following: Prescribed the Flexitouch system or Flexitouch Plus, Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression), Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness), Symptomatic bradycardia in the absence of a pacemaker, Internal jugular venous thrombosis (within 3 months), Increased intracranial pressure or other contraindications to internal or external jugular venous compression, Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), or surgical flap less than 6-8 weeks post-operative, Facial or head and neck dermal metastasis, Acute facial infection (e.g., facial or parotid gland abscess), Any condition in which increased venous and lymphatic return is undesirable, Heart failure (acute pulmonary edema, decompensated acute heart failure), Subject is pregnant or trying to become pregnant, Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism). Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. 2. The lymphedema seen in patients treated for head . While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /BS << Developing Lymphedema and not being able to get the help that I neededwas awful. I still need to wear night garments and flat knit garmets and compression bras and self MLD but I feel like a weight has been lifted literally and physically. /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] >> /Group << >> 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 Swelling will be assessed using the ALOHA measurement protocol. 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 the Flexitouch Plus device. 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. 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch I have skipped 1 or 2 days just 3 or 4 times since March. Since using the Flexitouch for almost a year, she had not experienced cellulitis. 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. Buying a reconditioned machine saved me some money. /Type /Page See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use 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. Support Care Cancer (2020). /Type /Group /Length 498 >> endobj 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 What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Lymphat Res Biol, 2016. /ProcSet [/PDF /Text] Its amazing to me how little doctors know about lymphedema. 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. 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. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Choosing to participate in a study is an important personal decision. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. How customer reviews and ratings work See All Buying Options. stream The Flexitouch Plus system should not be used on patients with one or more of the following conditions: My lymphedema therapist also told me that the pumps werent worth it. >> endobj This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. 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.