/CropBox [0.0 0.0 612.0 792.0] /TT2 74 0 R For more information, https://tactilemedical.com/about-us/. Looking at his ankles there IS no swelling now. Toll-free: 1.833.3TACTILE (1.833.382.2845) Type of Use (Select one or both, as applicable) lXI . 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). Pembrolizumab plus cetuximab in patients with recurrent . 2 0 obj 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. If you still have the system, I am interested. The pump has helped you achieve significant results. >> >> Hi Kathi, The FaceTime call might work! /StructParent 1 >> S /Resources << They are programed for each individual. September 30, 2021 09:03 ET I have it in both of my legs mostly in my thighs. I dont like that I have to do it but it has changed my legs back to normal. All stars. I like to joke, Honey, time for me to put the squeeze on you Can I use the machine on lower limbs with compression garments above? History of the Northwest Lymphedema Center. You have reached the maximum number of saved studies (100). Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. /URI (http://www.fda.gov/) /W 0 /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. /StructParents 2 Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /Font << /TT0 56 0 R >> endstream /Type /Action Thank you for sharing your husbands success with a pump. /Rotate 0 /Pages 2 0 R My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Since using the Flexitouch for almost a year, she had not experienced cellulitis. phone: +1 (623) 738-9011 (57) Webstore 3. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) endobj /BS << HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. endstream >> The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. Material and methods Design and participants No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. << Yes. Since using the Flexitouch for almost a year, she had not experienced cellulitis. endobj The content is not intended to substitute manufacturer instructions. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) /A << /S /URI Positive value shows an increase in swelling. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. 2008-2023 HMP Global, Inc. All rights reserved. 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 ] Pain will be assessed using the VAS Pain Scale. 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. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. endstream Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. {%AIqEWRA>, << | Source: /Font << /Font << /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] In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Most significantly was the reduction in my forearm. /Type /Group To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. They will reach out to Flexitouch in the process of creating a segment for the news. Surprisingly, my therapists measurements showed minimal difference with previous measurements. The Head & Neck Program is just 32 minutes long. Ive heard from many people that they saw good results with their pump. I decided to purchase one without insurance. [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. It seems a lot of pumps are preprogrammed for the individual. 14(4): p. 198-205, 2. Chronic Wounds Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. The whole process, though limiting my ambulation, was comfortable and relaxing. /Font << Im a pianist and its become my safe place. Subject Quality of Life will be assessed using EORTC C30 questionnaire. 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. XJ I only make 12k per year so its not like I can afford anything. 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. /MediaBox [0.0 0.0 612.0 792.0] /Contents 73 0 R For general information, Learn About Clinical Studies. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. So we appealed 3 times. >> I am looking for the leg and trunk model is that what you have? Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. JAMA Dermatol. I am looking for a left arm garment for the flexitouch plus. >> Phone: 1.612.355.5100 Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. /Parent 2 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] . While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. The leg garments that I received are for a much taller person. stream 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! For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. /Length 585 /ProcSet [/PDF /Text /ImageC] /Rect [40.95 36 85.101 45.216] /Filter /FlateDecode /S /URI Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. I have skipped 1 or 2 days just 3 or 4 times since March. >> Both Ease of Use/Satisfaction will be assessed by survey. 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. I was rather startled at how wrapped up I was. Toll-free: 1.833.3TACTILE (1.833.382.2845) +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. >> The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /Length 450 I just finished 6 weeks of radiation. /Type /Pages /S /URI 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. >> /S /Transparency /Im0 60 0 R /Type /Group /MediaBox [0.0 0.0 612.0 792.0] 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) . I would suggest you keep contacting Tactile Medical. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 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. Its something Im passionate about. >> Hi Deborah, How wonderful you have had such positive success with your pump. /F 4 Yes, taking care of ones body requires several interventions. Last updated March 2021. 1. I have been suffering from lymphedema for the past 2 years. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. 46(4): 480487. 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. 2015;151(11):11871193. Adams, KE, Rasmussen JC, Darne C, et al. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The pump is called the Flexitouch System by Tactile Medical. where is the compassion for ill people that NEED certain healthcare to get better? I would be interested to hear how your husbands experience with his new pump. /W 0 In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. >> For more information, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/, Tactile Medical is a leader in developing and marketing at-home therapy devices that treat chronic swelling conditions such as lymphedema and chronic venous insufficiency. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) bic)xPt%Iss>2N'1`G fbpi&xFChr?T)=3@:uUe.kEK&{Ox0;b {*H / #w`pTP+vmA x{iy[ewq#):I)_CCQ.*oIw|o'ckU([:xzW% )8g&6 2:8P-j+c Its_vz;9~3CF!,Eu^F!'T{ J^ >> 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. Please cross your fingers for me that this works. /C2_0 38 0 R Ml6(|a\!A.;Q#[. Breast cancer and treatment in itself was an awful journey. I have little confidence that the FaceTime call offered will be of much use. 3 0 obj Please remove one or more studies before adding more. /Filter /FlateDecode >> >> 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 /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] Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Lymphat Res Biol, 2016. I always start with the one hour full arm and core setting. What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. 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. It was a blow to the life I had that I once had. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. stream 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. Negative value shows a decrease in swelling. Minneapolis, MN 55416 USA To pump or not to pumpthat is a question that I hear in the lymphedema community. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. We rely on the generosity of individuals and sponsors who support our mission and activities. I have been having weekly physical therapy to help with lymphedema and range of motion issues. 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . >> 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Many, many of my patients love their pump. Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] D/N500187-000-00 Rev. 1. 7nwJ@6]?t~.} Negative value shows a increase in quality of life. between head and neck cancer and lymphedema. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. endstream Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. endobj 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. It delivers a noninvasive therapy that patients can administer themselves at home. 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. 6 0 obj 4? My best to you. 13 0 obj endobj /Group << Numerous clinical studies show achievement of major clinical benefits and cost savings 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 addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Its also a relief not to manually MLD my arm every night. endobj Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) 0 T >> /Version /1.4 /Font << ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. /S /Transparency endobj >> My lymphedema therapist also told me that the pumps werent worth it. Minneapolis, MN 55416 USA stream 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. I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. endobj /TT0 69 0 R Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. The woman from Idaho said her arm was softer and found the machine easy to use. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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.
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