flexitouch plus head and neck

Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. 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. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. /ExtGState << 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) Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Study record managers: refer to the Data Element Definitions if submitting registration or results information. /TT1 23 0 R September 30, 2021 09:03 ET 7nwJ@6]?t~.} 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. 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. /Length 585 Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational )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 In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Lymphedema is a chronic disease that causes fluid buildup in the body and can complicate normal functions. Minneapolis, MN 55416 USA Karaca-Mandic P, Hirsch AT, Rockson SG, et al. I only make 12k per year so its not like I can afford anything. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. Do you know of anyone whom would want to buy it? Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. 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. /TT2 51 0 R Rockson floated to my ears. History of the Northwest Lymphedema Center. >> I cannot find any shoes that fit my feet or any pants that fit comfortably . 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. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Explain the situation to them. When she said piano I froze. Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. 4. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 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. /MediaBox [0 0 612 792] It has become so bad that I can barely walk. /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] 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. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! /Type /Page 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. Numerous garment and program options to meet each patient's unique treatment needs 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/. /C2_0 21 0 R /Contents 36 0 R Out of my sleeve, my 3/4 length sleeves arent as tight. Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Positive value shows an decrease in quality of life. 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 [email protected]. /Length 680 /Type /Action I wish you success! Negative value shows a decrease in quality of life/overall health. I just finished 6 weeks of radiation. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /Parent 2 0 R /Length 450 I dont like that I have to do it but it has changed my legs back to normal. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. >> Percentage of each response captured. /S /URI With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. & weigh 126 lbs. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. >> 3 0 obj She explained that compression pumps force air into sleeves with multiple chambers. 1. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. >> I am on a fixed income and have to pay almost 1K for something that Tactile Medical SHOULD have measured fortheyre the experts and SHOULD have measured correctly. 18 0 obj Toll-free: 1.833.3TACTILE (1.833.382.2845) /Group << Thumbs up for Flexi-Touch!! I greatly encourage others to try to obtain one if they are able and if it is a good option for them. I have been suffering from lymphedema for the past 2 years. /XObject << Since using the Flexitouch for almost a year, she had not experienced cellulitis. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. 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. Hi Kristie, Thank you for sharing your story. I was told purchased high priced left garments which I dont think I needed. ? 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. 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. endobj Lymphat Res Biol. Thank you for sharing your husbands success with a pump. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Positive value shows an increase in quality of life/overall health. endstream All reviewers. Michelin Man came to mind as I stretched out on the couch. /Rotate 0 My interest in pumps suddenly skyrocketed! I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. The content is not intended to substitute manufacturer instructions. /Type /Catalog >> Its amazing how we are communicating so much more through technology because of Covid. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. stream Hi Deborah, How wonderful you have had such positive success with your pump. /StructParents 0 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 It has made my life miserable. /Annots [39 0 R] /URI (http://www.fda.gov/) 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. stream /Im0 24 0 R Its something Im passionate about. They are programed for each individual. Keep in touch! Refer to the Legal Notice for express terms of use. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. Muluk SC, Hirsch AT, Tafe EC. Ive had my Flexitouch for almost five months. Positive value shows an increase in pain. /Subtype /Link !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. It delivers a noninvasive therapy that patients can administer themselves at home. Sort by. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Most significantly was the reduction in my forearm. endobj 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. Reading or watching TV are the activities Im able to do while Im being treated. Except for my wrist, all my measurements showed reduction. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. 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! If you dont mind, would you be willing to tell me what insurance company you have because it sounds like they were willing to help you? /TT2 71 0 R Actually they dont know much about lymphedema. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. I always start with the one hour full arm and core setting. 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. /W 0 If anyone has one, or knows of one, please contact me. /TT1 57 0 R /Resources << 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 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. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Deng J, et al. Can I use the machine on lower limbs with compression garments above? endstream What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /A << 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. /CS /DeviceRGB /Contents 53 0 R /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 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. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. I use it every evening. Both Ease of Use/Satisfaction will be assessed by survey. /Tabs /S >> Im sorry for the experience you had with Tactile Medical. 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.. Dr. Shelia Ridner Dr. Barbara Murphy I am looking for the leg and trunk model is that what you have? I was rather startled at how wrapped up I was. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. >> /Contents 73 0 R Choosing to participate in a study is an important personal decision. /ProcSet [/PDF /Text /ImageC] 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 . /Rotate 0 Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /TT1 70 0 R endstream I just received the flexitouch plus, but I think the leg garments are too big. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) 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. >> /TT0 56 0 R Lymphat Res Biol. I?m 5? /Parent 2 0 R Minneapolis, MN 55416 USA I cant explain that but I can visually see a difference. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. /BS << Its brand new, used 1 time. 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. When I first went to physical therapy, she was running through some more common contibuters to swelling. Heart failure (acute pulmonary edema, decompensated acute heart failure) /TT0 69 0 R 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. /Annots [10 0 R 11 0 R 12 0 R] Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? >> I didnt need a lymphedema physical therapist but too much to explain here. endobj Upper set (head and neck). Looking at his ankles there IS no swelling now. /Parent 2 0 R /Filter /FlateDecode https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. stream The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Tens of thousands of. Please write back in a month or so and let us know your progress. endobj First of all I cant drive, and second I have to pay a $60 copay every time I go. /Rotate 0 Lymphat Res Biol, 2016. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Breast cancer and treatment in itself was an awful journey. I had a mastectomy and 9 lymph nodes removed 3 months ago. 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. >> Flexitouch Pd32-u Lymphedema Treatment System Pump. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). They are in contact with patients who could benefit from a pneumatic pump. Its amazing to me how little doctors know about lymphedema. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use /StructParents 6 I chatted with a woman from Tacoma and another from Idaho. /GS0 37 0 R Ideas? I like to joke, Honey, time for me to put the squeeze on you Oral Oncology. The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /CropBox [0 0 612 792] where is the compassion for ill people that NEED certain healthcare to get better? I wonder if pumps can be reprogrammed. Free shipping for many products! endobj So for almost every night for the next seven years I sat down and performed MLD on my left arm. Then I got my flexitouch and my life changed. /W 0 Biomedical Optics Express. 2010; Vol. << /Im0 60 0 R 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. 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. Buying a reconditioned machine saved me some money. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. << /Font << I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. 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. 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. Try contacting different people. 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. 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. Ml6(|a\!A.;Q#[. 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. >> 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. 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. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Lymphedema Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Flexitouch Plus provides flexible program options. My thighs are so big that I can no longer Drive. endobj This is not anadvertisement for Flexitouch.). I have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. /F 4 While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. by Flexitouch. /Type /Action I really need this system and had such desperate hope. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. % Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. 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. /S /URI << /Parent 2 0 R The Flexitouch System is not used for nor intended for use to treat cellulitis. /Type /Action Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. Required fields are marked *. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 The pump is called the Flexitouch System by Tactile Medical. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Last updated March 2021. /CS /DeviceRGB 2013; Vol. << 14(4): p. 198-205, 2. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. Tens of thousands of. /TT0 23 0 R The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. /TT0 69 0 R You are benefiting the lymphedema community. 4 0 obj 14 0 obj Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. /URI (http://www.fda.gov/) My husband has a brand new system that Im trying to sell. I can relate all too well to what you have been through. The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Ridner, S.H., Dietrich, M.S., Deng, J. et al. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. >> /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) Thanks. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. 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 ] Any circumstance where increased lymphatic or venous return is undesirable /Resources << My best to you. Hi Kathi, The FaceTime call might work! https://doi.org/10.1007/s00520-020-05540-8, 3.