flexitouch plus head and neck

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 delivers a noninvasive therapy that patients can administer themselves at home. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. Lymphedema - Head and Neck Cancer Alliance To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Faculty Innovators: Sheila Ridner and Barbara Murphy spearhead trials She explained that compression pumps force air into sleeves with multiple chambers. /Filter /FlateDecode 18 0 obj My insurance paid for all of it and the Tactile rep will help you get that. 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. << The study, published in October 2015 and authored by Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN, showed promising results when a patient used the Flexitouch System for one year. XJ Numerous garment and program options to meet each patient's unique treatment needs /Font << /Group << /Font << During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Lymphedema /Tabs /S Minneapolis, MN 55416 USA tm233510-5_424b5 - none - 7.6719207s I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. /Pages 2 0 R 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. >> >> Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) /CropBox [0 0 612 792] /Version /1.4 This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Adams, KE, Rasmussen JC, Darne C, et al. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. When she said piano I froze. (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. 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. . Top reviews. 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. by Flexitouch. Tactile Systems Technology, Inc. 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. /XObject << Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ I have been having weekly physical therapy to help with lymphedema and range of motion issues. /S /Transparency 2010; Vol. Positive value shows an increase in quality of life/overall health. 17 0 obj /TT3 59 0 R Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /CropBox [0.0 0.0 612.0 792.0] << (Clinical Trial). For general information, Learn About Clinical Studies. In June 2017, we announced that we received 510(k) clearance from the FDA for the Flexitouch Plus, the third-generation version of our Flexitouch system. 6 0 obj Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. /StructParents 2 He just never could get use to using it and being able to don the garments. /Im0 24 0 R Looking at his ankles there IS no swelling now. Hi Wandalynn . >> 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. /C2_0 48 0 R Study record managers: refer to the Data Element Definitions if submitting registration or results information. I can relate all too well to what you have been through. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. /C2_0 38 0 R Just wondering if you have any ideas of whom to contact on such a thing. Choosing to participate in a study is an important personal decision. I dont like that I have to do it but it has changed my legs back to normal. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. >> Tactile Medical braces for new Medicare rules that will tighten access 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. I wish you success! /TT0 22 0 R >> Negative value shows a increase in quality of life. 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. /Rotate 0 /A << Our Solutions for Head and Neck - Tactile Medical I am looking for the leg and trunk model is that what you have? << /Rect [90.257 252.64 421.33 266.44] Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 7 0 obj /S /URI I was told purchased high priced left garments which I dont think I needed. 3. NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( Lymphat Res Biol. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Rockson floated to my ears. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /Annots [39 0 R] << I use it everyday for an hour. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Overview Product Features Details Benefits If anyone has one, or knows of one, please contact me. stream Talk with your doctor and family members or friends about deciding to join a study. 3701 Wayzata Blvd, Suite 300 Pembrolizumab plus cetuximab in patients with recurrent . /Length 680 /Length 412 1. It delivers a noninvasive therapy that patients can administer themselves at home. endobj The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Rect [40.95 36 85.101 45.216] 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 had a mastectomy and 9 lymph nodes removed 3 months ago. Talk with your doctor and family members or friends about deciding to join a study. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. Then I got my flexitouch and my life changed. 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! D/N500187-000-00 Rev. Advanced Techniques in Canine and Feline Neurosurgery Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? Negative value shows a decrease in symptoms/problems. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. %PDF-1.4 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. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 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. /TT3 72 0 R 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? 9 0 obj 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.. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Developing Lymphedema and not being able to get the help that I neededwas awful. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. /S /Transparency /TT0 69 0 R ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Another set of pads enveloped my left thigh and trunk. Im a pianist and its become my safe place. 8 0 obj What really gripes me is that my nurse practitioner wouldnt even consider ordering one. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. /Type /Group Information provided by (Responsible Party): The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. Please write back in a month or so and let us know your progress. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. Support Care Cancer (2020). Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. In head and neck cancer, lymphedema can be caused by: Surgery: When lymph nodes and vessels are removed during surgery for cancer, it becomes harder for the body to move lymph fluid out of the area. 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. Last updated March 2021. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. << She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time [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. /Resources << /Filter /FlateDecode /TT2 58 0 R endstream Positive value shows an increase in symptoms/problems. Any circumstance where increased lymphatic or venous return is undesirable I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /TT2 51 0 R The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 << For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Breast cancer and treatment in itself was an awful journey. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs I just received it yesterday and Im super hopeful that it will help. What is encouraging is that you have had success with managing your lymphedema! Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). It has become so bad that I can barely walk. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /F 4 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. I wanted to talk to some people who had actually used the pump. /ProcSet [/PDF /Text /ImageC] The pump has helped you achieve significant results. It takes just 32 minutes per day. The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. content.edgar-online.com /StructParents 8 It seems a lot of pumps are preprogrammed for the individual. ? Study record managers: refer to the Data Element Definitions if submitting registration or results information. It was up to me to piece it together. 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. 2016;14(4):198205. /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 A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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. /CropBox [0.0 0.0 612.0 792.0] /Filter /FlateDecode 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 ] In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. << It was a blow to the life I had that I once had. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 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. /TT1 23 0 R 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. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. 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. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. My interest in pumps suddenly skyrocketed! /Filter /FlateDecode Tactile Systems debuts Flexitouch head and neck lymphedema treatment I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. 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. << /C2_0 54 0 R Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. 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. /CropBox [0.0 0.0 612.0 792.0] Upper set (head and neck). 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 Please remove one or more studies before adding more. . The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Search. /A << Support Care Cancer (2020). Negative value shows a decrease in quality of life/overall health. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /ExtGState << I have skipped 1 or 2 days just 3 or 4 times since March. Biomedical Optics Express. 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. 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 . endobj 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. Thanks. /Parent 2 0 R /F 4 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://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. My go to place when I need calming. /W 0 The leg garments that I received are for a much taller person. endobj Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). Deng J, et al. /Group << Its amazing how we are communicating so much more through technology because of Covid. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. My best to you. Ive had my Flexitouch for almost five months. Phone: 1.612.355.5100 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. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 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. >> Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. /Tabs /S Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. Try contacting different people. Pain will be assessed using the VAS Pain Scale. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. This is not anadvertisement for Flexitouch.). 35 0 R] They are in contact with patients who could benefit from a pneumatic pump. Both Ease of Use/Satisfaction will be assessed by survey. Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Required fields are marked *. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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) My husband has a brand new system that Im trying to sell. Flexitouch System | Dynamic Compression | Home Therapy - WoundSource Flexitouch Plus - Applying the Head and Neck Garment Set Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 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. 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 has made my life miserable. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. 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. /W 0 /GS0 37 0 R /Type /Group Venous Ulcers. Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. endstream Swelling will be assessed using the ALOHA measurement protocol. /Group << Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /CropBox [0 0 612 792] PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and /ProcSet [/PDF /Text] Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical Flexitouch Plus provides flexible program options. 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. >> Negative value shows a decrease in Function/Range of Motion. /BS << Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. 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.