flexitouch plus head and neckflexitouch plus head and neck

It takes just 32 minutes per day. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Its New, Your email address will not be published. Lymphat Res Biol, 2016. >> Im only 44 years old , and I have kids that need mom back. /Resources << The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Listing a study does not mean it has been evaluated by the U.S. Federal Government. << Positive value shows an increase in pain. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. >> Ive had my Flexitouch for almost five months. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. /TT2 74 0 R did you sell it yet? /Resources << 4 0 obj /S /Transparency One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. endobj 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. /S /Transparency Yes, taking care of ones body requires several interventions. Ive heard from many people that they saw good results with their pump. >> {%AIqEWRA>, I like to joke, Honey, time for me to put the squeeze on you /Rect [90.257 252.64 421.33 266.44] 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. I chatted with a woman from Tacoma and another from Idaho. /Filter /FlateDecode If anyone has one, or knows of one, please contact me. When I first went to physical therapy, she was running through some more common contibuters to swelling. >> 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. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. % /Parent 2 0 R Do you know of anyone whom would want to buy it? 5. Lymphat Res Biol. 35 0 R] 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. 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. I really need this system and had such desperate hope. >> /BS << I did send them an email and asked them to look at your case again. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. The lymphedema seen in patients treated for head . I have a uniboot compressions on both of my calves. /TT3 72 0 R 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. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. /StructParents 0 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^ I cant explain that but I can visually see a difference. /Rotate 0 Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Contents 53 0 R Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. The warranty was the same as a new machine. 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. O ce they are used the government wont always them to use them on another. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Has anyone else had any experience with this? Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 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. 1 0 obj I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Negative value shows a decrease in quality of life/overall health. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. 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. . Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Type of Use (Select one or both, as applicable) lXI . You are benefiting the lymphedema community. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) Material and methods Design and participants Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /Group << /Length 585 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/. 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. Another set of pads enveloped my left thigh and trunk. >> Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. /S /URI The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. 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 What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Filter by. /TT1 70 0 R Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. https://doi.org/10.1007/s00520-020-. >> Its also a relief not to manually MLD my arm every night. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. << /Parent 2 0 R Biomedical Optics Express. Sort by. Top reviews. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I am looking for a left arm garment for the flexitouch plus. When she said piano I froze. Since using the Flexitouch for almost a year, she had not experienced cellulitis. 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) . /Type /Page It delivers a noninvasive therapy that patients can administer themselves at home. So we appealed 3 times. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. 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 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! Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. I have been having weekly physical therapy to help with lymphedema and range of motion issues. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? Hi Karyn, I will post your comment and see if Sarah still has the pump available. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. 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). 2. 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. 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. >> I had a mastectomy and 9 lymph nodes removed 3 months ago. Negative value shows a decrease in symptoms/problems. Buying a reconditioned machine saved me some money. I cannot find any shoes that fit my feet or any pants that fit comfortably . Please cross your fingers for me that this works. Im a pianist and its become my safe place. 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 As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time Hi Wally, Hope someone is able to meet your request. I always start with the one hour full arm and core setting. JAMA Dermatol. /Im0 24 0 R Just wondering if you have any ideas of whom to contact on such a thing. Minneapolis, MN 55416 USA I was told purchased high priced left garments which I dont think I needed. /Type /Group Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. /Font << Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). I wonder if pumps can be reprogrammed. Dr. Shelia Ridner Dr. Barbara Murphy What is encouraging is that you have had success with managing your lymphedema! endobj He just never could get use to using it and being able to don the garments. >> In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. 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. Faced with negative publicity, they often end up making things right. The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency 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. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Its amazing to me how little doctors know about lymphedema. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? 1(1): 114125. /Contents 73 0 R /Type /Page 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! 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. 13 0 obj /Filter /FlateDecode 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. 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. I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. << In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. /Type /Page Learn More Take the steps now to help your head and neck cancer survivors. I have a pump system left and right leg also stomach wraps. /Font << They are in contact with patients who could benefit from a pneumatic pump. >> Managing my lymphedema requires attention and an assortment of tools. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. 14(4): p. 198-205, 2. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Toll-free: 1.833.3TACTILE (1.833.382.2845) What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) 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. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Toll-free: 1.833.3TACTILE (1.833.382.2845) 1. Its something Im passionate about. Surprisingly, my therapists measurements showed minimal difference with previous measurements. The woman from Idaho said her arm was softer and found the machine easy to use. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. 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.
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