>> /Im0 24 0 R Support Care Cancer (2020). /CropBox [0.0 0.0 612.0 792.0] stream History of the Northwest Lymphedema Center. 2. Along with testing his blood sugar, taking his meds, and a sensible diet/exercise part of a complete diabetes maintenance routine? /CropBox [0 0 612 792] Most significantly was the reduction in my forearm. Thank you for sharing your husbands success with a pump. Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. Support Care Cancer (, 2020). Both Ease of Use/Satisfaction will be assessed by survey. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Minneapolis, MN 55416 USA The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Support Care Cancer (2020). >> /Font << A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Since using the Flexitouch for almost a year, she had not experienced cellulitis. Its my new normal and Im thankful!! My therapist said they cannot be reused by another. 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. 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? She explained that compression pumps force air into sleeves with multiple chambers. 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. First of all I cant drive, and second I have to pay a $60 copay every time I go. Muluk SC, Hirsch AT, Tafe EC. >> /ProcSet [/PDF /Text /ImageC] /TT0 69 0 R Positive value shows an increase in Function/Range of Motion. 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. Rz:MzI6 I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /TT1 70 0 R Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. /BS << All subjects will receive a single intervention. FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. >> Positive value shows an increase in pain. Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment Lymphedema /Type /Page Tens of thousands of. << 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! /Type /Group Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. by Flexitouch. Tactile Systems Technology, Inc. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /TT0 49 0 R You have reached the maximum number of saved studies (100). /StructParents 6 It delivers a noninvasive therapy that patients can administer themselves at home. Venous Ulcers. You have reached the maximum number of saved studies (100). Support Care Cancer (2020). H]O0+=) ES 13 0 obj >> 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. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. >> /TT3 72 0 R endobj I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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. /Im0 60 0 R >> 10 0 obj Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. >> No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /CS /DeviceRGB 18 0 obj endstream A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. >> Last updated March 2021. /Filter /FlateDecode /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] The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /BS << She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. 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. /Group << 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. /Font << 16 0 obj Rockson floated to my ears. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Phone: 1.612.355.5100 /Font << As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. /Resources << They will reach out to Flexitouch in the process of creating a segment for the news. Call us at 1.833.3TACTILE (1-833-382-2845), 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. I dont know if it will make a difference. My insurance paid for all of it and the Tactile rep will help you get that. What is encouraging is that you have had success with managing your lymphedema! The pump is awesome works for me iam walking better @ standing the swelling goes away!!! 2016;14(4):198205. 2008-2023 HMP Global, Inc. All rights reserved. I knew Dr. Stanley Rockson of Stanford University was performing a drug trial with a medication called Uberimex for the treatment of lymphedema so I was keenly interested in learning what he said about this new pump. 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. stream The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Hope it works out. Its New, Your email address will not be published. Another set of pads enveloped my left thigh and trunk. I had a mastectomy and 9 lymph nodes removed 3 months ago. Tactile Systems Technology (TCMD +0.6%) announces the enrollment of the first patient in a randomized, controlled trial evaluating the effectiveness of its Flexitouch Plus system for the treatment . A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. << Hi Kristie, Thank you for sharing your story. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /Tabs /S 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. O ce they are used the government wont always them to use them on another. 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. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Upper set (head and neck). The head & neck of non-human animals - | Cambridge SMART Vocabulary The leg garments that I received are for a much taller person. Please remove one or more studies before adding more. It delivers a noninvasive therapy that patients can administer themselves at home. endobj 4. Toll-free: 1.833.3TACTILE (1.833.382.2845) The lymphedema seen in patients treated for head . Faced with negative publicity, they often end up making things right. >> I know many others can as well. 6 0 obj /CS /DeviceRGB /Subtype /Link 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. Filter by. I did send them an email and asked them to look at your case again. The Flexitouch System is not used for nor intended for use to treat cellulitis. Except for my wrist, all my measurements showed reduction. /Parent 2 0 R D/N500187-000-00 Rev. ? Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds or gangrene) Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. endobj The warranty was the same as a new machine. The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Dr. Shelia Ridner Dr. Barbara Murphy /Length 412 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). >> 5 0 obj View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, 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. Overview Product Features Details Benefits 0 T /TT0 69 0 R Karaca-Mandic P, Hirsch AT, Rockson SG, et al. eIb? /Rotate 0 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. This is not anadvertisement for Flexitouch.). To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. /Rotate 0 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. (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. /MediaBox [0.0 0.0 612.0 792.0] Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). /Tabs /S /Resources << Its brand new, used 1 time. >> For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. >> EJVES. It takes just 32 minutes per day. >> I decided to purchase one without insurance. (Clinical Trial). 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. (6Kjw_XGz'g &p >> 3701 Wayzata Blvd, Suite 300 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 thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. /Rect [90.257 252.64 421.33 266.44] The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. /TT1 70 0 R Has anyone else had any experience with this? /Contents 36 0 R Many head and neck cancer survivors are faced with an additional challenge: lymphedema. /Type /Group stream It delivers a noninvasive therapy that patients can administer themselves at home. >> 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. I cannot find any shoes that fit my feet or any pants that fit comfortably . 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 Muluk SC, Hirsch AT, Tafe EC. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. /Font << I only make 12k per year so its not like I can afford anything. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 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. Thanks. We rely on the generosity of individuals and sponsors who support our mission and activities. Ml6(|a\!A.;Q#[. /ExtGState << stream 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. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. endobj Chronic Wounds >> endobj /Tabs /S /Subtype /Link Hi Wandalynn . Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 4? All reviewers. 1. 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. << Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. The pump is called the Flexitouch System by Tactile Medical. Subject overall health and quality of life in the past week-EORTC C30. I wonder if pumps can be reprogrammed. /W 0 15 0 obj 4 0 obj /StructParents 0 The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. I use it every evening. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. /C2_1 55 0 R Thumbs up for Flexi-Touch!! Many, many of my patients love their pump. 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 Positive value shows an increase in quality of life/overall health. I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. 1. /S /Transparency Managing my lymphedema requires attention and an assortment of tools. Negative value shows a increase in quality of life. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. Buying a reconditioned machine saved me some money. 2016;14(4):198205. 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. Looking at his ankles there IS no swelling now. 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 study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. /TT0 22 0 R >> Adams, KE, Rasmussen JC, Darne C, et al. /Tabs /S Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. Phone: 1.612.355.5100 endobj /CropBox [0 0 612 792] 2. 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. /Resources << Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. 5. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Yes, taking care of ones body requires several interventions. 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. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. 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. 8 0 obj << /Filter /FlateDecode /Type /Page I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. endobj 2013; Vol. Explain the situation to them. Surprisingly, my therapists measurements showed minimal difference with previous measurements. /CropBox [0.0 0.0 612.0 792.0] In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP My thighs are so big that I can no longer Drive. For general information, Learn About Clinical Studies.
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