I was rather startled at how wrapped up I was. Our Solutions for Head and Neck - Tactile Medical I didnt make a decision to purchase a pump that day. I cannot find any shoes that fit my feet or any pants that fit comfortably . {%AIqEWRA>, >> A Registry to Evaluate the Flexitouch System and Flexitouch Plus for << Many, many of my patients love their pump. by Flexitouch. I cant explain that but I can visually see a difference. 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. Its also a relief not to manually MLD my arm every night. content.edgar-online.com 2010; Vol. >> 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^ document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. They are programed for each individual. Negative value shows a decrease in swelling. We rely on the generosity of individuals and sponsors who support our mission and activities. Ive heard from many people that they saw good results with their pump. 2008-2023 HMP Global, Inc. All rights reserved. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. Swelling will be assessed using the ALOHA measurement protocol. Lymphedema /Filter /FlateDecode /TT0 69 0 R /Type /Group 15 0 obj For more information, https://tactilemedical.com/about-us/. 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. 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? << Its brand new, used 1 time. Toll-free: 1.833.3TACTILE (1.833.382.2845) >> The warranty was the same as a new machine. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Faculty Innovators: Sheila Ridner and Barbara Murphy spearhead trials Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. >> You have reached the maximum number of saved studies (100). Looking at his ankles there IS no swelling now. Hopefully it will give me a better quality of life because I dont know what else to do at this point. 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 /Type /Page Im sorry for the experience you had with Tactile Medical. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Positive value shows an increase in quality of life/overall health. 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. I just finished 6 weeks of radiation. >> /F 4 Lymphedema Treatment in Head and Neck Cancer Patients /F 4 (Note: There are other well regarded pumps on the market. Support Care Cancer (2020). The lymphedema seen in patients treated for head . stream 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. https://doi.org/10.1007/s00520-020-. Flexitouch Plus - Tactile Medical They will reach out to Flexitouch in the process of creating a segment for the news. 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 am looking for the leg and trunk model is that what you have? /Parent 2 0 R Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 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. 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. Since using the Flexitouch for almost a year, she had not experienced cellulitis. /Contents 75 0 R https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. 14(4): p. 198-205. A healthy lymphatic system moves lymph fluid throughout the body. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] >> /W 0 Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Most significantly was the reduction in my forearm. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ >> 2. >> /Annots [10 0 R 11 0 R 12 0 R] Tactile Medical braces for new Medicare rules that will tighten access 7nwJ@6]?t~.} Yay! Ridner, S.H., Dietrich, M.S., Deng, J. et al. Flexitouch System | Dynamic Compression | Home Therapy - WoundSource 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! Ideas? endobj H]O0+=) ES << She explained that compression pumps force air into sleeves with multiple chambers. 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. /Length 585 /Im0 60 0 R << NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( Negative value shows a increase in quality of life. Its amazing how we are communicating so much more through technology because of Covid. XJ D/N500187-000-00 Rev. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. /TT2 74 0 R My husband?s pump system arrived yesterday. I only make 12k per year so its not like I can afford anything. It has made my life miserable. 10 0 obj /TT3 52 0 R My Experience with the Flexitouch Pneumatic Pump for Lymphedema. 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. HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 It has become so bad that I can barely walk. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. 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. Hi Jaime, Im hopeful that your new pump will provide relief. 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. It takes just 32 minutes per day. 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. I would contact your local news station that has a consumer investigation/help line. Support Care Cancer (2020). For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. /Tabs /S /MediaBox [0 0 612 792] The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. First of all I cant drive, and second I have to pay a $60 copay every time I go. I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . PDF Lauren Barnes - Food and Drug Administration >> I really need this system and had such desperate hope. S If Im out late, I use it in the morning and then resume again in the evening. >> Dr. Shelia Ridner Dr. Barbara Murphy doi.org/10.1007 /s00520-020-05540-8, First-ever randomized control trial of home management of head and neck lymphedema, Retrospective analysis of 205 Flexitouch user survey responses, Near-infrared fluorescence lymphatic imaging (NIRFLI) before and after Flexitouch use, Flexitouch Plus is the only FDA cleared pneumatic, See the clinical benefit of Flexitouch Plus, Longitudinal Patient Reported Outcomes Study. /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R They use them in the morning, at nightand feel very lucky.. I have it in both of my legs mostly in my thighs. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. I am looking for a left arm garment for the flexitouch plus. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. /Filter /FlateDecode It was up to me to piece it together. Rz:MzI6 /Rotate 0 As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Write a review. 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. Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Pain will be assessed using the VAS Pain Scale. History of the Northwest Lymphedema Center. 1. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. Overview Product Features Details Benefits Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. 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. 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/. /F 4 /Rotate 0 My thighs are so big that I can no longer Drive. /S /Transparency 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. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use 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. Hi Kristie, Thank you for sharing your story. /Rect [40.95 36 85.101 45.216] x >> << endobj Please remove one or more studies before adding more. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. I wanted to talk to some people who had actually used the pump. I always start with the one hour full arm and core setting. The one I bought from Amazon for $100 has more pressure, Does anyone know if the trunk is to run its cycle before the legs start, The flexi touch plus is a high priced machine to have that youre not able to use. Flexitouch . /ProcSet [/PDF /Text /ImageC] Flexitouch Plus - Treat Head & Neck Swelling At Home with This They only measured the circumference of my thighs and calfskin, not the length, so now I am STUCK with a non-refundable almost 9K system that is too long for me. /TT1 70 0 R Ive had my Flexitouch for almost five months. /Type /Action /MediaBox [0.0 0.0 612.0 792.0] Numerous clinical studies show achievement of major clinical benefits and cost savings While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. << Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Biomedical Optics Express. Last updated March 2021. Both Ease of Use/Satisfaction will be assessed by survey. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 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 head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. did you sell it yet? Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. ? Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. Hi Wandalynn . I have a uniboot compressions on both of my calves. Lymphat Res Biol. /Type /Page /Length 412 The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Daily storage of Flextouch system - Lymphedema - Inspire Phone: 1.612.355.5100 /TT0 49 0 R Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts 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. They are in contact with patients who could benefit from a pneumatic pump. Support Care Cancer (, 2020). /Resources << /CropBox [0 0 612 792] Rockson floated to my ears. It was a blow to the life I had that I once had. /MediaBox [0.0 0.0 612.0 792.0] 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. Of the patients who tried the device, 88% saw a reduction in head and neck swelling after an initial 32-minute at-home treatment with the Flexitouch system, and 89% of patients reported. 35 0 R] 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. endobj It takes just 32 minutes per day. 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). Adams, KE, Rasmussen JC, Darne C, et al. /Font << /Count 7 Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment << stream Tactile Systems debuts Flexitouch head and neck lymphedema treatment /Resources << Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. % >> Heart failure (acute pulmonary edema, decompensated acute heart failure) A Pilot Study to Evaluate the Feasibility and Potential Effectiveness /Resources << Toll-free: 1.833.3TACTILE (1.833.382.2845) /Type /Action Please remove one or more studies before adding more. << %PDF-1.4 Try contacting different people. I dont know if it will make a difference. They are usually called something like 7 on your side or Channel 3 helps you. endobj 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. UGH! In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Can I use the machine on lower limbs with compression garments above? 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 . /TT3 59 0 R 7 0 obj /StructParents 2 /Tabs /S 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. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. >> >> Faced with negative publicity, they often end up making things right. Tactile Medical Announces Enrollment of First Patient in - Yahoo! Then I got my flexitouch and my life changed. /ExtGState << Why Should I Register and Submit Results? One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Buying a reconditioned machine saved me some money. 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. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 11 0 obj We were asked to improve the ease of donning . Last updated March 2021. 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. My Experience with the Flexitouch Pneumatic Pump for Lymphedema Im a pianist and its become my safe place. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. /C2_0 21 0 R This is a long story but I have managed it as best as I can but when I finally was ready to prove to my insurance that the Flexitouch was needed the insurance denied me coverage. >> What really gripes me is that my nurse practitioner wouldnt even consider ordering one. endobj An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 1 0 obj endobj 1. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Breast cancer and treatment in itself was an awful journey. Thank you for sharing and being an advocate for lymphedema! I use it every evening. >> Search. 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. Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /TT1 50 0 R >> Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. I have little confidence that the FaceTime call offered will be of much use. 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! /Subtype /Link << /C2_1 55 0 R 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. Flexitouch Plus Lymphedema Treatment of the Head and Neck /Group << 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. 2016;14(4):198205. I didnt need a lymphedema physical therapist but too much to explain here. >> HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. 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. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). When I first went to physical therapy, she was running through some more common contibuters to swelling. (6Kjw_XGz'g &p An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 2015 51 (431-437), 1. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. I use it everyday for an hour. 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 decided to purchase one without insurance. Keep in touch! 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. Its been tough . I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch.
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