flexitouch plus head and neck

Adams, KE, Rasmussen JC, Darne C, et al. Sort by. Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. >> /Rotate 0 << Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) 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 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. /Parent 2 0 R Numerous clinical studies show achievement of major clinical benefits and cost savings Required fields are marked *. /MediaBox [0 0 612 792] Overview Product Features Details Benefits /Parent 2 0 R This is not anadvertisement for Flexitouch.). I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. Hi Karyn, I will post your comment and see if Sarah still has the pump available. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Looking at his ankles there IS no swelling now. 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. I had a mastectomy and 9 lymph nodes removed 3 months ago. /Filter /FlateDecode Please write back in a month or so and let us know your progress. For general information, Learn About Clinical Studies. It delivers a noninvasive therapy that patients can administer themselves at home. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /A << Many head and neck cancer survivors are faced with an additional challenge: lymphedema. Type of Use (Select one or both, as applicable) lXI . I have one new for sale. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. /TT2 51 0 R K-ZB: /Tabs /S 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. /W 0 The trials primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. The Flexitouch Plus system should not be used on patients with one or more of the following conditions: (Note: There are other well regarded pumps on the market. /Tabs /S Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. /BS << Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. 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. >> endobj When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. >> HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. 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. 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. I have been suffering from lymphedema for the past 2 years. /Length 680 }3eIH]^p~>_ y#h`*#OPQB_lVI"p! Your email address will not be published. Venous Ulcers. September 30, 2021 09:03 ET I didnt need a lymphedema physical therapist but too much to explain here. Negative value shows a decrease in pain. The woman from Idaho said her arm was softer and found the machine easy to use. /Subtype /Link I was rather startled at how wrapped up I was. >> Swelling will be assessed using the ALOHA measurement protocol. /CropBox [0 0 612 792] I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. /Length 585 HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 10 0 obj >> 3. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. Buying a reconditioned machine saved me some money. 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. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. So for almost every night for the next seven years I sat down and performed MLD on my left arm. /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] Tactile Systems Technology, Inc. MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. >> >> Keep sharing your story. /StructParents 0 Learn how your comment data is processed. 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. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Many, many of my patients love their pump. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. 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. How customer reviews and ratings work See All Buying Options. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time | Source: 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. 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. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. My husband has a brand new system that Im trying to sell. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational /MediaBox [0.0 0.0 612.0 792.0] /CS /DeviceRGB >> Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I like to joke, Honey, time for me to put the squeeze on you 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. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? /CropBox [0.0 0.0 612.0 792.0] Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. For more information, https://tactilemedical.com/about-us/. The Flexitouch System is not used for nor intended for use to treat cellulitis. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Its been tough . 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) trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. I can relate all too well to what you have been through. 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. 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! 12 0 obj << 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. Out of my sleeve, my 3/4 length sleeves arent as tight. /StructParents 7 Thanks. Chronic Wounds Search. 2016;14(4):198205. /XObject << 8 0 obj Phone: 1.612.355.5100 Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Internal lymphedema measurement [TimeFrame:2 hours], External lymphedema measurement [TimeFrame:2 hours], Patients with tumors of the nasopharynx, oral cavity, oropharynx, hypopharynx, or larynx who will have radiation therapy as part of their treatment plan, Significant surgical resection of pharyngeal constrictor muscles, Patients with persistent or recurrent disease, Patients who have contraindications to use Flexitouch Plus device. The pump is called the Flexitouch System by Tactile Medical. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Im sorry for the experience you had with Tactile Medical. << About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . It delivers a noninvasive therapy that patients can administer themselves at home. 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. 11 0 obj https://doi.org/10.1007/s00520-020-05540-8, 3. >> >> /Contents 53 0 R endobj 2. endstream << Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. The lymphedema seen in patients treated for head . 3 0 obj For general information, Learn About Clinical Studies. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. All subjects will receive a single intervention. 16 0 obj YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Actually they dont know much about lymphedema. 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. Hi Wally, Hope someone is able to meet your request. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. Lymphat Res Biol, 2016. Lymphat Res Biol. /MediaBox [0.0 0.0 612.0 792.0] between head and neck cancer and lymphedema. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. >> 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. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. 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. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. 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. /ProcSet [/PDF /Text] 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. To pump or not to pumpthat is a question that I hear in the lymphedema community. /TT1 57 0 R Most significantly was the reduction in my forearm. Pain will be assessed using the VAS Pain Scale. (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. << My lymphedema therapist also told me that the pumps werent worth it. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 4. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Talk with your doctor and family members or friends about deciding to join a study. Free shipping for many products! /Font << . The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Positive value shows an increase in symptoms/problems. 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. They are programed for each individual. 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. >> Faced with negative publicity, they often end up making things right. endobj Study record managers: refer to the Data Element Definitions if submitting registration or results information. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. I decided to purchase one without insurance. XJ Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. 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. /F 4 They use them in the morning, at nightand feel very lucky.. >> I wanted to talk to some people who had actually used the pump. We were asked to improve the ease of donning . Tens of thousands of. 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^ << >> /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 {%AIqEWRA>, 2013; Vol. /Subtype /Link . >> I have little confidence that the FaceTime call offered will be of much use. >> Support Care Cancer (2020). Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. >> /F 4 /TT3 59 0 R Learn More Take the steps now to help your head and neck cancer survivors. Except for my wrist, all my measurements showed reduction. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. Has anyone else had any experience with this? Please cross your fingers for me that this works. /Pages 2 0 R The whole process, though limiting my ambulation, was comfortable and relaxing. The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. /Type /Page 15 0 obj I use it everyday for an hour. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. >> The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. During pregnancy (applies only to the Flexitouch Plus trunk accessory). k The Flexitouch Plus system and garments for legs, arms, trunk and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions, such as lymphedema, primary lymphedema, post-mastectomy edema, phlebolymphedema, lipedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiency, reducing wound healing time, treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. My skin appears more like the skin on my right arm. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /TT1 50 0 R PW!\v(jfz:yX 8$W"wqHbxQDL The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. /XObject << endobj He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. 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. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /TT0 69 0 R Both Ease of Use/Satisfaction will be assessed by survey. 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). 14(4): p. 198-205. /TT3 52 0 R Im only 44 years old , and I have kids that need mom back. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. Evaluation of External Lymphedema Treatment on Pharyngeal Pressure in Head and Neck Cancer Patients, 18 Years to 100 Years (Adult, Older Adult). endobj /URI (http://www.fda.gov/) Material and methods Design and participants & weigh 126 lbs. Upper set (head and neck). 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. /Type /Group 2016;14(4):198205. /Count 7 /W 0 It has made my life miserable. It has become so bad that I can barely walk. I greatly encourage others to try to obtain one if they are able and if it is a good option for them. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. Hi Deborah, How wonderful you have had such positive success with your pump. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. stream /A << 0 T Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). 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. Support Care Cancer (, 2020). 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? /Font << 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. % /W 0 Minneapolis, MN 55416 USA 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. >> While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. Please remove one or more studies before adding more. /Type /Page /TT3 74 0 R No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. Support Care Cancer (2020). 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 One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. /MediaBox [0.0 0.0 612.0 792.0] Surprisingly, my therapists measurements showed minimal difference with previous measurements. Rockson floated to my ears. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Tens of thousands of. I just received it yesterday and Im super hopeful that it will help.

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