Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Negative value shows a decrease in symptoms/problems. 7nwJ@6]?t~.} I wonder if pumps can be reprogrammed. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. /Contents 53 0 R This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. It delivers a noninvasive therapy that patients can administer themselves at home. /Font << /TT1 23 0 R All subjects will receive a single intervention. endobj /F 4 Ridner, S.H., Dietrich, M.S., Deng, J. et al. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /Type /Pages /TT0 69 0 R /CropBox [0 0 612 792] /Type /Page Free shipping for many products! 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. /Type /Page Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. Negative value shows a decrease in pain. I would contact your local news station that has a consumer investigation/help line. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. 2016;14(4):198205. Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? Toll-free: 1.833.3TACTILE (1.833.382.2845) 5 0 obj >> 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. Lymphedema Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational /Type /Page >> >> Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. I had to use theyre cheaper system for one month before my insurance would pay for the flexitouch. /StructParents 7 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. https://www.tactilemedical.com/wp-content//uploads/2018/03/500266-002-RevC-JAMA-Clinical-Highlight.pdf. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 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. Phone: 1.612.355.5100 >> 5. /Parent 2 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. I always start with the one hour full arm and core setting. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. Thank you for sharing and being an advocate for lymphedema! As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. /XObject << A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. 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. The head & neck of non-human animals - | Cambridge SMART Vocabulary Hi Karyn, I will post your comment and see if Sarah still has the pump available. YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! 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 I just received the flexitouch plus, but I think the leg garments are too big. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. I wish you success! Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Why Should I Register and Submit Results? document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. << We were asked to improve the ease of donning . /Subtype /Link /BS << Many, many of my patients love their pump. endobj I would suggest you keep contacting Tactile Medical. >> I will always have Lymphedema but the Flexitouch Plus was the last peice of the puzzle that I needed and I am so thankful and emotionally grateful that I am able to have it. When she said piano I froze. Except for my wrist, all my measurements showed reduction. /S /URI In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. Please write back in a month or so and let us know your progress. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Positive value shows an increase in symptoms/problems. /Pages 2 0 R 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. The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. 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. 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? endobj Write a review. The woman from Idaho said her arm was softer and found the machine easy to use. /TT2 71 0 R stream x Actually they dont know much about lymphedema. . It was a blow to the life I had that I once had. Positive value shows an increase in swelling. /Resources << /TT1 50 0 R 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) . O ce they are used the government wont always them to use them on another. Toll-free: 1.833.3TACTILE (1.833.382.2845) Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Out of my sleeve, my 3/4 length sleeves arent as tight. /Resources << I really need this system and had such desperate hope. where is the compassion for ill people that NEED certain healthcare to get better? Since my trouble spot is below my elbow, several times a week I use the 22 minute forearm and hand setting. Subject Quality of Life will be assessed using EORTC C30 questionnaire. << /Rotate 0 Top reviews. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. Negative value shows a increase in quality of life. Positive value shows an decrease in quality of life. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. I have lymphedema in my right arm, breast and axilla. Toll-free: 1.833.3TACTILE (1.833.382.2845) Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . >> /MediaBox [0 0 612 792] 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. >> Im sorry for the experience you had with Tactile Medical. << Overview Product Features Details Benefits >> Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? 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 . Surprisingly, my therapists measurements showed minimal difference with previous measurements. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. The whole process, though limiting my ambulation, was comfortable and relaxing. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. My therapist said they cannot be reused by another. 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/. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. Negative value shows a decrease 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. stream Support Care Cancer (, 2020). (Clinical Trial). /StructParents 6 >> 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. stream /ExtGState << Positive value shows an increase in pain. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. 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. Required fields are marked *. They will reach out to Flexitouch in the process of creating a segment for the news. /Subtype /Link Michelin Man came to mind as I stretched out on the couch. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. 13 0 obj In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. I have been suffering from lymphedema for the past 2 years. 4. I was rather startled at how wrapped up I was. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. It delivers a noninvasive therapy that patients can administer themselves at home. Its New, Your email address will not be published. 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. /TT2 74 0 R 12 0 obj 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. 2 0 obj Do you know of anyone whom would want to buy it? Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. /TT0 49 0 R Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). /CropBox [0 0 612 792] The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. /Length 680 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). >> I like to joke, Honey, time for me to put the squeeze on you 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. /Version /1.4 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. How customer reviews and ratings work See All Buying Options. I need help but theres a no return policy. This is not anadvertisement for Flexitouch.). /Subtype /Link I dont know if it will make a difference. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. Faced with negative publicity, they often end up making things right. /S /Transparency Filter by. Its my new normal and Im thankful!! I dont like that I have to do it but it has changed my legs back to normal. Support Care Cancer (2020). /Length 412 >> /Tabs /S I used it a few times and Im good now. I am looking for the leg and trunk model is that what you have? >> Most significantly was the reduction in my forearm. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. /Type /Page Both Ease of Use/Satisfaction will be assessed by survey. Words like new kind of pump, different than the old types, favorable studies, and Dr. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I have little confidence that the FaceTime call offered will be of much use. Lymphat Res Biol. 2015 51 (431-437), 1. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. 16 0 obj Thank you for writing. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. Sort by. 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) endobj XJ September 30, 2021 09:03 ET I have a co/ pay of $422.57 yet to pay, But not until they get it so it can be used I kind of wish I had never got it. /TT1 57 0 R Refer to the Legal Notice for express terms of use. /TT0 69 0 R For more information, https://tactilemedical.com/about-us/. Its been tough . /Rect [90.257 252.64 421.33 266.44] Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Support Care Cancer (2020). I decided to purchase one without insurance. endobj This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. History of the Northwest Lymphedema Center. ? /Resources << Yes, taking care of ones body requires several interventions. /A << Lymphat Res Biol, 2016. /Filter /FlateDecode /Type /Group Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /Contents 36 0 R 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. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. It was up to me to piece it together. << Your email address will not be published. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. /Tabs /S Hi Kristie, Thank you for sharing your story. /ProcSet [/PDF /Text] Adams, KE, Rasmussen JC, Darne C, et al. 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. 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. 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^ 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. All reviewers. It takes just 32 minutes per day. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. 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. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. To pump or not to pumpthat is a question that I hear in the lymphedema community. >> endobj Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) 2010; Vol. stream /URI (http://www.fda.gov/) /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] Percent change is calculated by the difference between scores averaged at 6 months versus baseline. First of all I cant drive, and second I have to pay a $60 copay every time I go. endobj endobj /URI (http://www.fda.gov/) The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. /Type /Action /CropBox [0.0 0.0 612.0 792.0] So we appealed 3 times. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Search. 14(4): p. 198-205, 2. Please remove one or more studies before adding more. /Parent 2 0 R >> One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /StructParent 1 Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. /Filter /FlateDecode Positive value shows an increase in quality of life/overall health. 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.