flexitouch plus head and neckflexitouch plus head and neck

The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. /S /URI I can relate all too well to what you have been through. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. endobj Thank you for sharing and being an advocate for lymphedema! https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) When I developed secondary lymphedema from breast cancer treatment in 2010 I asked my therapist about compression pumps. A Pilot Study to Evaluate the Feasibility and Potential Effectiveness Thanks. 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. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. 0 T Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. You are benefiting the lymphedema community. << >> I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. Keywords provided by NorthShore University HealthSystem: Why Should I Register and Submit Results? I have little confidence that the FaceTime call offered will be of much use. /Type /Page Has anyone else had any experience with this? 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. For more information, https://tactilemedical.com/about-us/. 18 0 obj Chronic Wounds Phone: 1.612.355.5100 The pump is awesome works for me iam walking better @ standing the swelling goes away!!! Developing Lymphedema and not being able to get the help that I neededwas awful. About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . When I first went to physical therapy, she was running through some more common contibuters to swelling. 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. Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. /XObject << 1 offer from $17.99 3 Pairs Lymphedema Compression Arm Sleeve 20-30 Mmhg Full Arm Support with Silicone Band Graduated Compression Arm Sleeves for Lymphedema Swelling Edema (Beige, M Size) 4 1 offer from $29.99 mediven Harmony Lymphedema Combination Compression Arm Sleeve and Gauntlet with Silicone Band 20-30 mmHg 33 167 offers from $87.98 I have been suffering from lymphedema for the past 2 years. 35 0 R] Venous Ulcers. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. endobj (Note: There are other well regarded pumps on the market. Flexitouch Plus - Treat Head & Neck Swelling At Home with This >> All reviewers. I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation. 8 0 obj Lymphat Res Biol. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. endobj Toll-free: 1.833.3TACTILE (1.833.382.2845) See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use 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. Yay! Hope it works out. The lymphedema seen in patients treated for head . News Release Details - Tactile Systems Technology, Inc. 2. 3701 Wayzata Blvd, Suite 300 Thank you for writing. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed Outcome Measures Go to Primary Outcome Measures : Symptom/Problem Improvement From Baseline to 6 Months [ Time Frame: Percent Changes between Baseline and 6 months will be assessed ] /BS << /TT1 23 0 R I always start with the one hour full arm and core setting. 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. I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump. Learn how your comment data is processed. Positive value shows an increase in pain. 1. Dr. Shelia Ridner Dr. Barbara Murphy 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. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. >> An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 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. Phone: 1.612.355.5100 Negative value shows a decrease in quality of life/overall health. Out of my sleeve, my 3/4 length sleeves arent as tight. >> You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. %PDF-1.4 >> /CS /DeviceRGB >> Positive value shows an increase in Function/Range of Motion. They are usually called something like 7 on your side or Channel 3 helps you. Toll-free: 1.833.3TACTILE (1.833.382.2845) Hi Jaime, Im hopeful that your new pump will provide relief. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. /F 4 This is not anadvertisement for Flexitouch.). Circulatory Insufficiency: What is the Difference Between Venous and Arterial Ulcers? << I know many others can as well. Thank you for sharing your husbands success with a pump. 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. endstream /TT0 69 0 R /TT1 70 0 R It seems a lot of pumps are preprogrammed for the individual. Minneapolis, MN 55416 USA Hopefully it will give me a better quality of life because I dont know what else to do at this point. (Clinical Trial). 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. I just received it yesterday and Im super hopeful that it will help. << Support Care Cancer (2020). >> << About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . /TT0 56 0 R It was a blow to the life I had that I once had. endobj My husband has a brand new system that Im trying to sell. 15 0 obj HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. /TT0 22 0 R I use it everyday for an hour. I just finished 6 weeks of radiation. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. 2. Ive had my Flexitouch for almost five months. 2008-2023 HMP Global, Inc. All rights reserved. Toll-free: 1.833.3TACTILE (1.833.382.2845) The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. 5 0 obj Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. did you sell it yet? NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). >> 7nwJ@6]?t~.} 4. stream 11 0 obj /Type /Page /C2_0 38 0 R 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. The head garment and vest for head and neck for the Flexitouch Plus system should not be used on patients who have one or more of the following conditions: Pneumatic compressor, segmental home model with calibrated gradient pressure, Chronic Venous Insufficiency Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Symptom/Problem Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Function (Range of Motion) Improvement From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Health-related Quality of Life-Overall From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Changes in Pain From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Change in Swelling From Baseline to 6 Months [TimeFrame:Percent Changes between Baseline and 6 months will be assessed], Ease of Use/Satisfaction [TimeFrame:Assessed at 6 months], A diagnosis of head and/or neck lymphedema, Must be able and willing to participate in all aspects of the registry and provide informed consent prior to registry participation. 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 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.. << /Type /Group >> Learn More Take the steps now to help your head and neck cancer survivors. >> Sort by. Hi Wandalynn . YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! Prior to using a Flexitouch, the Tacoma woman had at least two to three bouts of cellulitis a year, some requiring hospitalization. 2013; Vol. >> Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Study record managers: refer to the Data Element Definitions if submitting registration or results information. /Resources << /Filter /FlateDecode Flexitouch Pd32-u Lymphedema Treatment System Pump Since using the Flexitouch for almost a year, she had not experienced cellulitis. I have had the doctors look at my leg and rewrite a prescription for me but never try to see if my insurance will cover an air compression unit for my leg. /Type /Group HQK0)I46IC">bY3oons} K.4V./`\f0 Fs 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. Advanced pneumatic compression for treatment of lymphedema of the head They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. 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. I was rather startled at how wrapped up I was. /CropBox [0 0 612 792] I just received the flexitouch plus, but I think the leg garments are too big. << I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. /Contents [61 0 R 62 0 R 63 0 R 64 0 R 65 0 R 66 0 R 67 0 R 68 0 R] For general information, Learn About Clinical Studies. The content is not intended to substitute manufacturer instructions. /A << 1. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I?m 5? An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /StructParent 1 Subject overall health and quality of life in the past week-EORTC C30. Many, many of my patients love their pump. Please cross your fingers for me that this works. /TT2 74 0 R /URI (http://www.fda.gov/) Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational A healthy lymphatic system moves lymph fluid throughout the body. /S /Transparency stream /Parent 2 0 R /Length 412 /CS /DeviceRGB It delivers a noninvasive therapy that patients can administer themselves at home. /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 I wanted to talk to some people who had actually used the pump. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /C2_0 54 0 R I chatted with a woman from Tacoma and another from Idaho. Thanks. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. My skin appears more like the skin on my right arm. /StructParents 0 Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) H]O0+=) ES /TT2 51 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. The woman from Idaho said her arm was softer and found the machine easy to use. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. 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. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. https://doi.org/10.1007/s00520-020-05540-8, 3. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. 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. << . Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. 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! /Tabs /S How customer reviews and ratings work See All Buying Options. endobj Negative value shows a decrease in swelling. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ /CropBox [0.0 0.0 612.0 792.0] The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Keep sharing your story. Tactile Systems Technology, Inc. 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. Type of Use (Select one or both, as applicable) lXI . The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. Deng J, et al. /StructParents 7 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. I cant explain that but I can visually see a difference. Support Care Cancer (2020). Minneapolis, MN 55416 USA /Font << /Type /Page During pregnancy (applies only to the Flexitouch Plus trunk accessory). Everything in my life that I do and love and I am passionate about invloves using my hands and arms. /Contents 75 0 R /Filter /FlateDecode /Im0 24 0 R The pressure in the throat will be measured using a device called high-resolution manometry before and after wearing a treatment jacket (Flexitouch plus device). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /TT1 50 0 R /CS /DeviceRGB So for almost every night for the next seven years I sat down and performed MLD on my left arm. Hi Karyn, I will post your comment and see if Sarah still has the pump available. Except for my wrist, all my measurements showed reduction. 1. /StructParents 0 Percent change is calculated by the difference between scores averaged at 6 months versus baseline. I dont know if it will make a difference. I have been having weekly physical therapy to help with lymphedema and range of motion issues. << Support Care Cancer (2020). HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /Group << What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. My go to place when I need calming. See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 /F 4 I didnt need a lymphedema physical therapist but too much to explain here. They will reach out to Flexitouch in the process of creating a segment for the news. /StructParents 0 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. Swelling will be assessed using the ALOHA measurement protocol. K-ZB: /Subtype /Link k 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. /CropBox [0.0 0.0 612.0 792.0] This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. 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? Since using the Flexitouch for almost a year, she had not experienced cellulitis. endobj Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Flexitouch . 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 . I have skipped 1 or 2 days just 3 or 4 times since March. Actually they dont know much about lymphedema. My thighs are so big that I can no longer Drive. /Annots [10 0 R 11 0 R 12 0 R] 2144 Westlake Ave, North, Suite F Seattle, WA 98109, (206) 575-7775 [email protected]. EJVES. To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. They are programed for each individual. 2016;14(4):198205. Rz:MzI6 Karaca-Mandic P, Hirsch AT, Rockson SG, et al. where is the compassion for ill people that NEED certain healthcare to get better? 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. Flexitouch System | Dynamic Compression | Home Therapy - WoundSource 3 0 obj A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. To pump or not to pumpthat is a question that I hear in the lymphedema community. 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. Tactile Medical is a leader among clinical studies and the Flexitouch system has been studied clinically in more than 1,800 patients. /Length 470 In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts Tactile Medical Announces Enrollment of First Patient in Neck and Head Lymphedema Treatment for Cancer Survivors - Tactile Medical HTo0~G6)BjH7u /Type /Page In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. 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 My insurance paid for all of it and the Tactile rep will help you get that. 4? ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN /F 4 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. << Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. The Flexitouch Plus system provides at-home pneumatic compression therapy for daily management and symptom relief in just 32 minutes. I dont like that I have to do it but it has changed my legs back to normal. /S /Transparency Its been tough . Numerous clinical studies show achievement of major clinical benefits and cost savings /Type /Catalog Lymphat Res Biol, 2016. Percentage of each response captured. 4 0 obj {%AIqEWRA>, 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. If Im out late, I use it in the morning and then resume again in the evening. I wonder if pumps can be reprogrammed. 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^ Minneapolis, MN 55416 USA /Resources << [Patient Registry], A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema, 18 Years and older (Adult, Older Adult), West Des Moines, Iowa, United States, 50265, Asheville, North Carolina, United States, 28805, Pittsburgh, Pennsylvania, United States, 15212.
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