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. /Contents [40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R] For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. 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 Ive heard from many people that they saw good results with their pump. >> Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 15 0 obj FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. Rockson floated to my ears. 6 0 obj Percentage of each response captured. >> D/N500187-000-00 Rev. /Type /Page /A << The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. Lymphat Res Biol, 2016. 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! Yes. 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. /CS /DeviceRGB About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . 4 0 obj /TT3 52 0 R /A << /F 4 A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Rz:MzI6 I have little confidence that the FaceTime call offered will be of much use. << 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 . 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 ] 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. /TT2 71 0 R Required fields are marked *. Venous Ulcers. /F 4 Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Group << https://doi.org/10.1007/s00520-020-05540-8, Flexitouch Pneumatic Compression Device and Self-management of lymphedema. 1(1): 114125. 7 0 obj endobj endstream Its New, Your email address will not be published. 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. /Type /Group I wish you success! 13 0 obj I dont like that I have to do it but it has changed my legs back to normal. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. /C2_0 54 0 R What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. Neck circumference measurement will be done using standard tape measure before and after wearing a treatment jacket (Flexitouch plus device). It has made my life miserable. Top reviews. Hi Wally, Hope someone is able to meet your request. 5. Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! O ce they are used the government wont always them to use them on another. Listing a study does not mean it has been evaluated by the U.S. Federal Government. /CropBox [0 0 612 792] >> /Im0 24 0 R << The woman from Idaho said her arm was softer and found the machine easy to use. I didnt need a lymphedema physical therapist but too much to explain here. /Type /Group Hi Karyn, I will post your comment and see if Sarah still has the pump available. Deborah, hello, my name is Peggy and I also have lymphedema in my left leg. /Tabs /S 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. /StructParents 7 I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. First of all I cant drive, and second I have to pay a $60 copay every time I go. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /Count 7 << 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/. During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. 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. >> For general information, Learn About Clinical Studies. Sort by. Thumbs up for Flexi-Touch!! The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. endobj 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. Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. /F 4 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. /MediaBox [0.0 0.0 612.0 792.0] >> Im sorry for the experience you had with Tactile Medical. Minneapolis, MN 55416 USA All subjects will receive a single intervention. 10 0 obj Explain the situation to them. Positive value shows an increase in quality of life/overall health. Swelling will be assessed using the ALOHA measurement protocol. Listing a study does not mean it has been evaluated by the U.S. Federal Government. /Filter /FlateDecode Since using the Flexitouch for almost a year, she had not experienced cellulitis. /Rotate 0 /MediaBox [0 0 612 792] 2016;14(4):198205. I have been having weekly physical therapy to help with lymphedema and range of motion issues. endobj /Rotate 0 endobj /BS << /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 /Filter /FlateDecode One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. I know many others can as well. /TT0 56 0 R HTn0+xIt XLRIiE)k!SS14U E __Z2om[]n&x*nAa(0A\0 /Parent 2 0 R 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. Positive value shows an increase in pain. They are programed for each individual. When she said piano I froze. It takes just 32 minutes per day. 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. We were asked to improve the ease of donning . endobj Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. between head and neck cancer and lymphedema. Choosing to participate in a study is an important personal decision. /TT0 49 0 R /StructParents 8 Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. << /Type /Action Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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). << So we appealed 3 times. 3701 Wayzata Blvd, Suite 300 I feel like my physical therapist or the sales rep from Tactile Medical should have caught this BEFORE I was encouraged to order an expensive machine that I may or may not be able to use. /C2_0 38 0 R I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. 12 0 obj endobj endobj Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /Tabs /S To pump or not to pumpthat is a question that I hear in the lymphedema community. I?m 5? << /StructParents 2 I have lymphedema in my right arm, breast and axilla. Positive value shows an decrease in quality of life. endobj The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema. Words like new kind of pump, different than the old types, favorable studies, and Dr. /Rect [40.95 36 85.101 45.216] /Resources << ? /TT2 51 0 R HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. Positive value shows an increase in Function/Range of Motion. . Your email address will not be published. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. Its something Im passionate about. 2013; Vol. 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. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. endstream Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. /TT2 72 0 R I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. /Type /Page Both Ease of Use/Satisfaction will be assessed by survey. Learn More Take the steps now to help your head and neck cancer survivors. >> 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. >> endobj /Length 470 Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Study record managers: refer to the Data Element Definitions if submitting registration or results information. At-Risk Patient: Pressure Ulcers/Injuries, At-Risk Patient: Surgical Site Infections, Burns, Deep Partial-Thickness (Deep Second-Degree), Burns, Full-Thickness (Third- and Fourth-Degree), Burns, Superficial Partial-Thickness (Second-Degree), Peristaltic gradient sequential compression. Type of Use (Select one or both, as applicable) lXI . 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. >> /Font << /Resources << Tens of thousands of. I have it in both of my legs mostly in my thighs. 5 0 obj Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. /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] My husband?s pump system arrived yesterday. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. /Type /Catalog >> endstream & weigh 126 lbs. 3 0 obj Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. /Subtype /Link /CropBox [0.0 0.0 612.0 792.0] 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. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) did you sell it yet? Lymphat Res Biol, 2016. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. The Flexitouch System is not used for nor intended for use to treat cellulitis. 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. /MediaBox [0.0 0.0 612.0 792.0] /Font << Positive value shows an increase in swelling. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. /TT1 70 0 R /TT3 74 0 R I would contact your local news station that has a consumer investigation/help line. Advanced Techniques in Canine and Feline Neurosurgery - Brigitte A. Brisson,Andy Shores - Advanced Techniques in Canine and Feline Neurosurgery <br />An up-to-date discussion of the latest advanced neurosurgical techniques for dogs and cats <br />In Advanced Techniques in Canine and Feline Neurosurgery, a team of distinguished veterinary practitioners delivers an authoritative . /Font << Breast cancer and treatment in itself was an awful journey. /Resources << endobj 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. For more information, https://tactilemedical.com/about-us/. 2015 51 (431-437), 1. /Type /Page /Resources << For more information, https://tactilemedical.com/about-us/. 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 . 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. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. /ExtGState << Its amazing to me how little doctors know about lymphedema. Pain will be assessed using the VAS Pain Scale. 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. /CropBox [0.0 0.0 612.0 792.0] The lymphedema seen in patients treated for head . 4. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN /Type /Action Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Hi Sarah, I would suggest going to a clinic in your area where therapists specialize in care of lymphedema. It delivers a noninvasive therapy that patients can administer themselves at home. Its also a relief not to manually MLD my arm every night. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? /TT0 69 0 R Just wondering if you have any ideas of whom to contact on such a thing. Choosing to participate in a study is an important personal decision. Hope it works out. Actually they dont know much about lymphedema. /Rotate 0 Surprisingly, my therapists measurements showed minimal difference with previous measurements.
