Tactile Medical Announces Enrollment of First Patient in Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? Numerous garment and program options to meet each patient's unique treatment needs See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /CropBox [0 0 612 792] 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. 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 /Parent 2 0 R 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch A healthy lymphatic system moves lymph fluid throughout the body. /Parent 2 0 R 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 . /Contents 75 0 R endobj 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. I did send them an email and asked them to look at your case again. Tactile Systems debuts Flexitouch head and neck lymphedema treatment /Rotate 0 Positive value shows an increase in Function/Range of Motion. 9 0 obj Phone: 1.612.355.5100 I am looking for a left arm garment for the flexitouch plus. /Parent 2 0 R 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. It takes just 32 minutes per day. Support Care Cancer (2020). Advanced pneumatic compression for treatment of lymphedema of the head endobj /Group << Talk with your doctor and family members or friends about deciding to join a study. /Annots [10 0 R 11 0 R 12 0 R] We were asked to improve the ease of donning . 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. Chronic Wounds Controller programmability allows preset programs - save up to three treatment programs and easily access each program from the large 7" color display. 18 0 obj 1(1): 114125. 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. 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. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 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. << Hopefully it will give me a better quality of life because I dont know what else to do at this point. 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. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. 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? !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ & weigh 126 lbs. The head & neck of non-human animals - | Cambridge SMART Vocabulary % >> She explained that compression pumps force air into sleeves with multiple chambers. /Rotate 0 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. >> /Type /Page The pump is called the Flexitouch System by Tactile Medical. Minneapolis, MN 55416 USA /CS /DeviceRGB /MediaBox [0.0 0.0 612.0 792.0] According to the Journal of American Medical Association (JAMA), In the 12 months following the receipt of the Flexitouch APCD: Cancer-related lymphedema patients demonstrated a: 79% decline in the rate of cellulitis, 29% reduction in the rate of out-patient hospital visits, a 30% reduction in rate of physical therapy, and a 37% reduction in lymphedema-related costs. Its been tough . Positive value shows an decrease in quality of life. I am a person who has kids and works as a hairstylist and loves gardening and working out and cooking. Positive value shows an increase in quality of life/overall health. My best to you. >> I use it every evening. He just never could get use to using it and being able to don the garments. x Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. D/N500187-000-00 Rev. /Type /Page Its something Im passionate about. My Experience with the Flexitouch Pneumatic Pump for Lymphedema 46(4): 480487. Learn More Take the steps now to help your head and neck cancer survivors. Yes, taking care of ones body requires several interventions. /Resources << /StructParents 8 Lymphedema 1. /Type /Group 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. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) If Im out late, I use it in the morning and then resume again in the evening. 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 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. << 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. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Rz:MzI6 For more information, https://tactilemedical.com/about-us/. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. The woman from Idaho said her arm was softer and found the machine easy to use. /Resources << I have a pump system left and right leg also stomach wraps. /Parent 2 0 R 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. endstream Talk with your doctor and family members or friends about deciding to join a study. 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^ Thanks. 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. /C2_1 55 0 R Choosing to participate in a study is an important personal decision. /XObject << Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. I only make 12k per year so its not like I can afford anything. Medical Device Innovation | Nottingham Spirk Design Collaborative I wonder if pumps can be reprogrammed. The woman from Idaho said her arm was softer and found the machine easy to use. Phone: 1.612.355.5100 NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( >> >> /C2_0 38 0 R The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. 14(4): p. 198-205, 2. I was told purchased high priced left garments which I dont think I needed. If you still have the system, I am interested. endobj Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. They wanted me to come there three times a week for 3 hours to be wrapped and have therapy. Everything in my life that I do and love and I am passionate about invloves using my hands and arms. The feeling of devloping a chronic disease after surviving cancer was almost debilitating. It delivers a noninvasive therapy that patients can administer themselves at home. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Hi Kristie, Thank you for sharing your story. /Rotate 0 Percent change is calculated by the difference between scores averaged at 6 months versus baseline. 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. /Font << 1. /CS /DeviceRGB The chambers take turns filling up with air with the goal of moving excess fluid out of the affected limb and returning it to the cardiovascular system. The Head & Neck Program is just 32 minutes long. 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 . Required fields are marked *. Hi Jaime, Im hopeful that your new pump will provide relief. /Pages 2 0 R Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. Positive value shows an increase in symptoms/problems. [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. 12 0 obj >> Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. I used it a few times and Im good now. /StructParents 0 Filter by. Toll-free: 1.833.3TACTILE (1.833.382.2845) I have it in both of my legs mostly in my thighs. Last updated March 2021. I am delighted to say that hubbys minor leg swelling, from his diabetes and hefty build, are significantly less after Flexi-Touch was added to his health regime by the Diabetes Clinic at the VA Hospital. /Font << 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. 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 head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. To pump or not to pumpthat is a question that I hear in the lymphedema community. /Im0 60 0 R First of all I cant drive, and second I have to pay a $60 copay every time I go. /TT1 50 0 R 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). You have reached the maximum number of saved studies (100). Has anyone else had any experience with this? Please cross your fingers for me that this works. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276454. /Tabs /S Words like new kind of pump, different than the old types, favorable studies, and Dr. 1. endobj Since using the Flexitouch for almost a year, she had not experienced cellulitis. 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. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5. /MediaBox [0 0 612 792] document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. /URI (http://www.fda.gov/) endobj My go to place when I need calming. >> /ProcSet [/PDF /Text /ImageC] /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) /TT1 70 0 R My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. My interest in pumps suddenly skyrocketed! Thank you for writing. 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.. Ideas? The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. Since using the Flexitouch for almost a year, she had not experienced cellulitis. The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. 16 0 obj The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. /Type /Page The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Hi Karyn, I will post your comment and see if Sarah still has the pump available. /TT3 72 0 R Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Clinical Trial on Head and Neck Cancer: Flexitouch Plus system Its also a relief not to manually MLD my arm every night. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. >> Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. /Rotate 0 << I really need this system and had such desperate hope. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. (Clinical Trial). by Flexitouch. 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. If anyone has one, or knows of one, please contact me. /Rotate 0 Im only 44 years old , and I have kids that need mom back. I wanted to talk to some people who had actually used the pump. << This is not anadvertisement for Flexitouch.). It was a blow to the life I had that I once had. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. 3 0 obj Actually they dont know much about lymphedema. /Font << /Subtype /Link /Type /Page Adams, KE, Rasmussen JC, Darne C, et al. I was rather startled at how wrapped up I was. Thank you for sharing your husbands success with a pump. /A << Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /Type /Group /ExtGState << >> /Length 412 Im sorry for the experience you had with Tactile Medical. << /W 0 >> >> endobj Lymphat Res Biol, 2016. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. 2013; Vol. 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. /Parent 2 0 R endobj 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 . 3. /TT0 23 0 R In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC.
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