11 0 obj /Count 7 /URI (http://www.fda.gov/) 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. /C2_0 54 0 R Explain the situation to them. 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. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN It has made my life miserable. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) /S /URI The feeling of devloping a chronic disease after surviving cancer was almost debilitating. k I was told purchased high priced left garments which I dont think I needed. 3. I wonder if pumps can be reprogrammed. 2010; Vol. I would be interested to hear how your husbands experience with his new pump. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) My interest in pumps suddenly skyrocketed! 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. | Source: Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Keep sharing your story. /F 4 /Tabs /S document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); This field is for validation purposes and should be left unchanged. 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. 0001437749-23-004978 - 4 - Tactile Systems Technology, Inc. Muluk SC, Hirsch AT, Tafe EC. Flexitouch Pd32-u Lymphedema Treatment System Pump. 17 0 obj Sci-Hub | Pembrolizumab plus cetuximab in patients with recurrent or Try contacting different people. >> Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. /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] >> Hi Jaime, Im hopeful that your new pump will provide relief. 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. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /Rect [40.95 36 85.101 45.216] 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. For general information, Learn About Clinical Studies. 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 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. /Annots [39 0 R] Both Ease of Use/Satisfaction will be assessed by survey. 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. The leg garments that I received are for a much taller person. 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. 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. Pembrolizumab plus cetuximab in patients with recurrent . /F 4 /Font << /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 Medical Announces Enrollment of First Patient in - Yahoo! I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 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. 2008-2023 HMP Global, Inc. All rights reserved. Support Care Cancer (2020). /GS0 37 0 R 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 {%AIqEWRA>, The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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! D/N500187-000-00 Rev. Why Should I Register and Submit Results? Its brand new, used 1 time. endstream 1. content.edgar-online.com 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. /Type /Page The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. << 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. The warranty was the same as a new machine. * American Society of Clinical Oncology 1. /TT0 49 0 R stream 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. +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 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. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. H]O0+=) ES Rz:MzI6 >> 10 0 obj 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch endobj The woman from Idaho said her arm was softer and found the machine easy to use. did you sell it yet? When she said piano I froze. My Experience with the Flexitouch Pneumatic Pump for Lymphedema Advanced Techniques in Canine and Feline Neurosurgery Refer to the Legal Notice for express terms of use. A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Positive value shows an increase in symptoms/problems. >> Phone: 1.612.355.5100 /Type /Action I?m 5? 1. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. Flexitouch Pd32-u Lymphedema Treatment System Pump Has anyone else had any experience with this? 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. Heart failure (acute pulmonary edema, decompensated acute heart failure) Flexitouch Plus for Head and Neck; Flexitouch User Guide and Additional Information for Head and Neck; Upper Body. 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. 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. Lymphat Res Biol. Phone: 1.612.355.5100 Support Care Cancer (2020). Daily storage of Flextouch system - Lymphedema - Inspire endobj The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /Filter /FlateDecode 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. Tens of thousands of. The Flexitouch System is not used for nor intended for use to treat cellulitis. It delivers a noninvasive therapy that patients can administer themselves at home. 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. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. I have a uniboot compressions on both of my calves. My lymphedema therapist also told me that the pumps werent worth it. 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 a pump system left and right leg also stomach wraps. The whole process, though limiting my ambulation, was comfortable and relaxing. 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. Top reviews. >> 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. Positive value shows an increase in swelling. 2015 51 (431-437), 1. 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. Numerous clinical studies show achievement of major clinical benefits and cost savings PDF Lauren Barnes - Food and Drug Administration Developing Lymphedema and not being able to get the help that I neededwas awful. The pump has helped you achieve significant results. 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. Flexitouch Pd32-u Lymphedema Treatment System Pump I have lymphedema in my right arm, breast and axilla. When this disease occurs in the head and neck, which is common after cancer treatments, quality treatments have been fewuntil now. Hi Wally, Hope someone is able to meet your request. I have the Flexitouch Plus system (legs x2, arms/shoulder x2, lower and upper trunk pieces, and head/neck piece). EJVES. >> endobj Deng J, et al. 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. Lymphat Res Biol, 2016. 2015;151(11):11871193. /Parent 2 0 R I used it a few times and Im good now. Tactile Systems debuts Flexitouch head and neck lymphedema treatment YIgJ_P;}wwSk}x NZ[*EO1q(A=x> b\-Vxk(q,lo*Pi;~D1-(]pp+`~8cY &JS1(wD"J&E~WZ'OZ !! /Rotate 0 >> A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Choosing to participate in a study is an important personal decision. /Pages 2 0 R 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. >> To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The pump is called the Flexitouch System by Tactile Medical. The lymphedema seen in patients treated for head . Hi Karyn, I will post your comment and see if Sarah still has the pump available. /XObject << The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. 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 . Michelin Man came to mind as I stretched out on the couch. The study evaluated use of the Flexitouch System as a tool for the treatment of lymphedema.
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