. The best thing is that after only 6 days of pumping my breast and axilla is are much smaller and I have no dull grating pain for many hours in the day! /Type /Page 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. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. >> They will reach out to Flexitouch in the process of creating a segment for the news. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. My skin appears more like the skin on my right arm. /TT2 74 0 R Talk with your doctor and family members or friends about deciding to join a study. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. HTn0+xIt XLRIiE)k!SS14U
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__Z2om[]n&x*nAa(0A\0 Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. /TT2 71 0 R >> Sci-Hub | Pembrolizumab plus cetuximab in patients with recurrent or /Parent 2 0 R 2 0 obj 7nwJ@6]?t~.} The Flexitouch system treats lymphedema, which causes swollen limbs and dangerous infections. 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. /MediaBox [0 0 612 792] /Type /Action
I have been having weekly physical therapy to help with lymphedema and range of motion issues. >> Please remove one or more studies before adding more. The pump has helped you achieve significant results. Numerous garment and program options to meet each patient's unique treatment needs stream
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Keep sharing your story. >> 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 Both Ease of Use/Satisfaction will be assessed by survey. Simultaneous bilateral therapy allows the patient to treat both legs at once and save overall patient treatment time 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. HMs0{:a& f i= %e:YIf4x]i}_Ep{;_.{B!E0D[ /ExtGState << The Flexitouch Plus system should not be used on patients with one or more of the following conditions: 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. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. /Font << Medical Device Innovation | Nottingham Spirk Design Collaborative Breast cancer and treatment in itself was an awful journey. /Type /Group Adjustable, easy-to-put-on-and-take-off, garments fit the unique anatomical contours of each patient, providing targeted, individualized treatment 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.. I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. /GS0 37 0 R 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. 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. Daily storage of Flextouch system - Lymphedema - Inspire An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. /Font << I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. 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. /C2_1 55 0 R /Length 470 Reading or watching TV are the activities Im able to do while Im being treated. >> During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. Flexitouch . Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? /StructParents 6 ? Im only 44 years old , and I have kids that need mom back. Lymphat Res Biol. I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. It takes just 32 minutes per day. Percentage of each response captured. Ridner, S.H., Dietrich, M.S., Deng, J. et al. Type of Use (Select one or both, as applicable) lXI . 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. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. /Rotate 0 Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts Head and Neck Cancer Lymphedema - Tactile Medical 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. /Rotate 0 So we appealed 3 times. 4?Cz RlRKj~7>@X\CFIB4\G+Qo{ (yD6X+6tB&KsM. )]Cw7*1$Teyz. Having to search it all out including bandaging and reducing myself, learning from You Tube, finding supplies online and dealing with physical therapists and oncologists and radiation oncologists who dont know anything about this chronic disease and putting all the pieces together myself because there are people to help but no one knows where they are was emotially depressing. /W 0 The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Negative value shows a increase in quality of life.
/Contents 73 0 R No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. HTMO0WKwfCB R+,Pq%j7U.h|AzPM]%YR|dZERH dHkeh5.
4? endobj >> A healthy lymphatic system moves lymph fluid throughout the body. 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. 3 total ratings, 2 with reviews There was a problem filtering reviews right now. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. /Filter /FlateDecode I just received the flexitouch plus, but I think the leg garments are too big. 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. Hi Wandalynn . Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional
The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. /C2_0 48 0 R I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. /Parent 2 0 R /URI (http://www.fda.gov/) 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). 2013; Vol. /TT0 22 0 R 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. Top reviews. >> >> She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Toll-free: 1.833.3TACTILE (1.833.382.2845) Thank you for sharing your husbands success with a pump. I bought a Tactile flexi-touch plus system from a Veteran on Ebay for $200. Hi Karyn, I will post your comment and see if Sarah still has the pump available. /Type /Page 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. Percent change is calculated by the difference between swelling measurements 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). endstream /Filter /FlateDecode One pump I know of that does not have preprogramming is a Normatec pump by Hyperice. 1. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. 10 0 obj Toll-free: 1.833.3TACTILE (1.833.382.2845) 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. 5. /TT1 23 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. Why Should I Register and Submit Results? >> Managing my lymphedema requires attention and an assortment of tools. >> Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. It takes just 32 minutes per day. /Resources << /TT1 50 0 R >> {%AIqEWRA>, I use it everyday for an hour. 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. content.edgar-online.com Tactile Systems Technology, Inc.
I wish you success! << tm233510-5_424b5 - none - 7.6719207s 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. 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. I didnt need a lymphedema physical therapist but too much to explain here. 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.
Positive value shows an increase in symptoms/problems. My therapist wasnt very keen on the use of these pumps and stated that they can sometimes hinder rather than help lymphedema. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile.
It was a blow to the life I had that I once had. /TT1 70 0 R /Contents 75 0 R Many head and neck cancer survivors are faced with an additional challenge: lymphedema. ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Tactile Systems Technology, Inc. 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. /StructParent 1 /MediaBox [0 0 612 792] /ProcSet [/PDF /Text /ImageC] /TT2 51 0 R 3701 Wayzata Blvd, Suite 300 eIb? 10-K: TACTILE SYSTEMS TECHNOLOGY INC - MarketWatch /S /URI (Clinical Trial). 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. It delivers a noninvasive therapy that patients can administer themselves at home. /C2_0 38 0 R Sign up today for your free Reader Account. Flexitouch Plus helps reduce swelling and relieve symptoms of head and neck lymphedema with effective treatments that are: Consistent: Unlike manual lymphatic drainage (MLD), effective treatment doesnt depend on patient technique or ability. Tactile Medical Announces Enrollment of First Patient in >> Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. In September 2016, we received 510(k) clearance from the FDA for the Flexitouch system in treating lymphedema of the head and neck. /TT1 70 0 R Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. /MediaBox [0.0 0.0 612.0 792.0] by Flexitouch. Last updated March 2021. (6Kjw_XGz'g &p 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.. << Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. 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. They are in contact with patients who could benefit from a pneumatic pump. Minneapolis, MN 55416 USA Flexitouch Pd32-u Lymphedema Treatment System Pump 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. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. /S /Transparency >> /Rotate 0 I did send them an email and asked them to look at your case again. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. << Support Care Cancer (2020). I hate to let such an important piece of equipment sit and waste when so many people could benefit from it. It delivers a noninvasive therapy that patients can administer themselves at home. Rz:MzI6 Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Minneapolis, MN 55416 USA The head & neck of non-human animals - | Cambridge SMART Vocabulary 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. 12 0 obj Tactile Systems gets enrollment underway in Flexitouch Plus lymphedema /TT0 69 0 R Last updated March 2021. I chatted with a woman from Tacoma and another from Idaho. I wonder if pumps can be reprogrammed. My lymphedema therapist also told me that the pumps werent worth it. >> 14(4): p. 198-205, 2. /TT3 59 0 R The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Thanks. >> Looking at his ankles there IS no swelling now. I have have been blessed to have the Tactile newest machine for lymphedema in both my legs. >> 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. 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. My go to place when I need calming. Negative value shows a decrease in Function/Range of Motion. /TT0 69 0 R >> 7 0 obj . 14 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. 13 0 obj 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 leg garments that I received are for a much taller person. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. >> endstream /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] Percent change is calculated by the difference between scores averaged at 6 months versus baseline. Its New, Your email address will not be published. Hi Wally, Hope someone is able to meet your request. /Parent 2 0 R 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.
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