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>> An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. 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. & weigh 126 lbs. /CropBox [0 0 612 792] Negative value shows a decrease in swelling. stream The pump is called the Flexitouch System by Tactile Medical. I know many others can as well. /Parent 2 0 R Im a pianist and its become my safe place. Toll-free: 1.833.3TACTILE (1.833.382.2845) 2. Thank you for sharing and being an advocate for lymphedema! /Type /Group Clinical Trial on Head and Neck Cancer: Flexitouch Plus system << As with any chronic, progressive condition, early intervention and practical tools for daily management produce the best results. << 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. Lymphedema can be debilitating and make it hard for survivors of head and neck cancer to start enjoying life again. /TT1 57 0 R Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Since using the Flexitouch for almost a year, she had not experienced cellulitis. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. 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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558672. /Type /Catalog Numerous clinical studies show achievement of major clinical benefits and cost savings I have been having weekly physical therapy to help with lymphedema and range of motion issues. /TT0 22 0 R 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. /TT1 50 0 R 2 0 obj /TT0 69 0 R When I first went to physical therapy, she was running through some more common contibuters to swelling. << 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. /Group << /Type /Page 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! Managing my lymphedema requires attention and an assortment of tools. >> 2016;14(4):198205. What really gripes me is that my nurse practitioner wouldnt even consider ordering one. Except for my wrist, all my measurements showed reduction. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. He will recline, watch tv, or sometimes he is so relaxed he briefly dozes off. Minneapolis, MN 55416 USA Flexitouch Pd32-u Lymphedema Treatment System Pump. 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. tm233510-5_424b5 - none - 7.6719207s 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/. >> Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. So for almost every night for the next seven years I sat down and performed MLD on my left arm. I have one new for sale. Im sorry for the experience you had with Tactile Medical. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. endobj Swelling will be assessed using the ALOHA measurement protocol. The warranty was the same as a new machine. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /W 0 Assessment and measurement of head and neck lymphedema: State-of-the-science and future directions. 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 >> 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. 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. << 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. 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^ Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. Tactile Medical braces for new Medicare rules that will tighten access Its amazing how we are communicating so much more through technology because of Covid. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. 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. /C2_0 38 0 R 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. I need help but theres a no return policy. << 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. How customer reviews and ratings work See All Buying Options. The purpose of this study was to evaluate the feasibility and efficacy regarding the use of the FT in HNC survivors with lymphedema. My interest in pumps suddenly skyrocketed! /Subtype /Link )XXAc21Z(VAP\+swqri#1 c8m8w5;#"iYWd6u&~7_Z]V}{JAlv-s+b~vOztn12SA|xG)fjwjBYn6 X=+o\U$(F>4AxPi^gE5 f/]zR3N1D]-/A->byyo/4PMv The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use My Experience with the Flexitouch Pneumatic Pump for Lymphedema >> endobj S 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 Support Care Cancer (2020). 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. My physical therapist recommended the FlexiTouch Plus machine, and my new machine arrived this week. 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. /S /Transparency /MediaBox [0.0 0.0 612.0 792.0] /TT3 59 0 R /TT3 72 0 R https://doi.org/10.1007/s00520-020-. /Length 450 What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /CropBox [0.0 0.0 612.0 792.0] I am in very early stages but it will only get worse if not taken care of, so be kind and good to yourself. >> Lymphat Res Biol. /Tabs /S /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 Negative value shows a decrease in symptoms/problems. /TT1 70 0 R Empowering patients to self-manage their head and neck lymphedema from home for improved outcomes and a better quality of life. I have it in both of my legs mostly in my thighs. /BS << 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. 12 0 obj /S /Transparency I have lymphedema near globally at this point and am trying to obtain coverage via insurance. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /Tabs /S Learn how your comment data is processed. 18 0 obj To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Flexitouch Plus - Treat Head & Neck Swelling At Home with This