I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. I was told purchased high priced left garments which I dont think I needed. 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. 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. 14(4): p. 198-205, 2. Read our, ClinicalTrials.gov Identifier: NCT04276454, Interventional Lymphat Res Biol, 2016. Most significantly was the reduction in my forearm. My skin appears more like the skin on my right arm. K-ZB: 2. UGH! !|.Sce@x*qkO NJ|PU:X5]?]_kPs:Cr.)rgKG$/N /Font << /Type /Page Has anyone else had any experience with this? Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. /Length 680 /Subtype /Link Text, image, video. 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. /Annots [39 0 R] where is the compassion for ill people that NEED certain healthcare to get better? Overview Product Features Details Benefits 12 0 obj ________________1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Minneapolis, MN 55416 USA stream 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. 2 0 obj /S /Transparency 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. endobj I didnt make a decision to purchase a pump that day. What really gripes me is that my nurse practitioner wouldnt even consider ordering one. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. You have reached the maximum number of saved studies (100). Since using the Flexitouch for almost a year, she had not experienced cellulitis. 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 . Hope it works out. << I dont know if it will make a difference. The pump has helped you achieve significant results. Negative value shows a decrease in Function/Range of Motion. /Length 412 /BS << Percent change is calculated by the difference between scores averaged at 6 months versus baseline. endstream Thanks. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. >> 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. For more information, https://tactilemedical.com/about-us/. 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. HTo0~G6)BjH7u Required fields are marked *. 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. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /XObject << /Length 450 Lymphatic drainage via pneumatic compression, Flexitouch Plus is the only FDA cleared pneumatic, compression device for head and neck cancer-related lymphedema and can be prescribed. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. If Im out late, I use it in the morning and then resume again in the evening. & weigh 126 lbs. << 1. Michelin Man came to mind as I stretched out on the couch. Buying a reconditioned machine saved me some money. % /StructParent 1 To evaluate symptoms based upon the EORTC HN35 questionnaire from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. >> I have it in both of my legs mostly in my thighs. The woman from Idaho said her arm was softer and found the machine easy to use. 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 /Pages /Length 470 My go to place when I need calming. Thumbs up for Flexi-Touch!! Toll-free: 1.833.3TACTILE (1.833.382.2845) I have lymphedema in my right arm, breast and axilla. >> I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. /Contents 36 0 R /Resources << I chatted with a woman from Tacoma and another from Idaho. 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. 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 ] 3701 Wayzata Blvd, Suite 300 endobj Numerous clinical studies show achievement of major clinical benefits and cost savings 11 0 obj Two years on pump controller and garments. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. I decided to purchase one without insurance. 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. /Filter /FlateDecode It was a blow to the life I had that I once had. G Bg4> +o_j-\#a4B5C;dOw[['q=oJ&9{4d`Jn"\u|MTbzzG,g L|F4/^z7D:tL$TrHxarg5>Lpp The specialist who placed the order asked for my inner thigh measurement, so she ordered a medium for the legs based on that. 4. 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. >> Tactile Systems Technology, Inc. Im a pianist and its become my safe place. /StructParents 7 k 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. A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. endobj Support Care Cancer (2020). 3. Pain will be assessed using the VAS Pain Scale. Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. (p <0.001)**Statistically Significant Results, (p=.016)**Statistically Significant Results, (p=0.008)**Statistically Significant Results, Late-effect fibrosis seven years post cancer treatment, Ability to control lymphedema at home (p=0.003_, Severity of soft tissue symptoms (p=0.008), Results are based on the median change in scores from baseline measurements, Ridner, S.H., Dietrich, M.S., Deng, J. et al. 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. I have skipped 1 or 2 days just 3 or 4 times since March. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. >> >> /CropBox [0.0 0.0 612.0 792.0] 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. /CropBox [0.0 0.0 612.0 792.0] Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Yes. The Flexitouch System is not used for nor intended for use to treat cellulitis. Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. >> 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 . I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. >> << Out of my sleeve, my 3/4 length sleeves arent as tight. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. They are usually called something like 7 on your side or Channel 3 helps you. Its amazing to me how little doctors know about lymphedema. Please remove one or more studies before adding more. /Im0 24 0 R For general information, Learn About Clinical Studies. It seems a lot of pumps are preprogrammed for the individual. Its something Im passionate about. /Type /Group /Tabs /S >> The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. I dont like that I have to do it but it has changed my legs back to normal. For an hour, the air chambers inflated and deflated sequentially, creating a wave-like motion. 2013; Vol. Listing a study does not mean it has been evaluated by the U.S. Federal Government. /TT2 51 0 R /MediaBox [0.0 0.0 612.0 792.0] Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Subject Quality of Life will be assessed using EORTC C30 questionnaire. I just came across this site about the Flexitouch Pneumatic Pump for Lymphedema. 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. 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. /TT0 69 0 R /Type /Page Tens of thousands of. /TT1 50 0 R /GS0 37 0 R I subsequently found out that Flexitouch had actually been around for several years but a new study had brought awareness to this pneumatic compression device or lymphedema pump. 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. Negative value shows a decrease in pain. 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. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months. While there is no cure, lymphedema can be effectively managed to relieve symptoms, prevent worsening, and lower the risk of skin damage and infection. >> Comfortable: Garments are made of soft, comfortable fabric while the dynamic pressure feels like a soothing massage. Explain the situation to them. 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. The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Dr. Arturo Gonzalez and Dr. Alton R. Johnson, Cathy Thomas Hess, BSN, RN, CWOCN and Dr. Lisa Gould, MD, PhD, FACS, IC-1200-WH Vascu-Ease Portable DVT System, Recommendations for Wounds After Flaps and Grafts, How to Leverage Technology to Improve Patient Education and Outreach, From Chronic to Closure: An Innovative Approach to Manage Challenging Wounds, Working Smarter, Not Harder: Strategies for Wound Management Success, How to Advance Complex Wounds Toward Healing, Implementing Wound Hygiene: A Stepwise Approach, Uncommon Wounds: Frostbite and Winter Woes, What Clinicians Should Know About Comorbidities and Complex Wounds. I just received it yesterday and Im super hopeful that it will help. I have a pump system left and right leg also stomach wraps. 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.

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