flexitouch plus head and neck

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. 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. The pump has helped you achieve significant results. trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. When I first went to physical therapy, she was running through some more common contibuters to swelling. Overview Product Features Details Benefits Flexitouch Pd32-u Lymphedema Treatment System Pump HTo0~G6)BjH7u (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. Legal Notice Regarding Forward-Looking Statements: This release contains forward-looking statements. Lymphat Res Biol. << A Pilot Study to Evaluate the Feasibility and Potential Effectiveness The Head & Neck Program is just 32 minutes long. (6Kjw_XGz'g &p /Type /Page O ce they are used the government wont always them to use them on another. Flexitouch Plus is an advanced intermittent pneumatic compression device (lymphedema pump) that gives patients a comfortable and convenient way to self-manage lymphedema and non-healing venous leg ulcers. /Length 450 endobj 16 0 obj The pump is awesome works for me iam walking better @ standing the swelling goes away!!! /ProcSet [/PDF /Text /ImageC] A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device. 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! I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. 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. 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. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. 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. What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. /Im0 24 0 R As one Flexitouch woman put it, its like finally getting a dishwasher to do your dishes. Karaca-Mandic P, Hirsch AT, Rockson SG, et al. >> 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. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. /Group << 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. I have lymphedema due to a mastectomy and 15 lymph nodes removed from my left arm. Support Care Cancer (2020). >> /URI (http://www.fda.gov/) Words like new kind of pump, different than the old types, favorable studies, and Dr. >> Swelling will be assessed using the ALOHA measurement protocol. 9 0 obj Percent change is calculated by the difference between scores averaged at 6 months versus baseline. This all proves to me that my Flexitouch is moving lymphatic fluid out of my lymphedema affected areas. 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. Ideas? (Note: There are other well regarded pumps on the market. Its also a relief not to manually MLD my arm every night. 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/. The Flexitouch Plus system is clinically proven to decrease swelling and improve swallowing. /Filter /FlateDecode I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. /Font << Hi Deborah, How wonderful you have had such positive success with your pump. 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? 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. %PDF-1.4 Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. /Contents 53 0 R Its amazing to me how little doctors know about lymphedema. I have had a DMX, chemo, radiation and will be taking medication for the next 10 years that causes swelling. 1. Thank you for sharing your husbands success with a pump. 11 0 obj The pump is called the Flexitouch System by Tactile Medical. 2 0 obj Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed. The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and to treat head and neck lymphedema. D/N500187-000-00 Rev. 2016;14(4):198205. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. Please remove one or more studies before adding more. https://doi.org/10.1007/s00520-020-05540-8, Call us at1.833.3TACTILE (1-833-382-2845) Required fields are marked *. For a better long-term outcome, help head and neck cancer patients address lymphedema symptoms from the convenience of their homes. Support Care Cancer (2020). I was rather startled at how wrapped up I was. Support Care Cancer (2020). Support Care Cancer (2020). It takes just 32 minutes per day. 6 0 obj /Group << 1 0 obj Sign up today for your free Reader Account. >> Hi Karyn, I will post your comment and see if Sarah still has the pump available. Negative value shows a decrease in pain. Is there any evidence that a tissue expander has ever ruptured due to using a FlexiTouch machine? >> 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 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. I have a pump system left and right leg also stomach wraps. In my home, Alexis helped me slip into a padded bolero type jacket with a long sleeve for my left arm. 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) Im diligent in taking care of myself because I want to continue to pursue activities that enrich my life. /C2_0 38 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. How customer reviews and ratings work See All Buying Options. A friend who was using the Flexitouch for lymphedema in her legs directed me to Alexis, the sales representative for Flexitouch. endobj /Subtype /Link /Parent 2 0 R The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. My Experience with the Flexitouch Pneumatic Pump for Lymphedema. Toll-free: 1.833.3TACTILE (1.833.382.2845) Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. I have one new for sale. Buying a reconditioned machine saved me some money. 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. Flexitouch Plus provides flexible program options. The woman from Idaho said her arm was softer and found the machine easy to use. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. Keep in touch! The woman from Idaho said her arm was softer and found the machine easy to use. >> /Rect [90.257 252.64 421.33 266.44] I have been denied from my insurance company 3 times to get this for my lymphedema that is all over my body. /Length 470 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). It delivers a noninvasive therapy that patients can administer themselves at home. endobj k Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. /Rotate 0 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. Rz:MzI6 /S /Transparency 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. Any circumstance where increased lymphatic or venous return is undesirable Sort by. Flexitouch Plus - Treat Head & Neck Swelling At Home with This 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. All subjects will receive a single intervention. /TT1 57 0 R 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. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Im sorry for the experience you had with Tactile Medical. /StructParents 7 between head and neck cancer and lymphedema. /Type /Catalog /C2_0 21 0 R Why Should I Register and Submit Results? The swelling can be both internal and external and cause pain, reduced range of motion and difficulty swallowing, speaking and breathing. Daily storage of Flextouch system - Lymphedema - Inspire The Flexitouch Plus system is clinically proven to stimulate the lymphatic system and aids treatment of head and neck lymphedema. Heart failure (acute pulmonary edema, decompensated acute heart failure) 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. Explain the situation to them. /CropBox [0 0 612 792] >> In 2017, Tactile Medical launched a Flexitouch system designed for the treatment of lymphedema of the head and neck at home. endobj In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. /CropBox [0.0 0.0 612.0 792.0] I didnt need a lymphedema physical therapist but too much to explain here. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. /TT2 58 0 R Now cancer survivors can comfortably and conveniently self-manage their lymphedema at home. Looking at his ankles there IS no swelling now. The garments have already been measured for me at the PT office but the Company wont allow me to purchase them from them. Please write back in a month or so and let us know your progress. /S /URI 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. No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. Our Solutions for Head and Neck - Tactile Medical It was up to me to piece it together. >> 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. Fax: 1.866.435.3949, Flexitouch, Actitouch, Entre and HEALING RIGHT AT HOME are all trademarks or registered trademarks of Tactile Medical. Phone: 1.612.355.5100 Because of the COVID-19 I will have to learn the ropes online because Tactile is not making home visits. Biomedical Optics Express. !(G32Lqk PPr!, L1:n}^w!Y/ W}~^ZcA?c/UM/z)l}a#}UTG/$7~Jsl"[!kklmemzP|4C:vKbkyf;C?.6ZeG FnM (#5_- pZ Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. See instructional videos Key Features Get the brochure Daily 32-minute treatment cycle Mild dynamic pressure Comfortable and easy to use /Parent 2 0 R Pain will be assessed using the VAS Pain Scale. did you sell it yet? I have been having weekly physical therapy to help with lymphedema and range of motion issues. Actually they dont know much about lymphedema. {%AIqEWRA>, 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. Its been tough . endobj /W 0 See the clinical benefit of Flexitouch Plus FEES Study 1 Swelling six week post cancer treatment FEES Study 2 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! 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. Investors and security holders are urged to read these documents free of charge on the SECs website at http://www.sec.gov. It delivers a noninvasive therapy that patients can administer themselves at home. But in reading the users manual I found that you should consult your physician before using a FlexiTouch garment that covers your chest if you have a tissue expander. Adding the Flexitouch compression pump to my daily lymphedema care regime has helped me attain that goal. /CS /DeviceRGB My skin appears more like the skin on my right arm. Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts

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