Tactile Medical is a leader in developing clinical evidence to support the use of our products. We actively collaborate with medical professionals, researchers and industry groups. We have a strong commitment to developing clinical evidence with nationally and internationally recognized clinicians and researchers.
Clinical research is fundamental to Tactile Medical’s mission of advancing the standard of at-home treatment of lymphedema and venous ulcers. Our commitment to research has resulted in dozens of peer-reviewed clinical studies and scholarly articles—more than any other compression pump manufacturer. In partnership with medical researchers and centers of excellence, Tactile Medical demonstrates the clinical, patient and cost benefits of the Flexitouch® System and Actitouch™ Adaptive Compression Therapy system in treating chronic swelling.
Flexitouch – The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients with Lymphedema
Authors: Pinar Karaca-Mandic, PhD, Alan T. Hirsch, MD, Stanley Rockson, MD, and Sheila Ridner, PhD, RN
Published: Journal of American Medical Association (JAMA) Dermatology, October 2015
Examine the impact of the Flexitouch advanced pneumatic compression device (APCD) on 12 month clinical outcomes and healthcare costs in a privately insured population of lymphedema patients.
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. 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.
Lymphedema is a chronic disease associated with increased rates of cellulitis and adverse clinical events. The Flexitouch System is the only pneumatic compression device clinically proven to reduce the incidence of cellulitis, stimulate the lymphatic system, and help to reduce healthcare costs in lymphedema patients.
Flexitouch – Pneumatic Compression Improves Quality of Life in Patients with Lower-Extremity Lymphedema
Authors: Sheila N. Blumberg, MD, MS, Todd Berland, MD, Caron Rockman, MD, Firas Mussa, MD, Allison Brooks, MSN, RN-BC, Neal Cayne, MD, Thomas Maldonado, MD
Published: Annals of Vascular Surgery. 2015; Vol. 29(4): 628-629
Lymphedema is an incurable and disfiguring disease secondary to excessive fluid and protein in the interstitium as a result of lymphatic obstruction. Pneumatic compression (PC) offers a novel modality for treatment of lymphatic obstruction through targeting lymphatic beds and mimicking a functional drainage system. The objective of this study is to demonstrate improved quality of life in patients with lower-extremity lymphedema.
A total of 100 patients met inclusion criteria. At presentation, 70% were female with a mean age of 57.5 years. Secondary lymphedema was present in 78%. Mean length of PC use was 12.7 months with a mean of 5.3 treatments per week. Ankle and calf limb girth decreased after PC use, (28.3 vs. 27.5 cm, p = 0.01) and (44.7 vs. 43.8 cm, p = 0.018), respectively. The number of episodes of cellulitis and ulcers pre- and post-PC decreased from mean of 0.26 – 0.05 episodes (p = 0.002) and 0.12 – 0.02 ulcers (p = 0.007), respectively. Fourteen percent had concomitant superficial venous insufficiency, all of whom underwent venous ablation. Overall 100% of patients reported symptomatic improvement post-PC with 54% greatly improved. 90% would recommend the treatment to others.
PC improves symptom relief and reduces episodes of cellulitis and ulceration in lower-extremity lymphedema. It is well tolerated by patients and should be recommended as an adjunct to standard lymphedema therapy. Screening for venous insufficiency is recommended.
Flexitouch – Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes
Authors: Satish C. Muluk, MD, Alan T. Hirsch, MD, and Elise C. Taffe, MD
Published: European Journal of Vascular and Endovascular Surgery. 2013; Vol. 46(4): 480–487
Examine the effectiveness of an advanced pneumatic compression device (APCD) in reducing limb volume (LV), and to evaluate clinician and patient-reported outcomes.
90% of APCD-treated patients experienced a significant reduction in LV with 35% enjoying a reduction >10%. Mean LV reduction was 1,150 mL or 8% (p <.0001). Greater baseline LV and BMI were strong predictors of LV reduction (p <.0001). Clinician assessment indicated that the majority of patients experienced improvement in skin fibrosis and function. Patient-reported outcomes showed a significant increase in ability to control lymphedema through APCD treatment, with an increase in function and a reduction in the interference of pain. 66% were “very satisfied” with the APCD treatment.
APCD use is associated with consistent reductions in LV, with favorable patient-reported outcomes. Results demonstrate that reduction in LV and pain, combined with functional improvement and patient satisfaction can be achieved, providing tangible benefit for lower extremity patients.
Flexitouch – A Randomized Controlled Trial Comparing Two Types of Pneumatic Compression for Breast Cancer-Related Lymphedema Treatment in the Home
Authors: Caroline E. Fife, MD, Suzanne Davey, OTR/L CLT-LANA, Erik Maus, MD, Renie Guilliod, MD, and Harvey N. Mayrovitz, PhD
Published: Supportive Care in Cancer. 2012; Vol. 20(12): 3279–3286
Pneumatic compression devices (PCDs) are used in the home setting as adjunctive treatment for lymphedema after acute treatment in a clinical setting. PCDs range in complexity from simple to technologically advanced. The objective of this prospective, randomized study was to determine whether an advanced PCD (APCD) provides better outcomes as measured by arm edema and tissue water reductions compared to a standard PCD (SPCD) in patients with arm lymphedema after breast cancer treatment.
The APCD-treated group experienced an average of 29% reduction in edema compared to a 16% increase in the SPCD group. Mean changes in TDC values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group.
This study suggests that for the home maintenance phase of treatment of arm lymphedema secondary to breast cancer therapy, the adjunctive treatment with an APCD provides better outcomes than with a SPCD.
Flexitouch – Direct Evidence of Lymphatic Function Improvement after Advanced Pneumatic Compression Device Treatment of Lymphedema
Authors: Kristen E. Adams, PhD, John C. Rasmussen, PhD, Chinmay Darne, PhD, I-Chih Tan, PhD, Melissa B. Aldrich, PhD, Milton V. Marshall, PhD, Caroline E. Fife, MD, Erik A. Maus, MD, Latisha A. Smith, MD, Renie Guilloid, MD, Sunday Hoy, Esq., and Eva M. Sevick-Muraca, PhD
Published: Biomedical Optics Express. 2010; Vol. 1(1): 114–125
Lymphedema affects up to 50% of all breast cancer survivors. Management with pneumatic compression devices (PCDs) is controversial, owing to the lack of methods to directly assess benefit. This pilot study employed an investigational, near-infrared (NIR) fluorescence imaging technique to evaluate lymphatic response to PCD therapy in normal control and breast cancer-related lymphedema (BCRL) subjects.
The rate of lymphatic propulsion increased during and post-treatment as compared to pre-treatment. Vessel recruitment was seen in 2 of the 3 control subjects. Lymphatic function improved in all control subjects, as indicated through increased rates of lymphatic propulsion and/or vessel recruitment. Statistically significant differences were evident between the rates of propulsion in the treated arms pre- and post-treatment. The rate of propulsion tended to increase in the untreated arms of control subjects, not only after Flexitouch treatment, but also during the initial preparation phases, suggesting improved systemic lymphatic drainage associated with advanced Flexitouch treatment.
This study presents direct evidence that Flexitouch treatment improves lymphatic function systemically both during and after treatment.
Flexitouch – Home Based Lymphedema Treatment in Patients With and Without Cancer-Related Lymphedema
Authors: Sheila Ridner, PhD, RN, Elizabeth McMahon, PhD, Mary Dietrich, PhD, and Sunday Hoy, Esq.
Published: Oncology Nursing Forum. 2008; Vol. 35(4): 671–680
To compare treatment protocol adherence, satisfaction, and perceived changes in emotional and functional status between patients with lymphedema with and without cancer using the home-based Flexitouch systems for lymphedema self-care.
Participants without cancer were more adherent to the prescribed protocol. Both groups were satisfied with the system, perceived it to be effective, and reported improvement in physical and emotional status. Participants’ use of professional manual lymphatic drainage (MLD) therapy, self-MLD, and bandaging declined after they initiated use of the Flexitouch system.
90% of patients using the Flexitouch system were satisfied with the device and perceived it to be beneficial in management of their lymphedema.
Flexitouch – Flexitouch System is Well Tolerated and Shows Significant Edema Reduction in Head and Neck Cancer Patients
Authors: Harvey N. Mayrovitz PhD, Shelly Ryan PT, CLT-LANA &, James M. Hartman MD
Published: Head & Neck: Journal of the Sciences and Specialties of the Head and Neck
To assess the ease of application, garment fit and comfort, and treatment comfort of a novel advanced pneumatic compression system specifically designed to treat patients with head and neck lymphedema. Secondary purposes were to assess safety and acute edema changes after a single treatment.
One 32 minute treatment session produced overall significant reductions in facial composite measurement (p<.001) and neck composite measurements (p<.001) with no adverse events. A 2% composite reduction was achieved in 43% of patients for face measurements, and 20% for neck measurements after a single treatment session. A majority of the patients (82%) reported the treatment was comfortable; most patients (61%) reported feeling better after treatment, and nearly all (93%) reported that they would be likely to use this therapy at home. Most of the patients (70%) demonstrated independent ability to don the garments properly; with the remaining 13 (30%) required minimal assistance. Nearly all (95%) of the subjects demonstrated an independent ability to doff the garments with only 2 (5%) needing minimal assistance.
Results demonstrate the treatment to be safe, easy to use, and well tolerated, while showing statistically significant and clinically important edema reduction after a single initial treatment.
Flexitouch – A Pilot, Prospective Evaluation of a Novel Alternative Maintenance Therapy of Breast Cancer-Associated Lymphedema
Authors: Olivia Wilburn, MD, PhD, Paul Wilburn, and Stanley G. Rockson, MD
Published: BMC Cancer. 2006; Vol. 6(1): 84–89
Prospective investigations of complete decongestive lymphatic physiotherapy (CDPT), including manual lymphatic drainage (MLD), have validated the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema. However, CDPT demands substantial time and effort from patients to maintain these benefits; the treatments are not always well-accepted, and patients may suffer from a deterioration in quality-of-life or a time-dependent loss of initial treatment benefits. A new device designed for home use by the patient, the Flexitouch system, has been developed to mechanically simulate MLD. We have undertaken a prospective, randomized, crossover study of the efficacy of the Flexitouch system, when compared to massage, in the self-administered maintenance therapy of lymphedema.
Post-treatment arm volume reduced significantly after the Flexitouch system, but not after self-administered massage. The patients’ mean weight decreased significantly with Flexitouch use, but not with self-massage. The device was apparently well-tolerated and accepted by patients.
This short-term prospective evaluation of the Flexitouch system suggests the device may provide better maintenance edema control than self-administered massage in breast cancer-associated lymphedema.
Flexitouch – Interface Pressure Produced by Two Different Types of Lymphedema Therapy Devices
Author: Harvey N. Mayrovitz, PhD
Published: Physical Therapy. 2007; Vol. 87(10): 1379–1388
Sequential compression is used to manage lymphedema, but little is known about pressures delivered to the therapeutic targets. This study characterized actual pressures delivered by a traditional compression pump (Lympha Press) and one using an alternate compression pattern (Flexitouch).
Pressure patterns and magnitudes produced by the 2 devices differed considerably. The Flexitouch pressure pattern displayed rapid rise and fall, progressing from the wrist toward the elbow. The Lympha Press pressure rose slower and was sustained at a higher level during its inflation cycle. Pressures delivered with the Lympha Press were significantly greater than those delivered with the Flexitouch.
The pressure patterns and magnitudes on treated limbs depend on the device. These differences should be considered before selecting a device for a specific patient.
Flexitouch – Advanced Pneumatic Therapy in Self-Care of Chronic Lymphedema of the Trunk
Authors: Sheila H. Ridner, PhD, RN, Barbara Murphy, MD, Kie Deng, PhD, RN, Nancy Kidd, BS, Emily Galford, RN, and Mary S. Dietrich, PhD
Published: Lymphatic Research and Biology. 2010; Vol. 8(4): 209–215
The purpose of this study was to conduct a preliminary, post-market, home study of the Flexitouch system to examine the potential efficacy of the device as a component of self-care in breast cancer survivors with truncal lymphedema.
Logs revealed 100% compliance with the eight prescribed unobserved home treatments. Symptoms were assessed by self-report symptom surveys. Signs, objectively observed physical phenomenon, were assessed by staff-initiated skin examination and circumferential truncal measurements. Statistically significant improvement in truncal symptoms and sleep were found. Changes in function and girth were not statistically significant in this initial study.
Breast cancer survivors with truncal lymphedema may benefit from using an advanced pneumatic compression devices with truncal treatment as part of their self-care program. Participants were highly compliant in device use.
Flexitouch – Pneumatic Compression Devices for In-Home Management of Lymphedema: Two Case Reports
Author: Samantha Cannon, MSOT/L, CLT
Published: Cases Journal. 2009; Vol. 2:6625
The two patients in this case series had experienced long-term difficulty controlling lymphedema at home. Both patients had used numerous home therapies, including older-generation intermittent pneumatic compression devices, without success. The Flexitouch system, an advanced pneumatic device, was prescribed to assist them with in-home efforts by providing therapy to their affected limbs in addition to the lower trunk area for the patient with lymphedema of the lower extremity; and the trunk, chest, wall, and shoulder areas for the patient with lymphedema of the upper extremity. Both patients achieved successful home maintenance of lymphedema, as judged by limb volume, clinical observations, and subjective patient impressions, after incorporating the Flexitouch system. Neither patient experienced the deleterious effects (worsening genital edema, fibrotic cuff development) that they experienced with the older-generation intermittent pneumatic compression devices they had previously used. Incorporating the Flexitouch system as part of maintenance may improve success for lymphedema patients who have previously struggled with in-home management.
Flexitouch – Overcoming Barriers in the Management of Lower Extremity Lymphedema Utilizing Advanced Pneumatic Therapy
Authors: Tina Hammond, PTA, CLT-LANA, and Alison H. Golla, MA, OTR/L, CLT
Published: The Open Rehabilitation Journal. 2009; Vol. 2: 79–85
Lymphedema often requires intensive, costly treatment begun in the clinic and eventually self-administered by the patient at home. In-clinic complete decongestive therapy aims to reduce limb volume, improve mobility and reduce the risk of infection. Maintaining these clinical gains requires that a patient continues self-administered treatments at home. This case study follows a patient with primary bilateral lower extremity lymphedema from initial in-clinic therapy through her two year follow-up visit. Barriers to lymphedema management faced by this patient are identified, the clinical reasoning for the various treatment options tried is provided and the subsequent functional outcomes are presented. The case study suggests that the Flexitouch system offers promise as an adjunct to in-home treatment for patients whose lymphedema has proven challenging to control.
Flexitouch – Can Truncal Edema be Treated with Pneumatic Compression
Author: Tina Hammond, PTA, CLT-LANA
Published: National Lymphedema Network’s LymphLink. 2009; Vol. 21(2)
A 44-year-old female patient received complete decongestive therapy (CDT) with utilization of an advanced programmable pneumatic compression device (PCD) during in-clinic and home maintenance phases to treat her truncal and lower extremity lymphedema. For the past two years, the patient has continued to effectively control her lymphedema utilizing the advanced PCD with truncal appliance, in addition to exercise and daily garment wear. She modifies her treatment regime as needed with supplemental device programs used to target specific areas. These options are available using the programmable components of the PCD. She has required no additional in-clinic treatment for complications of lymphedema since initiating treatment with the advanced PCD.
Flexitouch – Programmable Intermittent Pneumatic Compression as a Component of Therapy for Breast Cancer Treatment-Related Truncal and Arm Lymphedema
Author: Tina Hammond, PTA, CLT-LANA, and Harvey N. Mayrovitz, PhD
Published: Health Care Management Practice. 2010; Vol. 22: 397–402
The physiological basis for truncal treatment, although clinically recognized, was not well documented until recently. This study expands on earlier work by reporting on clinical outcomes, therapist observations, and subjective impressions of five patients with truncal lymphedema whose in-home self-treatment includes the Flexitouch system. Results, after 2 months of treatment, showed reductions in trunk and arm swelling, fibrotic tissue softening, pain reduction, and improved range of motion and flexibility. Patients reported that the Flexitouch system was comfortable to use and enhanced in-home compliance. Results suggest that limb and trunk lymphedema can be effectively treated in the home with an advanced programmable pneumatic device with truncal treatment, such as the Flexitouch system.
Flexitouch – Reduction of Complications and Associated Costs with Flexitouch Therapy for Lymphedema
Author: Tina Hammond, PTA, CLT-LANA
Published: The Open Rehabilitation Journal. 2009; Vol. 2: 59–62
Lymphedema is a chronic condition requiring multiple clinic visits over several weeks for costly treatment and education by a trained therapist, followed by lifelong in-home self-care. The self-care regimen can be physically and psychologically demanding and inadequate treatment can lead to progression of the lymphedema and serious complications. The patient described in this report was diligent with a home care program yet experienced difficulty controlling her lymphedema independently, necessitating a return to skilled therapy for repeated treatments. This case study describes the impact that an advanced pneumatic device, the Flexitouch system, had on the costs of treatment and quality of life for a patient with lymphedema. Substantial long- and short-term cost reductions and quality-of-life gains may have been realized as the patient achieved successful maintenance of a home care program without any lymphedema-related complications or infections requiring hospitalization, antibiotic therapy, or in-clinic lymphedema therapy.
Flexitouch – Using a Programmable Pneumatic Device with Truncal Therapy to Facilitate Wound Healing: A Case Series
Author: Caren Betz, PT
Published: Ostomy Wound Management. 2009; Vol. 55(3): 34–40
A sequential intermittent pneumatic compression (IPC) device was evaluated in four patients with nonhealing wounds caused by venous insufficiency, postsurgical complication or radiation burns, and all had minimal to extensive clinically observable edema. All patients received standard wound care. Wounds were protected with an anti-shear wound dressing during pneumatic treatment. Each week, the various wounds and limb girths decreased until the site healed or limb volume normalized for that individual; 100% of the wounds healed. One patient, who had minimally observable edema, also responded positively when IPC was added to his standard wound care regimen. The pneumatic system was well tolerated in all patients. The results obtained suggest that combining appropriate standard wound care with this IPC treatment may facilitate closure of chronic, nonhealing wounds.
Flexitouch – Development of a Framework for Pneumatic Device Selection for Lymphedema Treatment: A Case Series Report
Author: Sonja M. Maul, CLT-LANA, Julie A. Devine, OTR/L, CLT, and Carolyn R. Wincer, PT, DPT, CLT-LANA
Published: Medical Devices: Evidence and Research. 2009; Vol. 2: 57–65
This paper tracks results of three patients with difficult to manage leg and trunk lymphedema. All were treated with the current standard of care, complete decongestive therapy, and all met obstacles in achieving independent self-care. The use of the Flexitouch and Lympha Press Optimal®, two different programmable pneumatic compression devices (PCDs), were investigated to determine if these devices could enable this type of patient to meet their discharge goals. Results indicate that programmable PCDs can be effective in managing complicated cases of leg and trunk lymphedema, and that clinical outcomes may differ between the devices. In this trial, the device with lower applied pressures and smaller pneumatic chambers proved easier for patients to tolerate and provided better patient outcomes. These cases show that in-home use of an appropriate PCD can help patients with stage 3 and advanced stage 02 lymphedema achieve stable limb volumes with no exacerbation of lymphedema related symptoms.
Venous Leg Ulcer Studies
Actitouch Delivers Accurately Targeted and More Consistent Compression versus Multi-Layer Bandages
Authors: Mayrovitz HN, Partsch H, Vanscheidt W
Published: Journal of Wound, Ostomy & Continence Nursing September/October 2015
To compare interface pressure profiles of Actitouch therapy with traditional 4LB and compare the ability of each to sustain graduated compression over time.
At 1 hour, the 4LB showed a significant (P < 0.001) decline in pressures while seated at all three pressure sites while Actitouch pressures showed no decline. By hour 8 of device wear, the largest average seated pressure decrease for the 4LB occurred at site 2 and was 9.1 mmHg, while Actitouch showed an increase of 4.9 mmHg at the same site.
Actitouch delivers a more consistent and predictable sustained interface pressure when compared to a 4LB. The 4LB demonstrated significant pressure loss.
Actitouch System Improves Quality of Life; High Adherence to Therapy and High Satisfaction in Patients with Venous Leg Ulcers
Authors: Keith G Harding, CBE FRCGP FRCP FRCS FLSW, Wolfgang Vanscheidt, MD, Hugo Partsch, MD, Joseph A Caprini, MD, & Anthony J Comerota, MD
Published: International Wound Journal May 2014
Efficacy, functionality, safety, patient perceptions and impact on QoL were evaluated for Actitouch adaptive compression therapy compared to a standard four-layer bandage (4-LB) (Profore™ Multi-Layer Bandaging System, Smith & Nephew Medical Wound Management, U.K.) for the treatment of patients with VLUs.
Healing time and rates were comparable between the two groups. Actitouch QoL index score was significantly higher than the index score for 4-LB with a statistically significant P value of 0.0375. Patients rated Actitouch significantly higher than 4-LBs for exudate management, skin protection, removal ease, bathing and sleep comfort; other performance ratings were comparable between the two groups. Adverse events were comparable in type and frequency with no serious adverse events in either group.
Actitouch is a safe and effective therapy that significantly improves patient QoL when compared with a traditional 4-LB. Given more control over their own therapy, patients are empowered to perform daily activities such as showering/bathing, and unencumbered sleep while engaging in an effective treatment regimen.
Dose-response of compression therapy for chronic venous edema — higher pressures are associated with greater volume reduction: Two randomized clinical studies
Authors: Wolfgang Vanscheidt, MD, Alexandra Ukat, MD, and Hugo Partsch, MD Published: Journal of Vascular Surgery, February 2009
Evaluate the safety and relative effects of different cuff pressure combinations to determine if edema reduction was dose-dependent.
A dose-response relationship was observed between increased SPC/IPC pressures and reduced limb edema. Limb volume was reduced most effectively with the highest pressures of 40-mm Hg nongraduated SPC and 60-mm Hg graduated IPC (136 mL and 87 mL, respectively); however, some subjects reported discomfort with these profiles. Limb volume was reduced by more than 100 mL with 30 to 40-mm Hg graduated SPC and by 69 mL with 50-mm Hg graduated IPC, and subjects rated these profiles as comfortable or very comfortable. Of the 28 study participants (12 SPC, 16 IPC), two subjects reported pain with 60-mm Hg IPC; no other adverse events were reported with SPC or IPC.
Pneumatic compression was safe and well-tolerated, with a dose-response relationship between increased SPC/IPC pressures and reduced leg edema. To our knowledge this is the first study to demonstrate a dose-relationship in compression therapy: higher pressures are associated with greater volume reduction in subjects with chronic venous edema.