Positive Results Reported With Advanced Pneumatic Compression Device Therapy

Tactile Systems Technology Inc.’s Flexitouch advanced pneumatic compression device (APCD) can help improve limb girth and skin hyperpigmentatiion, according to new study results.

Published in the Journal of Vascular Surgery, Venous and Lymphatic Disorders, the trial assessed outcomes associated with use of the company’s Flexitouch APCD in veterans with lower extremity lymphedema. The 52-week study represents the largest peer-reviewed, prospective, clinical trial investigating PCDs and lymphedema ever published in the United States.
 
The prospective, longitudinal, pragmatic study publication, “Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema”, was authored by Padberg et al. and included 179 Veterans across four participating VA medical centers. The primary outcome measures included disease-specific health-related quality of life (QoL) endpoints obtained at baseline and again at each of 12, 24, and 52 weeks. The secondary outcome measures assessed limb circumference, cellulitis events, skin quality, and therapy compliance over the course of 52 weeks. Among the patients included in the study, chronic venous insufficiency was the most common etiology of lymphedema (phlebolymphedema), presenting in approximately 63% of study participants. Further, mild lymphedema was the most common disease stage, presenting in 68% of patients.
 
The secondary endpoint results demonstrated several statistically significant improvements, baseline to 52 weeks, with reductions in limb girth, cellulitis events, and skin hyperpigmentation. Among these results, the following were observed:

• Limb girth decreased by 1.4 cm
• Cellulitis events decreased from 21.4% to 6.1%
• Skin hyperpigmentation decreased from 75% of patients to 40%  

There were additional improvements also noted in compliance and limb girth reduction which included:

• A 92% patient compliance rate (defined as used for five to seven days per week) with Flexitouch at eight weeks and 72% patient compliance at 52 weeks
• A 74% patient compliance rate with compression garments at 52 weeks, compared to 64% at baseline
• Six percent limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema 

“We sincerely thank the clinical researchers, patients, and VA Medical Centers for advancing peer-reviewed evidence that supports clinical and patient benefits of our Flexitouch therapy,” Tactile Medical President/CEO Sheri Dodd stated. “Achieving these study results, including compliance over a one-year timeframe, validates the importance of APCD therapy outcomes and demonstrates a patient experience that supports strong adherence to therapy. We are proud to provide Veterans the at-home tools they need to improve their clinical symptoms and quality of life.”
 
Tactile Medical develops and markets at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease. Tactile Medical collaborates with clinicians to expand clinical evidence, raise awareness, increase access to care, reduce overall healthcare costs and improve the quality of life for tens of thousands of patients annually.