Largest U.S. Prospective Clinical Trial Ever Conducted Demonstrated High Compliance with the Flexitouch? System and Significant Improvements Across Study Endpoints

MINNEAPOLIS, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced the publication of a new clinical study in the Journal of Vascular Surgery, Venous and Lymphatic Disorders. This study assessed outcomes associated with use of the Company’s Flexitouch advanced pneumatic compression device (APCD) in Veterans with lower extremity lymphedema. Notably, this 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, titled “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 study demonstrated significant improvements in its primary endpoint of health-related and general quality of life measures. Specifically, Lymphedema Quality of Life (QoL) increased from 6.2 to 6.9, which includes improvements in function, appearance, symptoms, and emotion.

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:

• 92% patient compliance (defined as used for 5 to 7 days per week) with Flexitouch at 8 weeks and 72% patient compliance at 52 weeks

• 74% patient compliance with compression garments at 52 weeks, compared to 64% at baseline

• 6% limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema.