Tactile Medical Launches Next-Generation Nimbl Pneumatic Compression Platform for Lymphedema

October 11, 2024—Tactile Systems Technology, Inc. (Tactile Medical) recently announced that Nimbl, its next-generation pneumatic compression platform, is now commercially available in the United States for the treatment of upper extremity lymphedema. The company also recently announced the publication of a prospective, clinical trial that assessed outcomes associated with use of the company’s Flexitouch advanced pneumatic compression device in veterans with lower extremity lymphedema.

According to Tactile Medical, the Nimbl platform is indicated as a treatment option for patients with both upper and lower extremity lymphedema, chronic edema, venous insufficiency, and wound healing. The company expects to make Nimbl commercially available for patients with lower extremity conditions in the coming months.

Nimbl received FDA 510(k) clearance in June 2024. In September, it received Pricing, Data Analysis, and Coding approval from the Centers for Medicare & Medicaid Services.

Tactile Medical noted that Nimbl is 68% lighter, 40% smaller, and uses 33% less hosing than the company’s current generation basic pneumatic compression device. Nimbl also offers connectivity to the company’s free Kylee digital application, providing patients a simple way to track their usage and change in symptoms, and to share results with their care team.

In the prospective, longitudinal, pragmatic study of the Flexitouch device, 179 veterans were enrolled at four participating Veterans Affairs medical centers. Chronic venous insufficiency was the most common etiology of lymphedema (phlebolymphedema), presenting in approximately 63% of study patients. Mild lymphedema was the most common disease stage, presenting in 68% of patients.

The findings were published by Frank T. Padberg, Jr., MD, et al in the Journal of Vascular Surgery, Venous and Lymphatic Disorders.

The company stated that 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.

According to Tactile Medical, the study demonstrated significant improvements in its primary endpoint of health-related and general QoL measures. Specifically, lymphedema QoL increased from 6.2 to 6.9, which included improvements in function, appearance, symptoms, and emotion.

The secondary endpoint results demonstrated several statistically significant improvements from baseline to 52 weeks. These included reduction in limb girth of 1.4 cm; decrease of cellulitis events from 21.4% to 6.1%; and decrease of skin hyperpigmentation from 75% of patients to 40%.

Additionally, improvements in compliance and limb girth reduction 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; and 6% limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema, reported the company.