Tactile Medical has announced that Nimbl, its next-generation pneumatic compression platform, is now commercially available throughout the USA for the treatment of upper-extremity lymphoedema.
Nimbl, which the company notes is significantly smaller and lighter than previous device iterations, is indicated as a treatment option for patients with both upper- and lower-extremity lymphoedema, chronic oedema, venous insufficiency, and wound healing.
Tactile Medical details that Nimbl received US Food and Drug Administration (FDA) 510(k) clearance in June 2024 and Pricing, Data Analysis, and Coding (PDAC) approval from the Centers for Medicare & Medicaid Services (CMS) in September 2024. The company expects to make Nimbl commercially available for patients with lower extremity conditions in the coming months.
“We are excited to announce the commercial launch of Nimbl, an important addition to our leading portfolio of patient-focused, clinically proven lymphoedema therapy solutions,” said Sheri Dodd, chief executive officer at Tactile Medical, in a press release. “This first phase of Nimbl’s introduction, targeted specifically for upper extremity treatment, is well-timed as we recognise Breast Cancer Awareness Month and the many thousands of patients in need of better treatment solutions. Up to 40% of breast cancer survivors are affected by lifelong, debilitating lymphoedema symptoms through swelling and discomfort in the breast, trunk, arms, and hands, and we are proud to provide a highly effective and convenient treatment option. We look forward to expanding Nimbl’s launch to include patients with lower extremity conditions, and we remain committed to advancing solutions that increase patient access to therapy with a differentiated user experience.”
Tactile Medical claims that Nimbl is 68% lighter, 40% smaller, and uses 33% less hosing than the company’s current generation basic pneumatic compression device (PCD). A press release adds that the device’s compact design is the smallest PCD of its kind, making it an ideal therapy for daily use at home or on the go.
In addition to the patient centric feature enhancements, Tactile Medical shares that 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. Convenient accessories are available for purchase including a rechargeable battery and custom-designed travel bag.
“Patients and clinicians alike will appreciate the introduction of Nimbl as a compelling treatment option designed to increase adherence and improve clinical outcomes”, said Tony Gasparis, chief medical officer at Tactile Medical. “Patients can now more easily fit therapy into their daily routine resulting in long-term relief and increased confidence for clinicians.”
