Next-Generation System Significantly Reduces Device Size and Weight and Enables Integration with Kylee™ Digital App
MINNEAPOLIS, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) ( TCMD), a medical technology company providing therapies for people with chronic disorders, today announced that the Pricing, Data Analysis, and Coding (PDAC) contractor for the Centers for Medicare & Medicaid Services (CMS) has approved the use of Healthcare Common Procedure Coding System (HCPCS) code E0651 for billing the Durable Medical Equipment Medicare Administrative Contractors for Nimbl™, the Company’s next-generation pneumatic compression platform. PDAC approval is subsequent to the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in June 2024. The Company will make Nimbl commercially available in the United States in the coming weeks.
Nimbl is the next generation of the Company’s basic lymphedema compression solution and is indicated for the treatment of lymphedema, chronic edema, venous insufficiency, and wound healing. The device features several key patient-friendly enhancements over prior generations, including a 40% and 68% reduction in size and weight, respectively, making it more portable and ideal for active lifestyles. Nimbl offers connectivity to the Company’s Kylee™ digital application, enabling patients to actively track their therapy progress and share results with their care team.
“The receipt of PDAC approval for Nimbl comes earlier than expected, and we are pleased that CMS recognizes the potential health and quality-of-life enhancing benefits this device offers for Medicare patients struggling with lymphedema and chronic venous insufficiency,” said Sheri Dodd, Chief Executive Officer at Tactile Medical. “Nimbl’s new sleeker design and technical advancements reflect our commitment to meaningful product innovation that seeks to meet the patient wherever they are in the treatment pathway. I am proud of the work our team has accomplished in developing this new platform, which I believe will elevate lymphedema therapy and increase patient acceptance and adherence. We look forward to Nimbl’s upcoming full commercial launch in the weeks ahead.”
About Tactile Systems Technology, Inc. (DBA Tactile Medical)
Tactile Medical is a leader in developing and marketing at-home therapies for people suffering from underserved, chronic conditions including lymphedema, lipedema, chronic venous insufficiency and chronic pulmonary disease by helping them live better and care for themselves at home. 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 each year.
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