Tactile Medical Receives PDAC Approval for Lymphedema Platform

MINNEAPOLIS—Tactile Systems Technology Inc., a medical technology company providing therapies for people with chronic disorders, has been approved by the pricing, data analysis and coding (PDAC) contractor for the Centers for Medicare & Medicaid Services (CMS) for the use of health care common procedure coding system (HCPCS) code E0651 for billing the durable medical equipment Medicare administrative contractors for its pneumatic compression platform, “Nimbl.”

This PDAC approval follows the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) in June. Additionally, the company plans to make Nimbl commercially available across the United States in the coming weeks.

Nimbl is a basic lymphedema compression solution indicated for the treatment of lymphedema, chronic edema, venous insufficiency and wound healing. The device features several patient-friendly enhancements, including a 40% reduction in size and a 68% reduction in weight, making it portable and beneficial for active lifestyles. Users of Nimbl have access to the company’s “Kylee” digital application, which aims to let patients 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.”