AUDUBON, PA — AIROS® Medical, Inc. has launched its U.S. Food and Drug Administration 510(k)-cleared ARTAIRA® Arterial Compression Device, a prescription-only system designed to increase blood flow in patients suffering from certain symptoms of peripheral arterial disease.
The non-invasive intermittent pneumatic compression device is engineered to improve circulation in the lower extremities — including the legs, ankles, and feet — allowing patients to undergo treatment at home.
Peripheral arterial disease, or PAD, is a progressive vascular condition in which narrowed arteries restrict blood flow to the limbs. The disease can cause severe leg pain, non-healing ulcers, infections and, in advanced cases, tissue death and amputation. According to the American Limb Preservation Society, a 2025 global study projects a 220% increase in PAD cases worldwide by 2050, reaching more than 360 million people.
ARTAIRA delivers rapid, high-pressure compression cycles to the calf, ankle and foot. The system inflates and deflates two-chamber garments worn on the legs, delivering 120mmHg of pressure in a timed sequence designed to stimulate circulation and improve blood flow to the lower limbs.
“Millions of aging Americans, including many diabetics, experience pain in their legs, have trouble healing foot ulcers, and are at risk of other serious health complications including amputation as a result of poor blood flow to the lower extremities. ARTAIRA increases circulation to treat these conditions and help patients return to regular activities and lifestyles,” said Darren M. Behuniak, Chief Operating Officer of AIROS Medical, Inc. “Our company has focused on treating patients with lymphedema and chronic venous insufficiency and we are thrilled to apply our user-friendly pneumatic compression technology to this adjacent patient population with vascular disorders. We view ARTAIRA as a natural progression of our product line and look forward to enhancing the quality of life for even more patients in the United States and abroad.”
The seven-pound device features a large color LCD screen that displays pressure settings and treatment times, and operates through a simplified two-button interface designed for home use.
AIROS Medical said ARTAIRA is now available nationwide and is reimbursed by Medicare and certain commercial insurers when proper documentation is provided. The company plans to support the rollout through clinical education programs, professional workshops and live demonstrations at podiatric, vascular and wound care conferences.
As PAD diagnoses continue to climb, the company positions ARTAIRA as a tool aimed at addressing a growing public health challenge — one that experts warn could surge dramatically in the coming decades.
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