AIROS Medical launches FDA-cleared home compression device for peripheral arterial disease

AIROS Medical Inc., a medical technology company specializing in compression therapy systems, has launched a U.S. Food and Drug Administration 510(k)-cleared device designed to improve blood flow in patients with peripheral arterial disease, the company announced.

The prescription-only ARTAIRA Arterial Compression Device is a noninvasive, intermittent pneumatic compression system intended for home use. It delivers high-pressure compression to the calf, ankle and foot to increase circulation in the lower extremities for patients experiencing some symptoms of PAD, a condition caused by narrowed arteries that restrict blood flow to the limbs.

PAD is a growing global health concern. A 2025 global study cited by the American Limb Preservation Society projects a 220% increase in PAD cases worldwide by 2050, reaching more than 360 million people. The disease can cause leg pain, slow-healing wounds, infections and, in severe cases, amputation.

“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,” said Darren M. Behuniak, chief operating officer of AIROS Medical. “ARTAIRA increases circulation to treat these conditions and help patients return to regular activities and lifestyles.”

The device uses air compression and tubing to inflate two-chamber garments worn on the legs, delivering 120 millimeters of mercury of pressure in a timed sequence. One chamber inflates behind the calf, while the other inflates under the foot. The seven-pound system features a two-button interface and a color LCD screen displaying pressure and treatment time.

ARTAIRA is now available throughout the United States and is reimbursed by Medicare and some commercial insurers with appropriate documentation, the company said.

Advances in compression therapy and PAD treatment expand home-based care

The launch of ARTAIRA comes amid broader advances in the treatment of peripheral arterial disease, particularly in technologies that aim to improve circulation while allowing patients to manage care outside of clinical settings.

Historically, PAD treatment has focused on lifestyle modification, pharmacologic therapy, supervised exercise programs and, in more advanced cases, surgical or endovascular interventions such as angioplasty or stenting. While these approaches remain central to care, interest has grown in adjunctive therapies that can improve blood flow and symptom relief for patients who are not candidates for invasive procedures or who need ongoing support between clinical visits.

Intermittent pneumatic compression has gained attention as one such option. Newer devices have evolved beyond simple calf compression, incorporating multi-chamber designs that target the foot and ankle to better mimic physiologic blood flow patterns. Improvements in pressure control, treatment sequencing and ease of use have made these systems more feasible for home-based therapy, particularly for older adults and patients with diabetes.

At the same time, advances in digital displays, simplified controls and lighter-weight hardware are reducing barriers to adherence. Clinicians increasingly cite usability as a key factor in whether patients consistently follow prescribed compression regimens, especially when treatment is conducted without direct supervision.

The broader PAD care landscape is also seeing progress in wound care integration, with compression therapy being paired more closely with ulcer management strategies to reduce the risk of infection and limb loss. In parallel, professional societies have emphasized earlier diagnosis and more aggressive management of PAD to prevent disease progression.

As health care systems continue to push care into lower-cost, home-based settings, technologies that support circulation, symptom management and quality of life are expected to play a growing role in PAD treatment strategies, particularly for the aging U.S. population.