US’ Airos Medical receives FDA clearance to market therapy device

Airos Medical, a medical technology manufacturer and designer specialising in compression therapy devices that treat lymphedema and venous complications, has announced it has received the US Food and Drug Administration (FDA) 510(k) clearance to market its Airos 8P Sequential Compression Therapy device and garment system.

The clearance also allows Airos to provide larger compression therapy garments including lower truncal garments to treat abdominal swelling.

Various estimates indicate that 5-10 million Americans or more have lymphedema, a chronic condition in which damaged or removed lymph nodes creates fluid build-up and swelling in various areas of the body. Millions more suffer from chronic venous insufficiency (CVI), a venous disorder in which vein valves in the legs do not function properly preventing or limiting blood flow back to the heart, the company said in a press release.

The Airos 8P pneumatic compression device and new truncal garment line will allow Airos Medical to treat more of these patients. The truncal garment is designed in a pants-like configuration, which is ideal for patients with lymphedema in the lower legs, back, abdomen, pelvic, and hip areas. The device, an extension of the company’s Airos 8 model that has provided treatment for patients since 2018, also adds Peristaltic Mode functionality for upper body treatment. This operating mode is sometimes preferred by physicians and lymphedema therapists due to its wave-like inflation and deflation sequences that relieve pressure in the upper extremities for some patients who need this functionality.

“Airos Medical is one of the fastest-growing pneumatic compression therapy device manufacturers in the world,” said Gerald Makoid, CEO and president of Airos Medical. “Physicians and lymphedema therapists across the country rely on our device line every day to treat upper extremity lymphedema as well as CVI and lymphedema in the legs. The addition of our truncal garment line, as well as the new Peristaltic mode in the 8P device, will help even more patients who are largely immobile live better. In keeping with our overall approach to medical device design, these products incorporate the technology physicians and lymphedema therapists require with easy-to-use features to drive patient compliance. We are thrilled to now be able to treat lymphedema in nearly all areas of the body.”

The Airos 8P also features a larger air pump and upgraded 100-240 VAC electrical capabilities, allowing the device to be used anywhere in the world. This paves the way for Airos’ future international expansion as many countries in Europe, Asia, and elsewhere use higher electrical voltages.


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