Sam Brusco, Associate Editor04.04.23
AIROS Medical, a manufacturer of compression therapy devices to treat lymphedema and venous complications, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its AIROS 8P sequential therapy device and garment system.
The clearance also lets AIROS offer larger compression therapy garments, including lower truncal garments for abdominal swelling.
Lymphedema is a chronic condition where damaged or removed lymph nodes create fluid buildup and swelling in various areas of the body. Chronic vein insufficiency (CVI) is a venous disorder where vein valves in the legs don’t function properly and prevent or limit blood back to the heart.
The truncal garment is designed in a pants-like configuration, ideal for patients with lymphedema in the lower legs, back, abdomen, pelvic, and hip areas. The device is an extension of the company’s AIROS 8 model released in 2018 and adds a Peristaltic Mode functionality for upper body treatment.
“AIROS Medical is one of the fastest-growing pneumatic compression therapy device manufacturers in the world,” Gerald Makoid, CEO and president of AIROS Medical told the press. “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 prepares AIROS for future international expansion as many countries in Europe, Asia, and elsewhere use higher electrical voltages.
The clearance also lets AIROS offer larger compression therapy garments, including lower truncal garments for abdominal swelling.
Lymphedema is a chronic condition where damaged or removed lymph nodes create fluid buildup and swelling in various areas of the body. Chronic vein insufficiency (CVI) is a venous disorder where vein valves in the legs don’t function properly and prevent or limit blood back to the heart.
The truncal garment is designed in a pants-like configuration, ideal for patients with lymphedema in the lower legs, back, abdomen, pelvic, and hip areas. The device is an extension of the company’s AIROS 8 model released in 2018 and adds a Peristaltic Mode functionality for upper body treatment.
“AIROS Medical is one of the fastest-growing pneumatic compression therapy device manufacturers in the world,” Gerald Makoid, CEO and president of AIROS Medical told the press. “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 prepares AIROS for future international expansion as many countries in Europe, Asia, and elsewhere use higher electrical voltages.