AIROS Medical has received the US Food and Drug Administration (FDA) 510(k) approval for its AIROS 8P sequential compression therapy device and garment system.
The new AIROS 8P is an extension to the company’s FDA-approved AIROS 8 device.
It offers pneumatic compression therapy to both the upper and lower body, along with the trunk, for the treatment and management of lymphedema, CVI, and other venous disorders.
The upgraded version comes with a third primary operating mode, the Peristaltic Mode, for use with AIROS’ Arm and Arm plus garments.
It can also be used with pants garments for the treatment of swelling in the legs and lower truncal areas of the body, including the abdomen.
In addition, AIROS 8P features a larger air pump and upgraded 100-240 VAC electrical capabilities, which enables international usage, said the medical technology company.
AIROS Medical CEO and president Gerald Makoid said: “AIROS Medical is one of the fastest-growing pneumatic compression therapy device manufacturers in the world.
“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.”
AIROS said that the FDA approval allows providing larger compression therapy garments, including lower truncal garments to treat abdominal swelling.
The truncal garment is designed in a pants-like configuration, used for the treatment of patients with lymphedema in the lower legs, back, abdomen, pelvic, and hip areas.
Lymphedema is a chronic condition where damaged or removed lymph nodes result in the accumulation of fluids, which leads to swelling in various areas of the body.
Chronic venous insufficiency (CVI) is a venous disorder caused by improper functioning of vein valves in the legs, preventing blood flow back to the heart.
