AIROS 8 Sequential Compression Therapy Device Granted FDA 510(k) Clearance

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The AIROS 8 Sequential Compression Therapy device and garment system have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The news was announced today by AIROS® Medical, Inc.

According to various estimates from non-profit organizations, private companies, research studies, and government entities, approximately 4-7 million patients have lymphedema in the United States. Lymphedema is a chronic condition in which damaged or removed lymph nodes creates fluid build-up and swelling most common in the arms, legs, chest, back, and torso. Many patients develop lymphedema after undergoing cancer-related treatments such as radiation and chemotherapy. Post-mastectomy breast cancer patients are among those at the highest risk of developing lymphedema.

The AIROS 8 Sequential Compression Therapy device uses pneumatic air compression to inflate accessory garments worn on the affected area of the body. The inflation and deflation sequences, delivered at the pressure and time prescribed by a physician or lymphedema therapist, move the lymphatic fluid in the correct physiological direction. AIROS Medical has sold the AIROS 8 and its garments since August 2018, but this new FDA 510(k) clearance allows the company to treat breast cancer patients with lymphedema more effectively.

“We are thrilled to launch our revamped AIROS 8 device and Arm Plus upper extremity product line as it will allow us to expand the number of patients we can help live more comfortably,” says Gerald Makoid, CEO and president of AIROS® Medical. “Our team of clinical partners, engineers, and medical device veterans, along with our customers in the durable medical equipment industry, have served the lymphedema community for nearly two decades. We are ecstatic to grow our product offerings and collaborative efforts with healthcare providers to help improve the quality of life for patients living with this chronic condition, lymphedema.”

The AIROS 8 is also available for use with leg garments and arm garments. The leg garments are utilized primarily with patients who have venous complications, including chronic venous insufficiency (CVI), which affects nearly 16 million Americans.

AIROS Medical also manufactures the AIROS 6 device and garment system, which operates in a similar fashion as the AIROS 8. The AIROS 6 model is primarily utilized by patients with Medicare insurance.

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