FDA Regulatory Clearances for AIROS 8 Device and Garments Paves Way for Upper Extremity Post-Mastectomy Breast Cancer Treatment
Audubon, PA – January 13, 2020 – AIROS® Medical, Inc., a medical technology manufacturer specializing in compression therapy devices that treat cancer-related lymphedema and venous complications, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its updated AIROS 8 Sequential Compression Therapy device and garment system.
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 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.
About AIROS Medical, Inc.
AIROS® Medical, Inc. is a medical technology manufacturer, designer, and specification developer specializing in compression therapy. The company’s team of engineers, regulatory experts, and clinical partners create medical devices that improve quality of life for patients battling lymphatic and venous disorders, including the AIROS 6 and AIROS 8 Sequential Compression Devices. AIROS Medical was founded in 2016 and is headquartered in Audubon, PA.