AIROS received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its updated AIROS 6 Sequential Compression Device and related accessory garments, including the Arm Plus garment that can be prescribed by a physician to treat lymphedema in the arm, shoulder, chest, and back.
The company also announced that the Pricing, Data, Analysis, and Coding (PDAC) contractor for Center for Medicare & Medicaid Services (CMS) has approved Healthcare Common Procedure Coding System (HCPCS) codes for the AIROS 6 device and related accessory garments, including the Arm Plus garment.
“We are excited to launch our advanced AIROS 6 device system as it will provide a new treatment option for breast cancer patients battling lymphedema, including those who utilize Medicare,” said Gerald Makoid, CEO and president of AIROS Medical. “Our research showed that older patients with these types of health complications were underserved. We set out to develop high-end compression therapy technology that was easy for elderly patients to use to drive high compliance and produce better outcomes. We are thrilled to add these products to our line and continue our mission to help lymphedema patients live more comfortably.”
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, and back. Many patients develop lymphedema after undergoing cancer-related treatments such as radiation and chemotherapy.
According to various estimates from non-profit organizations, private companies, research studies, and government entities, approximately 4 million to 7 million patients have lymphedema in the United States. Studies show that 34 percent of lymphedema cases are cancer-related, and 25 percent of those cases are caused by breast cancer. According to the National Cancer Institute, 45 percent of female breast cancer patients are over the age of 65.
The AIROS 6 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. Use of compression therapy has proven to reduce pain and swelling and increase mobility for patients.
The company’s product line includes the AIROS 6 and AIROS 8 Sequential Compression Devices and various compression garments that provide therapy to the legs, arms, shoulders, chest, and back.