IROS received the US Food and Drug Administration (FDA) 510(k) clearance to market its updated AIROS 6 Sequential Compression Device and related accessory garments
AIROS Medical, a medical technology manufacturer specializing in compression therapy products that treat cancer-related lymphedema and venous complications, today announced the launch of its updated AIROS 6 Sequential Compression Therapy device and Arm Plus garments following multiple regulatory approvals.
IROS 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,” says 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 4-7 million patients have lymphedema in the United States. Studies show that 34% of lymphedema cases are cancer-related, and 25% of those cases are caused by breast cancer. According to the National Cancer Institute, 45% 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.
Source: Company Press Release