Breathe Technologies announced that the U.S. Food and Drug Administration (FDA) has granted 501(k) clearance for its Non-Invasive Open Ventilation (NIOV) System for use with compressed air supply.
The latest clearance is the fifth from the FDA and covers non-oxygen dependent patients with respiratory diseases such as scoliosis. Previous clearances covered the use of NIOV with compressed oxygen for home and institutional use, and include invasive and noninvasive patient circuits.
Larry Mastrovich, president and CEO of Breathe Technologies, said, “With five distinct FDA clearances, we have demonstrated that Breathe Technologies' NIOV System has broad applications to help patients with respiratory insufficiency diseases become more mobile and independent. Our newest clearance allows many patients with neuromuscular disorders to have access to our technology as well.”
The Breathe NIOV System is the first and currently the only FDA-cleared and wearable ventilation system for patients with respiratory insufficiency. NIOV provides augmented tidal volume and supplemental oxygen to reduce the labor of breathing for people affected with chronic obstructive pulmonary disease (COPD) and other respiratory diseases including Alpha-1 Antitrypsin Deficiency. Those who are afflicted with pulmonary fibrosis, interstitial lung disease, cystic fibrosis and other respiratory conditions may also benefit from the Breathe NIOV System.
The FDA clearance was supported by data presented at the recent COPD8USA conference, where the device demonstrated non-inferiority to Carefusion LTV ventilators whether using compressed air or oxygen.
“As neuromuscular diseases progress, patients may need augmented ventilatory support in order to breathe. The Breathe NIOV System offers a lightweight and wearable design that couples the efficacy of mechanical ventilation therapy with the benefits of mobility for spontaneously breathing patients whose muscle strength and overall mobility is compromised. It is also a welcome therapeutic addition for patients with non-oxygen dependent respiratory diseases," said Robert RRT, FAARC, General Manager of ValleyAire Respiratory Services, Apple Valley, Minnesota.