Non-Invasive Open Ventilation System approved

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Non-Invasive Open Ventilation System approved
Non-Invasive Open Ventilation System approved

Breathe Technologies, which makes the Non-Invasive Open Ventilation (NIOV) System, said the Food and Drug Administration has granted the fifth 510(k) clearance for the product.

The previous FDA clearances covered the NIOV with compressed oxygen for home and institutional use, and include invasive and noninvasive patient circuits. The new clearance also allows for the use of the Breathe NIOV System with compressed air in patients with non-oxygen dependent respiratory diseases such as scoliosis.

The Breathe NIOV System is the only FDA-cleared, wearable, ventilation system for people with respiratory insufficiency. It gives augmented tidal volume and supplemental oxygen, which reduces the work of breathing for people with respiratory insufficiency caused by chronic obstructive pulmonary disease. Those with pulmonary fibrosis, interstitial lung disease, cystic fibrosis and most respiratory conditions that result in activity-limiting shortness of breath also may benefit. It weighs one pound and has a comfortable facial interface.

"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 McCoy, RRT, FAARC, general manager, ValleyAire Respiratory Services, of Apple Valley, MN.