Breathe Technologies, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the fifth 510(k) clearance for its Non-Invasive Open Ventilation (NIOV) System, allowing its use with compressed air supply for non-oxygen dependent patients. The previous four FDA clearances cover the use of the Breathe NIOV System with compressed oxygen for home and institutional use, and include invasive and noninvasive patient circuits.
The Breathe NIOV System is the first and only FDA-cleared, wearable, ventilation system for people with respiratory insufficiency. It provides augmented tidal volume and supplemental oxygen, which reduces the work of breathing for people with respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD), including Alpha-1 Antitrypsin Deficiency. Patients that may receive similar benefits include those with pulmonary fibrosis, interstitial lung disease, cystic fibrosis and most respiratory conditions that result in activity-limiting shortness of breath.
The new FDA clearance for use of the Breathe NIOV System with compressed air allows for the wearable ventilator to be used to assist patients with neuromuscular diseases, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. 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.
Over time, neuromuscular disorders can weaken the muscles that are essential for breathing, making it difficult for patients to move air in and out of the lungs effectively. Respiratory failure, often in association with an infection, is a frequent cause of death for people with neuromuscular diseases.
"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, Apple Valley, Minn.
The Breathe NIOV System reduces the work of breathing by unloading the ancillary respiratory muscles. Data from the seven studies that support the efficacy of the Breathe NIOV System demonstrate that the device reduces dyspnea (shortness of breath), increases oxygenation, enhances exercise endurance, and unloads respiratory muscle activity.
Data comparing the Breathe NIOV System to the Carefusion LTV were presented at the recent COPD8USA conference. Data were collected using a lung simulator, which can simulate normal and disease-related lung mechanics. The data demonstrated that NIOV breath delivery characteristics are comparable to both of these ventilators whether using compressed air or oxygen. The LTV was the predicate device for the original FDA 510(k) filing.
"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," said Larry Mastrovich, president and CEO of Breathe Technologies.
Breathe Technologies, Inc.