Breathe Technologies has obtained the fifth 510(k) clearance from the US Food and Drug Administration (FDA) for its non-invasive open ventilation (NIOV) system, allowing its use with compressed air supply for non-oxygen dependent patients.
With the new FDA approval, the one-pound non-invasive mechanical ventilator can now be used to assist patients with neuromuscular diseases, such as amyotrophic lateral sclerosis and multiple sclerosis.
The latest approval also allows the use of the wearable ventilation system with compressed air in patients with non-oxygen dependent respiratory diseases such as scoliosis.
Previously, the Breathe NIOV system obtained four FDA approvals, allowing its use with compressed oxygen in homecare and institutional settings, and includes invasive and noninvasive patient circuits.
Breathe Technologies claims that the Breathe NIOV system, which utilizes novel venturi principle technology, is the first and only FDA-cleared ventilation system for people with respiratory insufficiency.
Providing augmented tidal volume and supplemental oxygen, the device reduces the work of breathing by unloading the ancillary respiratory muscles for people with respiratory insufficiency caused by chronic obstructive pulmonary disease, including Alpha-1 Antitrypsin deficiency.
Patients with pulmonary fibrosis, interstitial lung disease, cystic fibrosis and most respiratory conditions that result in activity-limiting shortness of breath may receive similar benefits with the device.
According to Breathe Technologies, data from the seven studies that support the efficacy of the Breathe NIOV System demonstrate that the device reduces dyspnea, increases oxygenation, enhances exercise endurance, and unloads respiratory muscle activity.
Breathe Technologies president and CEO Larry Mastrovich noted that with five distinct FDA clearances, the company has demonstrated that the 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," Mastrovich added.
Image: Breathe Technologies’ NIOV ventilator. Photo: Courtesy of PRNewswire/Breathe Technologies, Inc.