Airway Clearing Device Gets FDA Clearance

Batesville, Ind.-based Hill-Rom Holdings Inc. was granted 510(k) clearance from the U.S. Food and Drug Administration for its Metaneb 4.0 system, an airway clearing technology for enhanced patient hospital care. The system delivers therapy through airway oscillation (continuous high frequency oscillation) and continuous pressure (continuous positive expiratory pressure). According to the company, the system helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung.

When used with compressed oxygen, the system can also provide supplemental oxygen, Hill-Rom claims.

“The design enhancements to the Metaneb System represent another great example of Hill-Rom’s dedication to improving outcomes for patients and their caregivers,” said Greg Pritchard, senior vice president, surgical and respiratory care, for Hill-Rom. “Together with the Vest airway clearance system, our Respiratory Care portfolio now offers complementary innovative solutions for patients with respiratory disorders.”

Metaneb is indicated for use in patients with bronchiolitis, cystic fibrosis, asthma, chronic bronchitis, neuromuscular disorders, emphysema, chronic obstructive pulmonary disease, patients needing post-operative airway management, patients needing emergency room airway management, among others. Hill-Rom plans to begin shipping the system in June.

Hill-Rom makes patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products, and information technology solutions.