FDA clears Westmed to market airway clearance device

Westmed has received FDA 510(k) marketing clearance for its airway clearance device for use by patients with asthma and other respiratory diseases, according to a press release.

The Vibralung Acoustical Percussor was cleared for marketing in May, and Westmed is conducting final production process validation. It expects to fulfill orders and begin shipments in early September, a company spokesman said.

“The device is intended for use by patients with respiratory diseases and related conditions that involve increased mucus production, infection and inspissation of secretions, and defective mucociliary clearance,” according to the release.

Potential patients include those with asthma, cystic fibrosis, chronic bronchitis, bronchiectasis, pneumonia, ciliary dyskinesia syndromes, muscular dystrophy, postoperative atelectasis plus neuromuscular respiratory impairments, and thoracic bellows defects, the release said.

The Vibralung Acoustical Percussor, which is portable and can be used as sole or adjunct therapy, applies vibratory sound waves during inspiration and exhalation with a frequency range of 5 Hz to 1,200 Hz. It vibrates the column of gas in the tracheobronchial tract, loosening and separating mucus, according to the release.

“Because the Vibralung Acoustical Percussor does not make contact with the external chest wall, it is a gentler form of ACT [airway clearance therapy] than oscillatory PEP [positive expiratory pressure] devices,” the release said. “It may be especially useful for airway clearance therapy when other means like vests and hand-held chest percussors cannot be used, such as with patients that have injuries, burns, fresh surgical wounds or injured/broken ribs.”

Clinical study results for the device were presented at the North American Cystic Fibrosis Conference in 2013, according to the release.