The FDA has granted 510(k) clearance to Westmed Inc to market the Vibralung Acoustical Percussor. 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 company.
These conditions are typical in patients diagnosed with cystic fibrosis, chronic bronchitis, bronchiectasis, pneumonia, ciliary dyskinesia syndromes, asthma, muscular dystrophy, post-operative atelectasis plus neuromuscular respiratory impairments, thoracic bellows defects, and any other cardiorespiratory or neuromuscular diseases that inhibit effective cough, mucokinesis, airway clearance and expectoration.
Unlike any other alternative, the Vibralung Acoustical Percussor applies vibratory sound waves, during inspiration and exhalation, over a wide range of frequencies (5 to 1,200 Hz) to vibrate the column of gas in the tracheobronchial tract, Westmed explained. As a result, mucus is loosened and separated throughout the airways to promote safe, effective and gentle Airway Clearance Therapy (ACT).
According to the company, the Vibralung Acoustical Percussor can be used as either sole or adjunct therapy, depending upon the patient’s needs and response. It is lightweight, portable and battery-powered, so it can go almost anywhere the patient goes.
In addition, the Vibralung Acoustical Percussor also employs Positive Expiratory Pressure (PEP) that is applied simultaneously for its beneficial effects. Aerosol therapy with Westmed’s Circulaire II Hybrid high-efficiency aerosol drug delivery system can also be used to concomitantly deliver respiratory medications.
Because the Vibralung Acoustical Percussor does not make contact with the external chest wall, it is a gentler form of ACT than oscillatory PEP devices. 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 chest wall injuries, burns, fresh surgical wounds or injured/broken ribs.