Medical device company Westmed has received 510(k) approval from the US Food and Drug Administration (FDA) for its Vibralung Acoustical Percussor.
The approval will allow the company to market the device, which was designed to use by patients with respiratory diseases and related conditions, which involve increased mucus production, infection and inspissation of secretions and defective mucociliary clearance.
These conditions can be seen 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 cardiorespiratory or neuromuscular diseases.
The Vibralung Acoustical Percussor enforces 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.
Due to this effect, mucus will get loosened and separated throughout the airways to promote safe, effective and gentle Airway Clearance Therapy (ACT).
Westmed noted that the device can be used as either sole or adjunct therapy, depending upon the patient’s needs and response.
The device also employs Positive Expiratory Pressure (PEP), which is applied simultaneously for its beneficial effects.
Westmed has conducted clinical studies for the Vibralung Acoustical Percussor at the University of Arizona Medical Center Tucson in conjunction with the physicians at the Cystic Fibrosis Center.
The results have been presented at the NACF conference in Salt Lake City in October 2013.