Westmed, Inc. Receives FDA Clearance For The Vibralung® Acoustical Percussor
TUSCON, Ariz., Aug. 19, 2014 /PRNewswire/ -- Westmed, Inc., a leader in the design, manufacture and marketing of medical devices used in respiratory therapy and anesthesia, announced today that the U.S. Food and Drug Administration (FDA) has granted it 510(k) clearance to market the company's 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. 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. 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.
Clinical studies for the Vibralung Acoustical Percussor were conducted at the University of Arizona Medical Center Tucson in conjunction with the physicians at the Cystic Fibrosis Center. Copies of the abstract presented at the NACF conference in October of 2013 in Salt Lake City are available upon request.
About Westmed, Inc.
Westmed is a vertically integrated medical device manufacturing company that develops, manufactures and markets both disposable and reusable respiratory and anesthesia medical devices. Established in 1992, Westmed has experienced consistent growth since its inception, by understanding and addressing the changing needs of the healthcare industry.
Contact
Jon McKinnon
Westmed, Inc.
jon@westmedinc.com
SOURCE Westmed, Inc.