A Medical Device Daily
Medical Acoustics (Buffalo, New York), a commercial-stage device company that employs acoustic technologies for diagnostic and therapeutic medical applications, reported that it has filed an application with the FDA for 510(k) clearance of its Therapeutic Lung Flute.
The application follows the recent successful completion of a clinical trial at the University at Buffalo and the Western New York VA Medical Center.
The clinical trial, led by principal investigator Sanjay Sethi, MD, was designed to demonstrate the safety and effectiveness of the Therapeutic Lung Flute. The Lung Flute met all primary and secondary endpoints among patients with chronic obstructive pulmonary disease (COPD) with chronic bronchitis.
This simple, hand-held, reusable therapeutic device supplements the patient's natural mucus-clearing system by introducing low frequency sound waves into the lungs. Respiratory illnesses such as COPD, tuberculosis, lung cancer, chronic bronchitis, community acquired pneumonia and asthma are on the rise and becoming an increasing burden on the healthcare system.
"According to the World Heath Organization, there are over 16 million Americans diagnosed with COPD and, it is the fourth-leading cause of death worldwide," said Terence Cryan, president of Medical Acoustics. "With this filing we have taken a significant step forward in bringing the Therapeutic Lung Flute to market in order to provide a medical device that better addresses the needs of this large and growing patient population than current technologies."
He added, "The results of our clinical trial suggest that the Lung Flute provides a safe, effective, low cost and patient friendly method for patients with COPD to maintain their respiratory health through regular use. The Lung Flute offers benefits to patients over the current market leading oscillatory positive expiratory pressure device and has the potential to make a lasting positive impact on the quality of life of millions of COPD sufferers."