(Reuters) - The U.S. Food and Drug Administration on Friday approved Pulmonx Inc’s valve to treat a severe form of obstructive lung disease, most often characterized by shortness of breath.
Treatment for severe emphysema, which damages air sacs in the lungs and limits patients’ breathing ability, is currently limited to capsules and inhalers.
Pulmonx's Zephyr endobronchial valve is intended to treat breathing difficulty associated with severe emphysema, the agency said (for a link, click bit.ly/2tGQU0L).
About 3.5 million American adults have been diagnosed with emphysema, an advanced form of Chronic Obstructive Pulmonary Disease (COPD), according to Centers for Disease Control and Prevention.
“The (current) treatments work to some extent for the earlier stages of the disease,” said Beran Rose, Pulmonx’s vice president for business development and marketing. “At the other end of the spectrum is invasive treatments.”
The lung valve, Rose said, would fill this wide gap in treatment methods available in market.
The tiny, cylindrical valve is permanently implanted using a catheter in the affected part of a patient’s lung and regulates the airflow to the healthier parts.
On average, patients may need four valves and depending upon the severity of emphysema, the cost of treatment could go up to $10,000 per patient.
The valves are already in use in Europe and some parts of Asia and the company, Rose said, is planning to launch the device in specialized clinical centers in the United States later this year.
Reporting by Anuron Kumar Mitra and Sharnya G in Bengaluru; Editing by Maju Samuel