The announcement came a month after FDA approval of Spiration, which was designated as a breakthrough medical device. Spiration also has regulatory approval in the E.U., Australia and New Zealand.
Olympus officials are touting standards from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the National Institute for Health Care and Excellence that recommend minimally invasive endobronchial valves for severe emphysema treatment, versus more invasive surgical options.
The Spiration valve is an umbrella-shaped device that a health provider places in a targeted airway of the lung during a short bronchoscopic procedure. The Spiration device is meant to improve breathing by redirecting air from diseased parts of the lungs to healthier parts. The air redirection enables healthier lung tissue to expand and function more effectively.
The improved breathing results in improved quality of life for the emphysema sufferer.
“The SVS offers significant benefit to a certain subpopulation of patients with emphysema,” said Dr. Kirk Voelker, interventional pulmonologist and director of clinical research at Sarasota Memorial Hospital.
“There were a low number of complications, such as pneumothorax and pneumonia, which are all easily treated, but, importantly, we saw the durable effects of the therapy lasting through the follow-up year with significant improvement in quality of life,” Voelker said in a news release.