CENTER VALLEY, Pa., Dec. 5, 2018 /PRNewswire/ -- Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today FDA approval of its Spiration Valve System (SVS) for the treatment of severe emphysema, a progressive form of Chronic Obstructive Pulmonary Disease (COPD). In addition to being designated a breakthrough medical device, the SVS was granted priority review status by the FDA because it is intended to treat a life-threatening or irreversibly debilitating disease or condition and offers significant, clinically meaningful advantages over existing legally marketed alternatives.
FDA approval of the SVS is based on results of the EMPROVE clinical trial demonstrating that patients treated with the SVS benefited from statistically significant and clinically meaningful improvements in lung function and quality of life compared to standard of care medical management. Further, the results showed that the SVS offers a favorable risk benefit profile, with a short procedure time, which may reduce the risk of adverse events. Serious adverse events observed in the study include COPD exacerbations, air leak (pneumothorax), pneumonia and death.1
Placed in targeted airways of the lung during a short bronchoscopic procedure, the Spiration Valve is an umbrella shaped device that improves breathing by blocking airflow to the diseased portion of the lung. SVS therapy leads to volume reduction in the treated part of the lung, allowing the healthier tissue in the remaining portion of the lung to function better.1
"In the patients I treated in the EMPROVE trial, the most important outcome was a marked reduction in shortness of breath, or dyspnea," said Dr. Gerard Criner, MD, Professor and Founding Chair of the Department of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine, Temple University. "This resulted in improved quality of life and patient satisfaction. Dyspnea is the most common symptom in patients with advanced emphysema and severe hyperinflation, and is the most refractory to medical treatment."
According to the Centers for Disease Control and Prevention, COPD affects more than 15 million people, including the 3.5 million who have emphysema, and is the third leading cause of death in the U.S.2 The SVS is an important new therapy for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.
Prominent guidelines3,4 now recommend minimally invasive bronchoscopic lung volume reduction using endobronchial valves as an alternative treatment option for severe emphysema to more invasive options, such as open surgery.
The SVS is now approved for use in emphysema in the U.S., E.U., Australia and New Zealand.
Olympus offers a broad portfolio of respiratory devices and bronchoscopes that are instrumental in helping to improve efficiency and facilitating the delivery of quality patient care in the bronchoscopy suite.
Olympus is a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our nearly 100-year history, Olympus has focused on being true to society and making people's lives healthier, safer and more fulfilling.
Our Medical Business works with health care professionals to combine our innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing with their skills to deliver diagnostic, therapeutic and minimally invasive procedures to improve clinical outcomes, reduce overall costs and enhance quality of life for patients. For more information, visit medical.olympusamerica.com.
1 Spiration Valve System. 2018. Summary of Safety and Effectiveness. 2 Chronic Obstructive Pulmonary Disease: Basics About COPD, Centers for Disease Control. https://www.cdc.gov/dotw/copd/index.html, June 5, 2018 3 2019 Global Strategy for the Diagnosis, Management, and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2018. http://goldcopd.org 4 National Institute for Health Care and Excellence. 2017. Endobronchial valve insertion to reduce lung volume in emphysema; Interventional procedures guidance [IPG600]. https://www.nice.org.uk/guidance/ipg600