Olympus Medical Systems, a provider of optical and digital solutions for medical and surgical procedures, has launched its FDA-approved Spiration Valve System (SVS) for the treatment of severe emphysema, a progressive form of Chronic Obstructive Pulmonary Disease (COPD).
Alternative to more invasive options like surgery, minimally invasive bronchoscopic lung volume reduction using endobronchial valves is being recommended for severe emphysema.
Spiration Valve is an umbrella shaped device, placed in targeted airways of the lung during a short bronchoscopic procedure. It improves breathing by redirecting air from diseased parts of the lungs to healthier parts, enabling healthier tissue to expand.
SVS therapy would result in volume reduction of the treated part of the lung, facilitating the healthier tissue in the remaining portion of the lung to function more effectively. This improves breathing and prevents patients from suffering breathlessness, fatigue and provides improved quality of life.
SVS was approved by the FDA on the basis of the EMPROVE clinical trial results. The results demonstrated that patients treated with the SVS benefited from statistical and clinical improvements in lung function and quality of life compared to standard of care medical management.
Dr. Gerard Criner, founding chair of the department of thoracic medicine and surgery at the Lewis Katz School of Medicine, Temple University, said: “The EMPROVE trial corroborates and substantiates other data that shows how important it is to recognize that hyperinflation has a negative outcome on patients’ physiologic function, their quality of life, and even their survival.
“By having a potent therapy that significantly reduces lung hyperinflation, and is durable over time, you can start to see patients making truly meaningful improvements and achieving clinical outcomes such as improvements in lung function and quality of life.”
SVS offered results showing a favorable risk benefit profile, with a short procedure time. Results from previous clinical studies have shown that shorter procedure times may reduce the risk of adverse events. Serious adverse events observed in the study include COPD exacerbations, pneumothorax, pneumonia and death.
The SVS is approved for use in the treatment of emphysema in the US, EU countries, Australia and New Zealand.