Medical devices firm Olympus has launched the new Spiration Valve System (SVS) in the US for the treatment of severe emphysema, a type of chronic obstructive pulmonary disease (COPD).
The endobronchial valve is an umbrella shaped device that can be placed in targeted airways of the lung. It is designed to redirect air from diseased parts to healthier parts, in turn improving breathing.
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Olympus said that treatment with the new device may cause volume reduction in the treated part and enable the healthier tissue in the remaining part of the lung to work more effectively.
The Spiration Valve can be used to help adults suffering from shortness of breath and hyperinflation due to severe emphysema in the lung regions with evidence of low collateral ventilation.
Olympus America Endoscopy division group vice-president Kurt Heine said: “We are very excited to add the Spiration Valve System to our broad portfolio of respiratory devices and bronchoscopes.
“The SVS provides physicians a minimally invasive option for treating severe emphysema, allowing patients to find relief from debilitating symptoms.”
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By GlobalDataSVS secured approval from the US Food and Drug Administration (FDA), which reviewed findings from the EMPROVE clinical trial performed in patients with severe emphysema.
Patients treated with the device were observed to experience statistically significant and clinically meaningful improvements in lung function and quality of life, when compared to standard of care.
In addition, the device is said to offer a favourable risk benefit profile and a short procedure time.
Serious adverse events observed during the EMPROVE trial include COPD exacerbations, pneumothorax, pneumonia and death.
Besides the US, Spiration Valve is approved in the European Union (EU) markets, Australia and New Zealand for the treatment of emphysema.
