Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device.
The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during a bronchoscopic procedure to reduce lung volume in diseased lung sections and allow healthier tissue in the remaining portion of the lung to function better.
Approval of the device came based on the results from the Emprove clinical trial of the SVS, which demonstrated that patients treated with the system showed statistically significant and clinically meaningful improvements in lung function and quality of life as compared to the standard of care.
Results also indicated a favorable risk benefit profile and a shortened procedure time, which Olympus said may reduce the risk of adverse events. Serious adverse events noted in the study included chronic obstructive pulmonary disorder exacerbations, air leaks, pneumonia and death.
“In the patients I treated in the Emprove trial, the most important outcome was a marked reduction in shortness of breath, or dyspnea. 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,” Dr. Gerard Criner of the Lewis Katz School of Medicine at Temple University said in a press release.
In October, Olympus said that it launched the Endoeye Flex 3D and FlexDex needle driver laparoscopic surgical tools in the U.S.
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