Search results
Results from the WOW.Com Content Network
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug ...
A third trial, Study 402, aims to test lumateperone in addition to lithium or valproate, [11] [12] the data pertaining this trial is due out in 2020. [ 13 ] [ 12 ] Study 401 was conducted solely in the United States while Study 404 was a global study and included patients from the US.
The advisers voted 12-2 in favor of the effectiveness and unanimously backed safety of the device, which is similar to Abbott's older device MitraClip that operates in the upper and lower left ...
The Abbott device, TriClip, aims to treat tricuspid regurgitation (TR), which occurs when the valve separating the right lower chamber of the heart from the right upper does not close properly ...
St Jude Medical's Portico Transcatheter aortic valve received European CE mark approval in December 2013. The valve is repositionable before release to ensure accurate placement helping to improve patient outcomes. [12] Edwards' Sapien aortic valve is made from bovine pericardial tissue and is implanted via a catheter-based delivery system. It ...
In December 2020, after an additional clinical trial was completed, and FDA approval was expanded for 177 other cystic fibrosis mutations. [32] FDA approval for children aged 6–11 was added in January 2021, after a third clinical trial was completed. [33] In 2023, approval was extended to children 2–5. [34]
In 2013, the FDA lifted its earlier restrictions on rosiglitazone after reviewing the results of a 2009 trial which failed to show increased heart attack risk. [ 8 ] [ 9 ] In Europe, the European Medicines Agency (EMA) recommended in September 2010 that the drug be suspended because the benefits no longer outweighed the risks.
In 2021, FDA restricted use of Ocaliva to PBC patients who did not have advanced cirrhosis or severe scarring of the liver. US FDA staff questions confirmatory trial data for Intercept's liver ...