The U.S. Food and Drug Administration (FDA) expanded the approved use of the CoreValve self-expanding transcatheter aortic valve replacement (TAVR) system to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one. This is the first transcatheter heart valve approved in the United States for valve-in-valve procedures in both high and extreme risk patients who have limited options or may otherwise go untreated.
The Medicines Company announced that the European Commission has granted marketing authorization for two acute care products – Kengrexal (cangrelor) and Raplixa (sealant powder). These approvals follow the issuance of positive opinions in January by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
A team of investigators at Children’s Hospital Los Angeles and the University of Southern California have developed the first fully implantable micropacemaker designed for use in a fetus with complete heart block. The team has done preclinical testing and optimization as reported in a recent issue of the journal Heart Rhythm.
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AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved a new administration option for acute coronary syndrome (ACS) patients who are unable to swallow ticagrelor (Brilinta) 90 mg tablets whole. Unlike other P2Y12 inhibitors, ticagrelor has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.
