Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve for cardiac treatment which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new patient population afflicted with dysfunctional right ventricular outflow tract conduit or a dysfunctional bioprosthetic valve in the pulmonic position. With a 4.3% dysfunction rate, the Sapien 3 is cleared to go on the market after having begun the clinical trial process in 2016.
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