June 30, 2021 – Abbott (Abott Park, IL) announced its XIENCE family of stents has received U.S. Food and Drug Administration (FDA) approval for one-month DAPT (as short as 28 days) labeling for high bleeding risk (HBR) patients in the U.S.
XIENCE stents recently received CE Mark approval for DAPT as short as 28 days – giving XIENCE stents the shortest DAPT indication in the world.
In addition to the HBR indication, Abbott has also received FDA approval and European CE Mark approval for its next-generation XIENCE Skypoint stent. XIENCE Skypoint is easier to place and allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively.
Patients who receive stents are typically on DAPT regimens (aspirin and P2Y12 inhibitors) for six to 12 months to prevent blood clots from blocking the stented vessel.
HBR patients can experience side effects such as bleeding during prolonged courses of DAPT.
With the shortest approved DAPT labeling, Abbott’s XIENCE stents can help physicians treat their HBR patients more effectively, the company says.
Abbott’s XIENCE 28 and XIENCE 904 studies show that DAPT can be safely discontinued early as short as 28 days with no increased risk in patient adverse events, solidifying the industry-leading safety profile of the XIENCE family of stents.