Abbott gains key DAPT approvals for Xience stents in US, Europe
Abbott announced Wednesday, June 30, that its full line of Xience stents has received FDA approval for one-month dual anti-platelet therapy (DAPT) when treating high-risk patients.
This is the shortest DAPT indication approved in the United States, the company said in a prepared statement.
“The new FDA approval for DAPT for the Xience family of stents provides interventional cardiologists confidence they are delivering the best care to patients with high bleeding risk,” said Roxana Mehran, MD, a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City and the global principal investigator for Abbott’s short DAPT program. “A short DAPT duration minimizes risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance.”
In addition, Abbott’s Xience Skypoint stent is now approved as a treatment option for patients at a high risk of bleeding with one-month DAPT labeling in both the United States and Europe. The DAPT regimen can be as short as 28 days.
“As we continue to innovate at Abbott, we are delivering medical technology that improves patients' lives, while building a body of research evidence that underlines clinical consistency and patient safety,” Nick West, MD, chief medical officer of Abbott’s vascular business, said in the same statement.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.