Abbott (NYSE:ABT) announced today that the Xience stent family received FDA approval for one-month dual antiplatelet therapy (DAPT) labeling.
The FDA’s approval for one-month (as short as 28 days) DAPT labeling applies to high bleeding risk (HBR) patients in the U.S., according to a news release. The company also recently received CE mark approval in Europe for DAPT as short as 28 days, which it says gives Xience stents the shortest DAPT indication in the world.
In addition to the new indication for HBR patients, Abbott said it won FDA approval and CE mark for the next-generation Xience Skypoint stent, which it says is easier to place and allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively.
Xience Skypoint won approval for use in HBR patients with one-month DAPT labeling, with Abbott touting data from 120 clinical trials of 125,000 patients as proof of safety, effectiveness and successful patient outcomes.
“Even small differences between stents can impact both short- and long-term patient outcomes, and this latest generation of the Xience stent offers multiple improvements that provide enhanced deliverability and expansion capability,” Abbott CMO & divisional VP of global medical affairs Dr. Nick West said in the release. “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.”