Abbott Laboratories is taking one huge step forward with its drug-eluting stent offerings. The Abbott Park, IL-based company said it has won CE mark approval for dual anti-platelet therapy for as short as 28 days.
FDA also approved the firm’s Xience stent to be used for one-month dual anti-platelet therapy for patients at high bleeding risk.
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.
"The new FDA approval for DAPT for the Xiencefamily of stents provides interventional cardiologists confidence they are delivering the best care to patients with high bleeding risk. A short DAPT duration minimizes risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance," says Roxana Mehran, M.D., professor of medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai and the global principal investigator for Abbott's Short DAPT program (Xience 28 and Xience 90).
Xience is supported by the largest body of DAPT patient evidence, with more than 24,000 patients analyzed.
"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," said Nick West, MD, chief medical officer and divisional vice president of global medical affairs at Abbott's vascular business. "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."