Xience Skypoint has received FDA approval, the CE mark, and PMDA approval in Japan for the broadest expansion with the availability of extended sizes of 4.5 mm and 5 mm offerings.
According to Abbott, Xience Skypoint stents are now the only drug-eluting stents (DES) approved in the U.S. that improve access to care, enabling physicians to deliver advanced technology to patients with larger blood vessels. The expanded sizes are high bleeding risk (HBR)-indicated and represent the only DES with both one-month and three-month dual antiplatelet therapy (DAPT) labeling.
“I’m happy to see the expansion of the Xience Skypoint size matrix to now accommodate large vessels,” Mount Sinai Queens and Mount Sinai Hospital physician Dr. George Dangas said, according to Abbott. “This was a mid-lesion in a left coronary artery of a 48-year-old male patient. The 5.0×28 delivered like a 2.5 would have and I was happy with how it accommodated the vessel tapering, with our ability to follow up post dilatation of 5.5 proximally. Good addition to the Xience family.”
Xience Skypoint received FDA approval and CE marking in July 2021. It is described by Abbott as easier to place while allowing physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively.
Following FDA approval for one-month DAPT labeling using the Xience family of stents, Abbott CMO and Divisional VP of Global Medical Affairs for its vascular business Dr. Nick West, told Drug Delivery Business News that the latest iteration of the Xience platform offers a level of treatment that’s second to none.
“The Xience drug-eluting stent platform is probably the class-leading, best-in-class drug-eluting stent,” West said. “It has an unrivaled quantity and quality of data behind it. Compared to any other platform — and I’m not just saying this as a promotional thing — we have an unrivaled quantity of data. More than that, we have up to the minute data.”
