Abbott (NYSE:ABT) said today that it won CE Mark approval in the European Union for its next-generation drug-eluting stent, the Xience Sierra.
The everolimus-eluting coronary stent is designed to allow cardiologists to treat the complex lesions that make up roughly 70% of cases, the Chicago-area healthcare giant said. It offers a thinner profile, increased flexibility, longer lengths and smaller diameters than previous stents.
“Doctors tell us they need better tools to treat increasingly challenging cases, which involve multiple, or totally blocked arteries and complications such as diabetes,” vascular SVP Chuck Brynelsen said in prepared remarks. “We designed Xience Sierra with the goal of helping more people with coronary artery disease regain their health and return to their daily lives as quickly as possible.”
“Xience Sierra can help cardiologists be even more precise when implanting the stent, which is important for efficacy and safety,” added vascular chief medical officer Dr. Charles Simonton. “Its design, range of sizes and increased flexibility mean doctors don’t have to use as much force when they implant a Xience Sierra stent compared to other stents.”
Abbott said it’s also applied for U.S. approval from the FDA for Xience Sierra.