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Abbott receives CE Mark for newest generation of drug-eluting XIENCE coronary stent system

Abbott receives CE Mark for newest generation of drug-eluting XIENCE coronary stent system

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Abbott today announced it received CE Mark for XIENCE Sierra, the newest generation of the company’s gold-standard XIENCE everolimus-eluting coronary stent system. CE Mark allows sale of the device in the European Union and other countries that recognize CE Mark. Advances in this generation of XIENCE — which is known for its exceptional safety — include new features that make it easier for cardiologists to successfully complete complex procedures that now account for up to 70 percent of cases.

“Doctors tell us they need better tools to treat increasingly challenging cases, which involve multiple, or totally blocked arteries and complications such as diabetes,” said Chuck Brynelsen, senior vice president of Abbott’s vascular business. “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 makes it easier for cardiologists to access and unblock difficult-to-reach lesions. New features include a thinner profile, increased flexibility, longer lengths, and small-diameters.

“XIENCE Sierra can help cardiologists be even more precise when implanting the stent, which is important for efficacy and safety,” said Charles Simonton, M.D., chief medical officer of Abbott’s vascular business. “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.”

More than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.4 It is the most commonly used stent in Europe and has been studied in over 100 clinical trials and in 10 years of global real-world experience.

Abbott has also submitted an application to the U.S. Food and Drug Administration for XIENCE Sierra approval in the United States.

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