FDA approves Xience Sierra everolimus-eluting coronary stent system.- Abbott.

Abbott announced it received approval from the FDA for the Xience Sierra, the newest generation of the company's gold-standard Xience everolimus-eluting coronary stent system. Xience stents are among the world's most-used and studied stents and have an exceptional safety record with low rates of complications. Design and technology advances in this generation of Xience include features specifically designed for the treatment of complex blockages that now account for up to 70 percent of cases.

The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents. Design innovations in Xience Sierra include a thinner profile, increased flexibility, longer lengths, and small diameters. The new stent and delivery system were specifically developed for the treatment of complex cases, including people with multiple or totally blocked vessels. More than 8 million people worldwide have received a Xience stent since its initial regulatory approvals in the EU in 2006 and in the U.S. in 2008.

Its safety record is supported in over 100 clinical trials and by 10 years of global real-world experience. Abbott received Regulatory approval for Xience Sierra in Japan in April 2018, and CE Mark in Europe in October 2017.

The Xience Sierra stent is implanted using a catheter that is inserted through the femoral artery in the groin or radial artery in the wrist.