Abbott Receives U.S. FDA Approval for XIENCE Sierra Heart Stent

Abbott Laboratories announced it has received U.S. Food and Drug Administration (FDA) approval for its XIENCE Sierra stent, expanding treatment options for patients with complex coronary artery blockages. The stent is designed for use in percutaneous coronary intervention (PCI), a minimally invasive procedure to open blocked arteries.

The XIENCE Sierra stent is engineered to enhance deliverability and precise placement in challenging anatomical configurations, such as long or calcified lesions, or when multiple stents are required. These conditions represent a significant portion of PCI procedures.

"We developed XIENCE Sierra so that physicians can more easily deliver the stent even in challenging cases," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision, while having confidence in the outcomes and safety they expect from XIENCE."

The XIENCE Sierra stent previously received regulatory approval in Europe in 2017 and has since obtained regulatory approval and reimbursement in Japan. Abbott also provides diagnostic and imaging tools to assist interventional cardiologists in complex PCI procedures.