The Japan's Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for Abbott's Xience Sierra, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent.
XIENCE Sierra improves upon previous versions of XIENCE with an enhanced stent design, a new delivery system, and unique sizes to help doctors treat challenging cases.
XIENCE Sierra was designed to help doctors more easily treat people with difficult-to-treat blockages that involve multiple or totally blocked arteries or complications such as diabetes.
Complex cases are increasingly prevalent as people with coronary artery disease are living longer.
Abbott's vascular business senior vice president Chuck Brynelsen said: "Extensive clinical data and 10 years of real-world experience with the XIENCE family of stents provide doctors with confidence that they are treating their patients with one of the safest stents available.
"National reimbursement of XIENCE Sierra will provide people in Japan with greater access to this life-changing technology that can help them live their best lives."
Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan. National reimbursement in Japan will enable doctors to treat more patients with XIENCE Sierra through the country's health insurance plans.
XIENCE Sierra was approved in Japan on April 4, 2018, received CE Mark in Europe late last year, and is under review with the U.S. Food and Drug Administration.
XIENCE has been studied in over 100 clinical trials and in 10 years of global real-world experience. Its safety profile is unprecedented with consistent low rates of stent thrombosis, even in complex cases. More than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.
XIENCE first received CE Mark in 2006 and FDA approval in 2008. A special coating on XIENCE interacts with proteins in the blood to reduce the risk for blood clots in the stent.
Source: Company Press Release