Abbott announced that the US Food and Drug Administration (FDA) approved the Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.
Xience V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's Taxus paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. Xience V will be launched in the United States immediately.
"Xience V represents an important treatment advance for the estimated 13 million people in the United States suffering from coronary artery disease, and we believe Xience V will quickly become the new standard for drug eluting stents given its outstanding clinical results," said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. "Physicians in the United States have been waiting for years to treat their patients with a technology that delivers on the promise of drug eluting stents through both ease of use and excellent clinical performance, and Xience V is that technology."
The Xience V drug coated stent is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. Coronary artery disease occurs when plaque build-up narrows the arteries and reduces blood flow to the heart, which can lead to chest pain or a heart attack.
"Xience V was designed to improve safety and efficacy compared to earlier generation stents. The long-term clinical data from two studies performed in both the United States and Europe have now confirmed that Xience V is a true next-generation drug eluting stent with clinically important benefits for patients," said Gregg W. Stone, M.D., Columbia University Medical Center; chairman, Cardiovascular Research Foundation, New York; and principal investigator of the Spirit III US pivotal clinical trial for Xience V.