FDA Approves Abbott Drug Eluting Stent System The U.S. Food and Drug Administration has granted Abb

FDA Approves Abbott Drug Eluting Stent System
The U.S. Food and Drug Administration has granted Abbott Laboratories pre-market approval for its next-generation Xience Xpedition drug eluting stent system. The company plans to launch the product in the United States immediately. Xience Xpedition is intended to optimize drug deliverability, particularly in challenging coronary anatomies, and reportedly has the largest size range of any drug eluting system currently on the market.

“Xience Xpedition represents a combination of deliverability, strong clinical data and broad availability of meaningful sizes—three factors that make this product well-suited to treat a wide range of patients,” said Samin K. Sharma, M.D., director of clinical and interventional cardiology, dean of international clinical affiliations, and president of the Mount Sinai Heart Network at Mount Sinai Medical Center in New York, N.Y. Sharma was the first doctor to implant the Xience Xpedition in an American patient. “The impact of the changes to the stent delivery system is particularly notable in patients with complex coronary anatomy. For these patients, physicians have a new technology to reach the blockage and restore blood flow with ease and confidence.”

Abbott claims its Xience line of drug eluting stents—including the Xpedition—are the first and only drug eluting stents in the U.S. market that have proven to be safe for direct stenting. Direct stenting, a technique in which the stent system is not preceded by another device (such as a balloon dilatation catheter) to prepare the lesion, has the potential to save time and resources in the catheterization laboratory. The Xience Xpedition is supported by clinical evidence from the Xience family of drug eluting stents, including data from more than 45,000 patients in more than 100 studies, with long-term outcomes of up to five years.

“The launch of Xience Xpedition in the United States will advance Abbott’s worldwide position in drug eluting stents,” said John M. Capek, Ph.D., executive vice president of medical devices at Abbott. “Xience Xpedition leverages the strong clinical outcomes of Xience V and Xience Prime while providing important advantages in deliverability. With its redesigned stent delivery system and a full matrix of sizes, Xience Xpedition provides physicians with a comprehensive, trusted option to treat a broad range of patients with coronary artery disease.”

In the United States, Xience Xpedition will be available with both rapid exchange and over-the-wire configurations, which are the most popular delivery platforms. Xience Xpedition has diameters ranging from 2.25 millimeters to 4 millimeters, including a special 3.25-millimeter diameter, and lengths from 8 millimeters to 38 millimeters, for more accurate vessel sizing.

Abbott Vascular, a division of Abbott, will market the devices. Based in Abbott Park, Ill., Abbott produces healthcare devices for various medical applications. Abbott Vascular’s portfolio includes products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.