Abbott Straight To Market With Newly FDA Approved Xpedition™ Drug Stent

“XIENCE Xpedition represents a powerful 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”

In short

Abbott’s XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has received U.S. FDA approval and is to be  launched immediately in the United States.

Abbott’s two big claims for its XIENCE drug eluting stents is that they come in a the widest range of sizes and also are the only drug eluters to be approved for direct stenting.

Background

Abbott’s XIENCE stents, of which Xpedition is one, remain the only drug eluting stents in the U.S. market to be indicated for direct stenting (stent insertion without lesion preparation using another device such as a balloon). This single step operation clearly has the potential to save time and resources in the catheterization laboratory if it can be proven safe and effective, to which end XIENCE Xpedition is supported by robust clinical evidence from the XIENCE stent family. Clinical support comes from data on over 45,000 patients across more than 100 studies, with long-term outcomes out to five years. Abbott says the data have consistently shown an excellent safety profile for the XIENCE family of stents.

XIENCE Xpedition will be available in the largest size matrix in the U.S. market, with both rapid exchange (RX) and over-the-wire (OTW) configurations, providing physicians with the most popular delivery platforms. XIENCE Xpedition has diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 mm to 38 mm, for more accurate vessel sizing.

Physician comments

“XIENCE Xpedition represents a powerful 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 Dr. Samin Sharma MD, from Mount Sinai Medical Center, New York, and the first physician to implant a patient with XIENCE Xpedition in the United States.. “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.”

Company comments

“The launch of XIENCE Xpedition in the United States will advance Abbott’s worldwide market-leading position in drug eluting stents,” said John M. Capek, Ph.D., executive vice president, Medical Devices, 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.”

Regulatory status

With the new U.S. approval, XIENCE Xpedition is now available in the United States, Europe, the Middle East and parts of Asia. XIENCE PRIME® and XIENCE V® are available in countries throughout the world.

Source: Abbott Vascular