Abbott's Xience Xpedition DES System Approved and Launched in US

January 3, 2013—Abbott Vascular (Santa Clara, CA) announced that its Xience Xpedition everolimus-eluting coronary stent system received US Food and Drug Administration approval. The device is being launched immediately in the United States. The Xience Xpedition is indicated for treating coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm.

According to the company's press release, the Xience Xpedition features a new stent delivery system designed to optimize deliverability, particularly in challenging coronary anatomies. The device is available in a large size matrix, with both rapid exchange and over-the-wire configurations. Diameters range from 2.25 to 4 mm, including a 3.25-mm diameter, and lengths from 8 to 38 mm for more accurate vessel sizing.

Samin K. Sharma, MD, was the first physician to implant the Xience Xpedition in a patient in the United States. Dr. Sharma, who is 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 City, commented on the device in the company's press release.

“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,” stated Dr. Sharma. “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 noted that its Xience drug-eluting stents, including the Xience Xpedition, have been proven safe for direct stenting, which has the potential to save time and resources in the catheterization laboratory. Additionally, the Xience Xpedition is supported by clinical evidence regarding the Xience family of drug-eluting stents that includes data from more than 45,000 patients from more than 100 studies with long-term outcomes out to 5 years.