Abbott Gains European Approval for Drug-Eluting Stent

Abbott Laboratories, a medical device company located in Abbott Park just outside Chicago, Ill., has received the CE mark for its Xience Xpedition 48 Everolimus-eluting coronary stent system. The system is designed to treat very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD). Xience Xpedition 48 joins the Xience family of drug-eluting stents, and is the only one with a 48 mm length. Drug-eluting stents greater than 38 mm in length are not very common, and Abbott claims it was the first company to offer physicians size-specific metallic stents for use in small and large vessels of the heart.

Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation. The drug is typically used as an immunosuppressant in patients with organ transplants.

Studies indicate that physicians choose to use multiple shorter length stents to meet the challenges of treating long blockages or lesions in as many as 30 percent of interventional heart procedures, as conventional stent sizes may not always fully cover the lesion, according to a 2010 Journal of the American College of Cardiology article. It has also been shown, however, that the use of a single stent instead of multiple stents may result in several procedural benefits, including the use of fewer devices, less exposure to X-ray during the procedure, and reduced procedure time, which could lead to economic benefits. This data was presented in a 2002 article in the Journal.

In patients with coronary artery disease, lesions are caused by the buildup of fat and cholesterol inside blood vessels; long lesions are most often seen in patients with diabetes, who are a significant and growing portion of the population due to changing diet and lifestyle habits (Heart 2004). When the blood vessels feeding the heart are blocked or partially blocked due to CAD, patients can experience symptoms such as chest pain and shortness of breath, and in some cases, a heart attack.

“With global economic pressures impacting hospitals and health care systems around the world, products like Xience Xpedition 48 may provide important cost savings to the system,” said Peter Smits, M.D., of Maasstad Ziekenhuis in Rotterdam, the Netherlands. “I believe that this new treatment option, backed by the robust clinical outcomes of the Xience family of drug-eluting stents, will help physicians in the treatment of long lesions.”

Abbott is using data from previous clinical trials conducted with the Xience family of drug-eluting stents as proof of efficacy for its new stent.

“One of the hallmarks of Abbott’s vascular product development is our ability to identify new ways to help physicians address the needs of their patients,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president of medical affairs and chief medical officer at Abbott Vascular. “Xience Xpedition 48 provides a new, unique solution for treating patients with very long lesions, affirming Abbott’s commitment to continued innovation.”

Xience Xpedition is available in diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and now with lengths ranging from 8 mm to 48 mm.

Abbott Vascular, a division of Abbott Laboratories, focuses on cardiac and vascular care, particularly drug-eluting stents.