CE Mark For World’s Longest Coronary Drug Eluting Stent

Abbott has announced CE Mark for its the XIENCE Xpedition™ 48 Everolimus Eluting Coronary Stent System, the first-of-its-kind treatment for very long blockages in the coronary vessels. XIENCE Xpedition 48 leverages the proven design and clinical outcomes of the XIENCE family of drug eluting stents in a unique 48 mm length.

Background

The XIENCE family of drug eluting stents delivers everolimus, an anti-proliferative drug used in Abbott’s XIENCE coronary stent systems. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.

Physicians choose to use multiple shorter length stents to meet the challenges of treating long lesions in as many as 30 percent of interventional heart procedures, as conventional stent sizes may not always fully cover the lesion. The availability of a single stent option may result in several procedural benefits, not least economic, by using fewer devices, with less exposure to X-ray during the procedure, and reduced procedure time.

XIENCE Xpedition is available in one of the broadest size matrices on the European market. With 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 can claim it offers physicians more options for the treatment of patients with complex coronary artery disease. Indeed the company is the only major manufacturer to offer a coronary drug eluting stent greater than 38 mm in length.

Physician comments

“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., Maasstad Ziekenhuis, 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.”

Company comments

“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, Medical Affairs and chief medical officer, Abbott Vascular. “XIENCE Xpedition 48 provides a new, unique solution for treating patients with very long lesions, affirming Abbott’s commitment to continued innovation.”

Regulatory status

In the United States, XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions =28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.

 

Source: Abbott Vascular, PR Newswire