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CE Mark Approval for Abbott's 48mm XIENCE Xpedition: World's Longest Drug-Eluting Stent
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XIENCE Xpedition Everolimus-Eluting Stent
XIENCE Xpedition Everolimus-Eluting Stent
May 26, 2013 -- Abbott (NYSE: ABT) announced this week that it has gained European CE Mark approval for its 48mm XIENCE Xpedition everolimus-eluting coronary stent, making it the longest coronary stent currently available. (Note: the 48mm Xpedition is not yet approved for use in the United States.)

Prior to this approval, the longest drug-eluting stent (DES) was 38mm, available from several manufacturers. Most recently Medtronic's Resolute Integrity was approved by the FDA for lengths of 34mm and 38mm for use in the United States.

Advantages to Long Length Stents
When a coronary blockage is stented, it is important for the stented area to be slightly longer than the diseased portion of the artery; otherwise the end of the stent is implanted in diseased plaque which puts the artery at risk for "edge-restenosis" or reblocking. When the disease spans a longer segment than the longest available stent, cardiologists usually overlap two stents to provide sufficient coverage. Historically, this has not been an optimal solution, because overlapping in the first generation of drug-eluting stents was shown to be an independent risk factor for restenosis. However, with the newer generation of drug-eluting stents, the technique of overlapping has been shown to be safe and effective, with no increase in restenosis.

However, being able to place a single stent makes the procedure quicker, which saves money. Using a single stent also requires less fluoroscopy time, thus less radiation. Additionally, longer blockages are more common in diabetic patients, so the 48mm stent may have increased utility for those cases. (It should be noted that in the U.S. only one stent has a specific labelled indication for diabetic patients: the Resolute Integrity, manufactured by Medtronic.)

The approval of a 48mm stent is not an insignificant development for interventional coronary devices. Not long ago, the concept of placing a stent almost 2 inches long inside the coronary artery was unimaginable -- today the European regulatory agency says "safe and effective."

A press release from Abbott follows:

Abbott Announces CE Mark for World's Longest Coronary Drug Eluting Stent

  • XIENCE Xpedition™ 48 Leverages Proven Design and Clinical Outcomes of the XIENCE Family of Drug Eluting Stents
  • Has the Potential to Reduce Overall Procedural Costs
  • Very Long Lesions Most Often Seen in Patients with Diabetes

May 21, 2013 -- Abbott Park, Illinois -- Abbott today announced CE Mark in Europe for the XIENCE Xpedition™ 48 Everolimus Eluting Coronary Stent System, the first-of-its-kind treatment for very long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD). XIENCE Xpedition 48 leverages the proven design and clinical outcomes of the XIENCE family of drug eluting stents in a unique 48 mm length. Abbott continues to offer physicians more options for the treatment of patients with complex coronary artery disease and is the only major manufacturer to offer a coronary drug eluting stent greater than 38 mm in length. XIENCE Xpedition 48 is the latest in a long history of stent innovations pioneered by Abbott, which was the first company to offer physicians size-specific metallic stents for use in small and large vessels of the heart.

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.[1] It has 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.[2]

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, a significant and growing portion of the population due to changing diet and lifestyle habits.[3] 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., 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."

XIENCE Xpedition 48 is supported by strong clinical evidence from the XIENCE family of drug eluting stents, including data from more than 53,000 patients across more than 100 studies with long-term outcomes out to five years. The safety of the XIENCE family of drug eluting stents has been consistently demonstrated in a number of clinical trials representative of routine clinical practice. The XIENCE family has one of the broadest ranges of CE Mark indications for drug eluting stents on the market in Europe, including indications to treat patients with complex disease such as diabetes.

"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."

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.

About the XIENCE Family of Drug Eluting Stents
In the United States, the XIENCE Xpedition and XIENCE PRIME stent systems, including XIENCE PRIME LL, are indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions = 32 mm) with reference vessel diameters of = 2.25 mm to = 4.25 mm. Additional information about XIENCE Xpedition and XIENCE PRIME, including important safety information, is available at or and

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. Additional information about XIENCE V, including important safety information, is available at

The XIENCE family of drug eluting stents delivers everolimus, an anti-proliferative drug used in Abbott's XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.

About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.

About Abbott
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.

Visit Abbott at and connect with us on Twitter at @AbbottNews.

Reported by Burt Cohen, May 26, 2013