Abbott Announces CE Mark and European Launch of Next-Generation Xience Xpedition Drug-Eluting Stent
August 20, 2012 — Abbott today announced that the Xience Xpedition everolimus-eluting coronary stent system received CE mark in Europe for the treatment of coronary artery disease (CAD), and the company will immediately launch the product in CE-mark countries.
Xience Xpedition features a new stent delivery system designed to optimize acute performance, particularly in challenging coronary anatomies. It is supported by the clinical evidence of the Xience family of stents, including data from more than 45,000 patients across more than 100 studies with long-term outcomes out to five years. Xience Xpedition is available with a broad range of indications, including use with a minimum duration of three months of dual anti-platelet therapy (DAPT).
"The extraordinary deliverability of the new Xience Xpedition drug-eluting stent system allows physicians to treat particularly complex coronary disease with great ease and confidence," said Evald H. Christiansen, M.D., Ph.D., interventional cardiologist, Aarhus University Hospital, Skejby, Denmark, who treated the first patient with Xience Xpedition. "Supported by robust clinical evidence from the SPIRIT family of trials, and with a broad range of indications, Xience Xpedition is an important advancement in drug-eluting stent technology."
The Xience family of stents maintains one of the broadest ranges of CE mark indications of drug-eluting stents on the market in Europe. Specifically, Xience Xpedition has indications to treat patients with complex disease such as diabetes, as well as an indication for a minimum duration of three months of DAPT. This indication represents an important advantage, as three months of DAPT is the shortest duration required for any major drug-eluting stent offered in Europe. Long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events. In addition, having a shorter DAPT duration after stent implantation may be beneficial in case a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations.
"With Xience Xpedition's excellent deliverability, broad size matrix and the option to discontinue or interrupt DAPT after three months, physicians in Europe now have a new, comprehensive offering to address the challenges of treating patients with complex coronary artery disease," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer of Abbott Vascular. "With Xience Xpedition, Abbott continues its commitment to advancing drug-eluting stent technology to improve product performance and patient outcomes."
The stent is available in one of the broadest size matrices on the European market, with diameters ranging from 2.25 to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 to 38 mm.
For more information: www.abbott.com
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