Abbott Announces CE Mark and European Launch of Next-Generation XIENCE Xpedition™ Drug Eluting Stent
New Drug Eluting Stent System is Designed to Offer Enhanced Deliverability with the Proven Clinical Outcomes of XIENCE V® and XIENCE PRIME®
Approval Includes Expanded CE Mark Indications to Treat Patients with Complex Disease and a Minimum Duration of Three Months of Dual Anti-Platelet Therapy
Offers One of the Broadest Size Matrices in the European Market, Including a Unique 3.25 mm Diameter for More Accurate Vessel Sizing
August 20, 2012
Abbott Park, Illinois (NYSE: ABT) — Abbott today announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries. XIENCE Xpedition features a new stent delivery system designed to optimize acute performance, particularly in challenging coronary anatomies. XIENCE Xpedition is supported by the robust 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, Department of Cardiology, 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, Abbott Vascular. "With XIENCE Xpedition, Abbott continues its commitment to advancing drug eluting stent technology to improve product performance and patient outcomes."
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 lengths from 8 mm to 38 mm.
About the XIENCE Family of Drug Eluting Stents
XIENCE Xpedition is now available in Europe and other countries in Asia and the Middle East.
XIENCE Xpedition is an investigational device, limited by United States law to investigational use and is not approved or available for sale in the United States.
XIENCE PRIME® and XIENCE V® are available in the United States, Europe, the Middle East, Japan and most of Asia.
In the United States, the XIENCE PRIME stent system, including XIENCE PRIME LL (Long Lengths), is 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 PRIME, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_PRIME_Everolimus_Eluting_Coronary_Stent_System.pdf. 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 www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.pdf.
The MULTI-LINK stent design includes MULTI-LINK VISION®, XIENCE V, XIENCE PRIME and, most recently, XIENCE Xpedition. ;More than 11 million implants of the MULTI-LINK platform have occurred worldwide.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, 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 implantation, due to its anti-proliferative properties.
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.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.