Abbott Receives CE Mark For Company's Next-Generation XIENCE PRIME(TM) Drug Eluting Stent, Advancing Leadership Position

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 24 Jun 2009 - 3:00 PDT

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Abbott announced that it has received CE Mark (Conformite Europeenne) for its next-generation XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. The company plans to launch XIENCE PRIME in a broad size matrix with lengths up to 38 mm in Europe in the third quarter.

"XIENCE PRIME leverages and will build upon the outstanding body of clinical evidence from the SPIRIT family of clinical trials. The modified design features of the stent and delivery system are intended to make it easier for physicians to deliver the stent to the treatment area," said Robert Hance, senior vice president, vascular, Abbott. "As part of Abbott's leadership in drug eluting stents, we are committed to advancing treatment options and look forward to making the innovative XIENCE PRIME stent available to physicians and patients in Europe in the upcoming months."

XIENCE PRIME utilizes the same well-studied drug and proven biocompatible polymer as Abbott's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System. In addition, it offers a novel stent design and a modified delivery system designed for greater flexibility and improved deliverability. XIENCE PRIME uses cobalt chromium technology, which allows for very thin struts while maintaining strength to support the vessel as well as excellent visibility under X-ray during the stent implantation procedure. XIENCE PRIME is based upon the proven design of the MULTI-LINK(R) family of stents, which is the most widely used stent platform in the world - more than 2 million of Abbott's cobalt chromium stents have been implanted worldwide. Upon launch in Europe, XIENCE PRIME will be available in an expanded size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions.

Abbott's robust vascular research program includes clinical trials in coronary artery disease and peripheral artery disease. Key products in the vascular pipeline include: the MULTI-LINK 8(TM) Coronary Stent System, a next-generation frontline balloon dilatation catheter, a fully bioabsorbable drug eluting coronary device, and the Omnilink Elite(TM) Peripheral Stent System.

The MULTI-LINK 8 Coronary Stent System, the next-generation frontline balloon dilatation catheter, the fully bioabsorbable drug eluting device and the Omnilink Elite Peripheral Stent System are in development and are not available for sale.

XIENCE PRIME currently is an investigational device in the United States and not available for sale.

About XIENCE V

Abbott's market-leading XIENCE V drug eluting stent is marketed in the United States, Europe and other international markets. XIENCE V is an investigational device in Japan and is currently under review by Japan's Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.

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 stents. 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, a division of Abbott, is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

About Abbott

Abbott 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 more than 72,000 people and markets its products in more than 130 countries.

Source: Abbott