Abbott announced that both the XIENCE PRIME™ Everolimus Eluting Coronary Stent System(1) and the XIENCE V® Everolimus Eluting Coronary Stent System have received additional new CE Markings (Conformité Européenne) covering the treatment of patients with diabetes. Receiving these new indications among the European Union Member States validates the use of XIENCE PRIME and XIENCE V to treat patients with diabetes.
Coronary artery disease is one of the most common cardiovascular complications of diabetes and is the number one cause of death among European adults with diabetes(2).
"This expanded indication further confirms XIENCE PRIME and XIENCE V as important options for physicians who are treating patients with diabetes," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "Patients with diabetes tend to be sicker and have more challenging anatomy, such as small vessels or long lesions, which can be difficult to treat. The deliverability of both devices provides physicians with confidence to easily reach the lesion site."
In addition to diabetes, XIENCE PRIME and XIENCE V also received CE Mark for expanded indications to treat patients that have complex disease, including dual vessels, small vessels and jailed side branches (small side branches of less than 2.0 mm in diameter that are covered, or "jailed," when a larger artery is stented). The expanded indications for XIENCE PRIME and XIENCE V are based on randomized clinical trial data from the SPIRIT family of trials that support the safety and performance of the stents in these patient subgroups. XIENCE PRIME also is indicated for use in long vessels and is available in stent lengths of 33 mm and 38 mm. Both XIENCE PRIME and XIENCE V leverage the excellent outcomes from the extensive body of clinical evidence from the SPIRIT family of clinical trials. Most recently, data from the company's SPIRIT IV trial comparing XIENCE V to the TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in September 2009. With 3,690 patients, the SPIRIT IV trial is one of the largest head-to-head randomized clinical trials between two drug eluting stents and includes more than 1,100 patients with diabetes.
XIENCE PRIME and XIENCE V are based upon the well-tested design utilized in the MULTI-LINK VISION® 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.
XIENCE PRIME received CE Mark in June 2009, and XIENCE V received CE Mark in 2006. XIENCE PRIME is an investigational device in the United States and is not available for sale in the United States or outside of jurisdictions in which the product has been CE Marked. These additional indications apply to XIENCE V exclusively in countries where the product bears a CE Mark.
About Diabetes and Cardiovascular Disease
The high blood glucose levels associated with diabetes can lead to increased deposits of fatty materials on the insides of the blood vessel walls. These deposits may affect blood flow to the heart, increasing the chance of clogging and hardening of blood vessels. Patients with diabetes who also have coronary artery disease often have poorer outcomes after stent procedures because their blood vessels tend to build up more plaque than the vessels of non-diabetic patients, and their coronary artery disease advances more quickly.
About XIENCE PRIME and XIENCE V
XIENCE PRIME is the latest innovation from Abbott's robust vascular research program and is commercially available in CE Mark countries. XIENCE PRIME offers a novel stent design and a delivery system designed for greater flexibility and enhanced deliverability. XIENCE PRIME is available in a broad size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL for long lesions.
Abbott's market-leading XIENCE V drug eluting stent is commercially available 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.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS® Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.
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.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions less than or equal to 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE PRIME and XIENCE V, including important safety information, is available online at www.xienceprime.com and www.xiencev.com.
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.
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.
1. XIENCE PRIME is an investigational device in the United States and is not available for sale.
2. Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary: The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007;28(1):88-136