Press Release

Abbott's XIENCE PRIME(TM) and XIENCE V(R) Receive Indications in Europe for Treatment of Patients with Diabetes

AbbottPosted on:04 Nov 09
Abbott's XIENCE PRIME(TM) and XIENCE V(R) Receive Indications in Europe for Treatment of Patients with Diabetes- CE Markings for Additional New Indications Further Validate Use of Abbott's Drug Eluting Stents in Treating a Range of High-Risk and Complex PatientsPR NewswireBRUSSELS, November 2

BRUSSELS, November 2 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that both the XIENCE PRIME(TM)Everolimus Eluting Coronary Stent System(1) and the XIENCE V(R) EverolimusEluting Coronary Stent System have received additional new CE Markings(Conformite Europeenne) covering the treatment of patients with diabetes.Receiving these new indications among the European Union Member Statesvalidates the use of XIENCE PRIME and XIENCE V to treat patients withdiabetes. Coronary artery disease is one of the most common cardiovascularcomplications of diabetes and is the number one cause of death among Europeanadults with diabetes(2).

"This expanded indication further confirms XIENCE PRIME and XIENCE V asimportant options for physicians who are treating patients with diabetes,"said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, MedicalAffairs, and chief medical officer, Abbott Vascular. "Patients with diabetestend to be sicker and have more challenging anatomy, such as small vessels orlong lesions, which can be difficult to treat. The deliverability of bothdevices provides physicians with confidence to easily reach the lesion site."

In addition to diabetes, XIENCE PRIME and XIENCE V also received CE Markfor expanded indications to treat patients that have complex disease,including dual vessels, small vessels and jailed side branches (small sidebranches of less than 2.0 mm in diameter that are covered, or "jailed," whena larger artery is stented).

The expanded indications for XIENCE PRIME and XIENCE V are based onrandomized clinical trial data from the SPIRIT family of trials that supportthe safety and performance of the stents in these patient subgroups. XIENCEPRIME also is indicated for use in long vessels and is available in stentlengths of 33 mm and 38 mm. Both XIENCE PRIME and XIENCE V leverage theexcellent outcomes from the extensive body of clinical evidence from theSPIRIT family of clinical trials. Most recently, data from the company'sSPIRIT IV trial comparing XIENCE V to the TAXUS(R) Express2(TM)Paclitaxel-Eluting Coronary Stent System were presented at the TranscatheterCardiovascular Therapeutics (TCT) annual meeting in September 2009. With3,690 patients, the SPIRIT IV trial is one of the largest head-to-headrandomized clinical trials between two drug eluting stents and includes morethan 1,100 patients with diabetes.

XIENCE PRIME and XIENCE V are based upon the well-tested design utilizedin the MULTI-LINK VISION(R) family of stents, which is the most widely usedstent platform in the world - more than 2 million of Abbott's cobalt chromiumstents have been implanted worldwide.

XIENCE PRIME received CE Mark in June 2009, and XIENCE V received CE Markin 2006. XIENCE PRIME is an investigational device in the United States andis not available for sale in the United States or outside of jurisdictions inwhich the product has been CE Marked. These additional indications apply toXIENCE 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 toincreased deposits of fatty materials on the insides of the blood vesselwalls. These deposits may affect blood flow to the heart, increasing thechance of clogging and hardening of blood vessels. Patients with diabetes whoalso have coronary artery disease often have poorer outcomes after stentprocedures because their blood vessels tend to build up more plaque than thevessels of non-diabetic patients, and their coronary artery disease advancesmore quickly.

About XIENCE PRIME and XIENCE V

XIENCE PRIME is the latest innovation from Abbott's robust vascularresearch program and is commercially available in CE Mark countries. XIENCEPRIME offers a novel stent design and a delivery system designed for greaterflexibility and enhanced deliverability. XIENCE PRIME is available in a broadsize matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LLfor long lesions.

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

Abbott also supplies a private-label version of XIENCE V to BostonScientific called the PROMUS(R) Everolimus-Eluting Coronary Stent System.PROMUS is designed and manufactured by Abbott and supplied to BostonScientific as part of a distribution agreement between the two companies.

Everolimus, developed by Novartis Pharma AG, is a proliferation signalinhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on itsdrug eluting stents. Everolimus has been shown to inhibit in-stent neointimalgrowth in the coronary vessels following stent implantation, due to itsanti-proliferative properties.

XIENCE V is indicated for improving coronary luminal diameter in patientswith symptomatic heart disease due to de novo native coronary artery lesions(lesions less than or equal to 28 mm) with reference vessel diameters of 2.5mm to 4.25 mm. Additional information about XIENCE PRIME and XIENCE V,including important safety information, is available online atwww.xienceprime.com, www.xiencev.com orwww.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world's leadingvascular care businesses. Abbott Vascular is uniquely focused on advancingthe treatment of vascular disease and improving patient care by combining thelatest medical device innovations with world-class pharmaceuticals, investingin research and development, and advancing medicine through training andeducation. Headquartered in Northern California, Abbott Vascular offers acomprehensive portfolio of vessel closure, endovascular and coronaryproducts.

About Abbott

Abbott is a global, broad-based health care company devoted to thediscovery, development, manufacture and marketing of pharmaceuticals andmedical products, including nutritionals, devices and diagnostics. Thecompany employs more than 72,000 people and markets its products in more than130 countries.

Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.

(1) XIENCE PRIME is an investigational device in the United States and isnot available for sale.

(2) Ryden L, Standl E, Bartnik M, et al. Guidelines on diabetes,pre-diabetes, and cardiovascular diseases: executive summary: The Task Forceon Diabetes and Cardiovascular Diseases of the European Society of Cardiology(ESC) and of the European Association for the Study of Diabetes (EASD). EurHeart J 2007;28(1):88-136

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