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Abbott's XIENCE PRIME(TM) and XIENCE V(R) Receive Indications in Europe for Treatment of Patients with Diabetes
Monday, November 02, 2009 9:53 AM


BRUSSELS, Nov. 2, 2009 (PR Newswire Europe) -- v>

- CE Markings for Additional New Indications Further Validate Use of Abbott's Drug Eluting Stents in Treating a Range of High-Risk and Complex Patients

Abbott (NYSE: ABT) today announced that both the XIENCE PRIME(TM) Everolimus Eluting Coronary Stent System(1) and the XIENCE V(R) Everolimus Eluting 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 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(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System were presented at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in September 2009.




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