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