June 23, 2009 / 12:05 PM / 10 years ago

Abbott says new Xience stent approved in Europe

* Xience Prime stent modified for easier placement in body

* Abbott will begin selling the new device in Europe in Q3

* Aims for U.S. launch in first-half 2012 or earlier

By Susan Kelly

CHICAGO, June 23 (Reuters) - Abbott Laboratories (ABT.N) on Tuesday said European regulators approved a new, more flexible version of its Xience drug-eluting stent that is designed for easier placement in the diseased coronary artery.

The new Xience Prime stent incorporates the same drug, polymer and cobalt chromium technology as Abbott’s top-selling Xience V stent, but improves on the design to make it easier for the physician to insert into the targeted coronary artery, Abbott said.

The new stent also will come in more sizes, including versions for small vessels and long lesions.

A stent is a small wire-mesh tube that props open the walls of an artery that has been surgically cleared of plaque and delivers medicine to keep it from reclogging. It is inserted into the body through a catheter usually at the large vessel in the groin and then threaded through to the treatment area.

Abbott said it will begin selling the Xience Prime stent in Europe in the third quarter and hopes to introduce the product in the U.S. market by 2012.

Abbott recently began enrolling patients in its Spirit Prime clinical trial that will be used to study the performance of the Xience Prime stent and support a regulatory filing with the U.S. Food and Drug Administration to sell the product in the United States.

“We would expect to be submitting for U.S. approval in first-half 2011 and have the product in the United States in first-half 2012, but it could be earlier,” John Capek, Abbott’s executive vice president for medical devices, said in an interview.

The company competes with Boston Scientific Corp (BSX.N), Johnson & Johnson (JNJ.N) and Medtronic Inc (MDT.N) in the lucrative market for the devices. All are developing next-generation stent products.

Abbott’s Xience V stent now has a 27 percent market share in Europe, similar to its position in the United States, Capek said. “We would expect with the launch of Xience Prime to see our market share position increase,” he said.

Abbott also expects to launch Xience V in Japan — a key market where it does not currently compete — by the end of this year, Capek said.

Abbott expects Xience Prime ultimately to replace Xience V in Europe and the United States due to its improved deliverability and broader range of available sizes, Capek said.

The company is also developing a stent whose components can be fully absorbed by the body within two years, leaving behind a vessel that can function without the stent.

So far, 30 patients have successfully received that stent in the first stage of a clinical trial, Abbott said. Enrollment in the second phase, involving an additional 80 patients, is under way. The company anticipates its bioabsorbable stent could be on the market in Europe in 2013. (Reporting by Susan Kelly, Editing by Maureen Bavdek)

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