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Long-term data key as FDA panel reviews Abbott Laboratories' drug-coated stent Xience

Government health advisers are scheduled to vote Thursday on whether Abbott Laboratories' drug-coated stent Xience should be approved for use in the U.S.
/ Source: The Associated Press

Government health advisers are scheduled to vote Thursday on whether Abbott Laboratories' drug-coated stent Xience should be approved for use in the U.S.

The Food and Drug Administration is expected to ask its panel of heart device experts if Abbott has collected enough data to ensure Xience's safety.

In preliminary two-year results compiled by Abbott comparing Xience with Boston Scientific's Taxus stent, patients with the Abbott device had 50 percent fewer major heart problems. However, in Tuesday's review of the data, FDA advisers cautioned against making firm conclusions based on Abbott's analysis.

Stents are tiny mesh tubes used to prop open clogged arteries once they've been cleared of plaque. The drug coatings are designed to keep the vessels clear of blockage.

Use of drug-coated stents compared with bare-metal stents has shrunk to 65 percent from 85 percent last year, as doctors reacted to recent evidence that drug coatings may cause dangerous blood clots.

Analysts expect Thursday's meeting to focus on whether Abbott has adequate long-term data on the safety of Xience. The company will present two-year results from an ongoing study of 400 patients at Thursday's meeting. When competitor Medtronic Inc. presented to the same panel last month, it had two-year data on 1,300 patients. The panel unanimously recommended approval for its Endeavor stent, which is expected to get FDA clearance by 2008.

FDA generally follows the guidance of its panels, though it's not required to.

JP Morgan analyst Michael Weinstein reiterated an "Overweight" rating on Abbott shares, but said Thursday's meeting could be challenging for Abbott because of the limited data.

Wachovia analyst Larry Biegelsen estimated the stent has a 50-50 chance of getting the panel's approval. While Biegelsen expects Xience to eventually be the leading stent in the U.S., he said the FDA could delay approval until late 2008 to gather additional data.

Boston Scientific Inc.'s Taxus and Johnson & Johnson's Cypher are the only drug-coated stents on the U.S. market.