FDA experts to vote on Abbott stent
Drug-coated device could be next to enter market as panel considers report showing strong data vs. competing stent.
NEW YORK (CNNMoney.com) -- Food and Drug Administration advisers will decide this week whether they think America is ready for another drug-coated stent.
If Xience gets the green light, it will compete with Boston Scientific's (Charts, Fortune 500) Taxus, which is already on the market, and possibly with Medtronic's (Charts, Fortune 500) Endeavor, which in October was recommended for approval by FDA advisers. In this $3 billion market, it will also compete with the older-model bare metal stents.
Drug-coated stents have been on the U.S. market since 2003. They are wire mesh tubes inserted into arteries during angioplasty to help heart disease patients avoid blood clots. The stents have come under scrutiny for reportedly causing bleeding, though the reports are inconclusive.
Some analysts believe that Abbott has a good shot of getting Xience past the FDA because of recently released reports from Abbott. On Tuesday, Abbott released an update from an earlier study, first released in March, that showed the superiority of Xience over Taxus.
"Based on the clinical data revealed so far - and especially the clear evidence of statistically significant superiority to Boston Scientific's market-leading Taxus - we expect the panel to vote for approval of the Abbott device," said Phil Nalbone, analyst for RBC Capital Markets, in a published report.