Boston Scientific Corp. has received a Food and Drug Administration "approvable letter" for its Taxus Liberte drug-coated stent heart device, which has long been held back from the U.S. market by company regulatory issues, an official said Tuesday.
An FDA approvable letter usually indicates that the agency is prepared to approve a product but must first review more information.
Speaking at a Lehman Bros. health care conference, Paul LaViolette, Boston Scientific's chief operating officer, said the device is now in "compliance hold" as Boston Scientific works to resolve a long- standing corporate warning letter from the FDA.
The FDA issued the warning letter in January 2006 because of issues at multiple Boston Scientific facilities, including one in Maple Grove. Because the FDA can hold back on approving company devices until warning-letter issues are fixed, the letter has been blocking approval for the Taxus Liberte stent.
The device, on sale overseas, is a follow-up to the version of Taxus that has been the top-selling coated stent in the U.S. market. Coated stents are tiny devices used to prop open heart arteries and that use medication to combat renarrowing.
Medtronic entered the U.S. market with its Endeavor drug-coated stent last month, breaking up a duopoly for the devices long held by Boston Scientific and rival Johnson & Johnson.
DOW JONES NEWS SERVICE
