Boston Scientific Says Plant Problems Resolved
Boston Scientific said on Monday it had resolved deficiencies that U.S. regulators had found at a plant that manufactures heart rhythm devices, sending its shares up nearly 7%.
The resolution of the deficiencies will allow the company to win U.S. approvals for new heart-rhythm products, such as pacemakers and defibrillators.
The Food and Drug Administration reinspected the St. Paul, Minnesota, plant between Nov. 9 and Dec. 7. Guidant, which Boston Scientific acquired last year, had owned the facility, and the FDA had issued that company a warning letter about the deficiencies on Dec. 22, 2005.
"We are very pleased with the FDA's conclusion," Boston Scientific Chief Executive Jim Tobin said in a statement.
The FDA issued the warning letter for production and quality problems after Guidant recalled thousands of defibrillators in 2005 after news reports revealed they could malfunction within patients' chests.
Boston Scientific acquired Guidant for $27 billion, winning a bidding war with Johnson & Johnson.
Boston Scientific still must resolve a second warning letter that cited quality control and systems problems at the company's facilities in Natick, Massachusetts; Maple Grove, Minnesota; and Spencer, Indiana.
Because of that letter, the company has faced a freeze on other product approvals, including its next-generation drug-eluting stent called Taxus Liberte.
Boston Scientific shares were up $1, or 6.7%, at $16.01 on the New York Stock Exchange.