GO
Loading...

Enter multiple symbols separated by commas

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.

Contact U.S. News

  • CNBC NEWSLETTERS

    Get the best of CNBC in your inbox

    Please choose a subscription

    Please enter a valid email address
    To learn more about how we use your information,
    please read our Privacy Policy.

Don't Miss

U.S. Video

  • CEO discuss the 'Buffett factor'

    John Stumpf, Wells Fargo chairman & CEO; Kenneth Chenault; American Express chairman & CEO; Ginni Rometty, IBM chairman & CEO; and Muhtar Kent, Coca-Cola chairman & CEO, discuss their relationships with Warren Buffett and marvel at just how easy it's been to communicate with him.

  • Rometty on Watson: He never stops learning

    IBM CEO Ginni Rometty talks Watson, and how it's going to help people make decisions. It never stops learning, she says. Rometty also discusses the company's dividend.

  • Why Buffett bought more IBM

    Berkshire CEO Warren Buffett addresses his purchase of more IBM shares and allegations of predatory lending at Clayton Homes.