Guidant Ceases Stents Due to Quality Issues

Guidant Corp. has announced it won’t sell its stock of Xience V drug-coated stents because some of the products failed to meet the company’s manufacturing standards, the medical device maker said yesterday.
    The Indianapolis company also will stop enrolling patients in a clinical trial for the Xience V Everolimus stent and have delayed the European debut of the product until the third quarter.
    Company executives had hoped to start selling the stent in the second quarter after European regulators approved it in January.
The stent is not on the market in the United States.
    The company said the quality assurance problems affected a small part of its Xience V inventory. The exact number of those affected was not immediately available.
    ”Guidant is committed to providing the highest-quality products for the treatment of heart disease,” John Capek, the president of the company’s vascular intervention division, said in a statement.
    Capek said rebuilding the stents will lead to a $15 million charge in the first quarter to write off current inventory.
    Guidant spokeswoman Kim Boetsch said the problem wasn’t a design flaw, and engineers fixed the root cause and resumed making the stents.
    Boston Scientific plans to sell Guidant’s vascular business, including its line of drug-coated stents, to Abbott in a deal valued at $6.4 billion.
    That includes $4.1 billion in cash, a $900 million loan and will acquire $1.4 billion of Boston Scientific common stock.
    Since June, Guidant has recalled or issued safety advisories for about 88,000 defibrillators and more than 200,000 pacemakers. At least seven deaths have been linked to the faulty devices.
    Guidant officials said they notified the Food and Drug Administration, the safety board of the clinical trial, Boston Scientific and Abbott about their decision to shelve the stents.