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Boston Scientific clears up problems at Minnesota plant
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BOSTON Boston Scientific Corp. on Monday said regulators have lifted a warning about quality-control problems at a Minnesota plant that makes defibrillators and pacemakers, enabling the company to resume seeking approval for new devices to correct abnormal heartbeats.
Shares of Boston Scientific rose nearly 8 percent after the announcement, which clears up one of two quality control warnings the company faces from the Food and Drug Administration. The one that is still pending, dating from January 2006, involves problems with systems to detect and respond to potentially defective and unsafe products other than so-called heart rhythm devices.
The quality-control warning that's now lifted dates to December 2005, when regulators cited manufacturing and record-keeping problems at a plant in St. Paul, Minn. The company, based in Natick, Mass., acquired that plant in April 2006 when it bought Guidant Corp. for $27 billion.
The 2005 warning prompted Boston Scientific to revamp systems to detect product defects and other problems. The FDA re-inspected the plant last November and again in December, and found no problems, the company said.
"The principal benefit will be to allow new CRM (cardiac rhythm management) products to be considered for approval," said Paul Donovan, a spokesman for Boston Scientific.
The decision also means Boston Scientific is eligible to receive certificates needed to conduct overseas marketing for devices made at the St. Paul facility.
The warning at the St. Paul plant did not hold up any major new product approvals involving Guidant's line of defibrillators and pacemakers that Boston Scientific acquired last year.
But the still-pending warning is holding up the FDA's potential approval of the Taxus Liberte heart stent, a next-generation version of Boston Scientific's top-selling product, the Taxus drug-coated stent. Sales have been hurt recently by news that the Taxus and a rival product from Johnson & Johnson slightly increase the risk of blood clots long after artery-clearing surgery.
Boston Scientific's shares rose $1.18 to $16.19 in late morning trading on the New York Stock Exchange.
The stock has struggled to recover from a 30 percent drop last year amid investor worries about the Guidant acquisition, including product recalls and the safety warnings, as well as legal liability for those problems.
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