Boston Scientific stent issue resolved
St. Paul, Minn. — Boston Scientific has resolved all issues that prompted a 2006 corporate warning letter from the Food and Drug Administration concerning the company's heart stents.
Stents are minute mesh tubes that prop open clogged arteries. In 2006, the FDA cited Boston Scientific for violations in the manufacturing of cardiovascular devices including the Taxus stent, which generated nearly half of its revenue.
The FDA lifted restrictions on the company earlier this year. Boston Scientific said the agency has now declared its plants in compliance with quality systems regulations.
In a statement, Boston Scientific president and Chief executive Ray Elliott said the resolution of the corporate warning letter "marks a major milestone."