Boston Scientific's CEO offers the strongest statement yet that the FDA soon will withdraw its warning letter.
Boston Scientific Corp. said Wednesday that strict sanctions placed on its Maple Grove-based cardiovascular division by federal regulators more than two years ago will likely be cleared up soon.
But exactly when that will happen is unclear.
The Natick, Mass.-based medical technology company has been strongly hinting in recent weeks that it was making progress in resolving its issues with the Food and Drug Administration (FDA).
This is an important hurdle for the company to overcome because the presence of an FDA "warning letter'' prevents Boston Scientific's cardiovascular division, which makes its signature drug-coated heart stent, from getting FDA approval on more sophisticated medical devices. Typically, these devices are among the most lucrative for the company.
The Maple Grove division employs about 2,800 people in the Twin Cities area.
In an earnings conference call with Wall Street analysts Wednesday, Boston Scientific CEO Jim Tobin offered his most-forceful comments to date about the status of the FDA's warning letter.
"We were informed by the FDA [Tuesday] that we are in substantial compliance with its quality system regulations,'' Tobin said, noting the agency "has agreed to remove the restrictions imposed by the corporate warning letter.''
The letter will stay in place until some remaining details are resolved, he said, although he didn't offer a specific date.
FDA spokeswoman Mary Long said Wednesday the agency couldn't comment on the status of the letter. Typically, the agency does not issue a news release when a warning letter is resolved.
"At this point, it's largely a symbolic event,'' said Phil Nalbone, an analyst with RBC Capital Markets. "I really doubt that there will be one singular dramatic announcement that the letter has been lifted, complete with a victory lap by management."
Nonetheless, he said, the previously preoccupied company can concentrate on developing new products. Boston Sci shares closed at $8.19 Wednesday, down 43 cents.
In the past two months, Boston Scientific got FDA approval for two new stents -- Taxus Atom, for treating small vessels, and Taxus Liberté, the company's next-generation drug-coated stent. (Part of a $4 billion market, stents are tiny mesh struts that prop open clogged arteries. When the stents are treated with drugs, the vessels are less likely to reclog.)
Janet Moore • 612-673-7752