The clearances bode well for the company's Maple Grove unit, which may be closer to resolving quality issues with the agency.
Medical technology companies usually cheer when the Food and Drug Administration (FDA) approves a new product, a move that clears the way for sales in the United States. But Boston Scientific Corporation's announcement Thursday that regulators approved a new heart stent seemed a bit more significant than usual for the Natick, Mass., firm.
The news means that the company's Maple Grove-based cardiovascular division, which employs about 2,800 people, could be close to resolving a two-year-old warning letter from the FDA. The letter has prevented the company from introducing highly sophisticated products, usually those that involve clinical studies on patients, until the quality problems highlighted by the agency are resolved.
Boston Scientific said Thursday that the FDA approved a drug-coated stent called Taxus Atom, which is designed to treat coronary artery disease in small blood vessels.
Although the market is relatively small for the product, there are no other U.S. competitors in the niche.
In addition, federal regulators approved the use of the company's market-leading Taxus stent to treat scar tissue in vessels of patients who had previously been treated with an earlier generation, bare-metal stent.
Stents are tiny mesh struts that prop open clogged arteries. When coated with drugs, the vessels are less likely to reclog.
Boston Scientific CEO James Tobin told analysts at an investors meeting in New York on Thursday that the news of the approvals was "important as a signal that we really are making progress on the warning letter, and stay tuned on that front."
The letter outlined quality problems, much of which was related to recordkeeping, in three of the company's facilities, including the one in Maple Grove.
Speaking at the UBS Global Lifesciences Conference, Tobin declined to elaborate about the status of the letter. But he noted that "it's kind of comforting to know that we're actually starting to get approvals."
For investors and industry observers, predicting when the FDA will lift a warning letter is a little like reading tea leaves. Boston Scientific has been circumspect in its predictions. And the FDA does not publicly issue a letter releasing a company, spokeswoman Karen Riley said. Usually, that's left to the company, she said.
'Systems are in place'
The FDA will approve a product by a company working under a warning letter on a case-by-case basis if it's in the interest of advancing public health, said Riley, who declined further comment about the Boston Scientific matter.
The fact that Boston Scientific received the approvals "suggests the FDA feels their systems are in place," Minneapolis attorney and FDA expert Mark DuVal said. "It's not like [FDA device chief] Dan Schultz stands on a podium somewhere and says everything is OK."
The bigger news would have been if the FDA had approved Boston Scientific's next-generation drug-coated stent, Taxus Liberté, according to Tim Nelson, an analyst with FAF Advisors in Minneapolis.
Thursday's news "was really a tiny approval for them," Nelson said. Taxus Atom "isn't new technology or a new platform, and it's not a huge new market."
Tobin told analysts, "When [approval of] Liberté will come, I don't know, but it's got to be closer today than it was yesterday."
Boston Scientific stock closed 37 cents higher Thursday, at $12.98.
Janet Moore • 612-673-7752