FDA keeps Boston Scientific stent on hold
Boston Scientific Corp. is still trying to persuade federal regulators to approve its next generation stent. The Natick medical-device maker received an "approvable" letter from the Food and Drug Administration for its Taxus Liberté stent. Such a letter typically means the FDA needs more information before approving a product. The agency declined comment.
The decision is moot for now because Boston Scientific is barred from rolling out new stent products until it clears up FDA concerns about its quality systems. The company has previously said it expects the FDA to lift its "corporate warning letter" in mid-2008, clearing the way for it to roll out new products. Boston Scientific spokesman Paul Donovan said the company hopes to win approval for Liberte shortly after its corporate warning letter is lifted.
The Liberté is the company's newest version of the tiny drug-coated devices which are used to prop open cleared arteries. It is already widely used overseas.
But if Boston Scientific cannot resolve the FDA's questions about Liberté quickly, it could delay the product's launch. That's key because the company is expected to face increased competition in the stent market this year from Abbott Laboratories and Medtronic Inc., which plan to begin selling drug-coated stents in the United States for the first time.
Previously, Boston Scientific and Johnson & Johnson were the only companies with permission to sell drug-coated stents in the United States.
Boston Scientific could not be immediately reached for comment.
(By Todd Wallack, Globe staff)