Medical Device Link.

Originally Published MX September/October 2004

BUSINESS NEWS

In a continuing effort to determine the extent of manufacturing problems related to the catheter delivery system for Taxus drug-eluting and Express bare-metal coronary stents by Boston Scientific (Natick, MA), FDA has announced plans to inspect the company's production facility in Galway, Ireland, in "the near future."

The agency's decision to inspect the Galway plant was first revealed by the Wall Street Journal and was picked up by numerous news services. There is no mention of the inspection on FDA's Web site, nor has the agency announced a date for its site visit. Similarly, Boston Scientific had no public comment on the matter.

Boston Scientific has recalled 99,200 stents in three separate actions since July 2. The recalls were necessitated by continuing problems with balloon deflation failure and associated catheter retraction difficulties, which have reportedly resulted in three deaths and 43 serious injuries. Boston Scientific attributed the problem to "focal neckdown," a phenomenon that can occur if too much laser heat is applied during the manufacturing process that bonds the balloon to the catheter. In May, the company notified FDA of a change in the manufacturing process, which was intended to result in a more robust bond.

Reportedly, FDA does not anticipate any further recalls, but is seeking to determine whether any additional stents made before the manufacturing change are likely to exhibit similar balloon deflation failures. Most of the affected stents were manufactured in Galway; no significant occurrences have been reported for units produced at the company's other coronary stent facility in Maple Grove, MN.

Before the recall problems, Taxus had captured 70% of the U.S. drug-eluting stent market and was expected to account for 40% of Boston Scientific's revenues in 2004. Analysts suggest that the company has experienced some market loss. But they also note that Taxus's only U.S. competitor—the Cypher drug-eluting stent from Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company—is not in a strong position to take away market share. Cordis has been cited with an FDA Warning Letter concerning the quality systems at its Cypher manufacturing plants in the U.S. and abroad.

In a related matter, FDA permitted Boston Scientific to increase the stated shelf life of the Taxus stent from six to nine months. Although the agency said the action was unrelated to the recall issue, many analysts interpreted the move as positive. Commenting on the decision, Standard & Poor's (New York City) said that "while there could be additional recalls of older Taxus units, we think FDA would not have moved forward with a shelf-life extension if it felt balloon deployment issues remain on newly made units."

Meanwhile, Boston Scientific is moving quickly to get beyond the balloon deflation failure and catheter delivery problems that have marred the stunningly successful launch of Taxus. The company recently announced that it has begun to enroll patients in the Atlas trial of its next-generation drug-eluting stent, Liberté.

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