Defibrillators

Until the underlying issues are resolved, the FDA will not approve key new products.Boston Scientific acquired Guidant for $27 billion soon after the FDA issued its warning, and since then has sunk significant resources into fixing Guidant's manufacturing and quality problems.

Chief executive Jim Tobin has said he is spending as much time at Guidant's Minnesota facility as he does at Boston Scientific's headquarters ."Since I run the company, I get to appoint who runs Guidant, so I appointed me," he told the Globe in January.In November and December, a year after issuing the Guidant warning, FDA officials re-inspected Guidant's facility, assessed new quality-control systems put in place by Boston Scientific, and did not observe any problems, the company said yesterday."We are very pleased with the FDA's conclusion," Tobin said yesterday.A spokeswoman for the FDA said the issues raised in the warning "appear to have been adequately addressed," and the agency will continue to monitor Guidant's products and recalls.Still in force, however, is a companywide warning letter Boston Scientific received from the FDA in January 2006.

That letter applies to its drug-coated stent business and the rest of the pre-Guidant areas of the company.

Executives have s...

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