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Heather Mayer, DOTmed News Reporter | March 31, 2010
The FDA has rejected a request to expedite a review of Boston Scientific's recalled implantable cardiac defibrillator manufacturing operations, the Wall Street Journal reports. The agency will review the claim in its normal 30-day period. The Journal estimates that the company is losing $5 million a day in sales with the products off the market. A federal investigation is underway.
The March 15 recall (See DM 11997) affected all seven of the company's defibrillator brands.
The company announced last month, prior to the recall, a reorganization plan that is expected to eliminate 1,300 jobs worldwide, according to Medical Device Link.
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Estimates from Leerink Swann, a healthcare investment bank, state that Boston Scientific would return to the market by mid-April, following the FDA review. Leerink Swann also reports that uncertainties surrounding the length of Boston Scientific's shipment hold, the longer-term implications for the company's ICD market share, market growth and any impact to other Boston Scientific businesses.
