Boston Scientific to resume defibrillators sales
16 Apr 2010
US medical devices maker Boston Scientific Corporation said yesterday that the US Food and Drug Administration (FDA) has allowed it to resume distribution of its defibrillators after having failed to inform federal regulators to changes made in manufacturing of its best-selling devices last month.
On 15 March 2010 the Natick, Massachusetts-based company had stopped shipment and recalled unused units of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) for failing to notify regulators about manufacturing and process changes to the devices. (See: Boston Scientific suspends sales of seven defibrillators)
Medical device makers are required by law to inform regulators of any significant changes made to life-sustaining devices like defibrillators, and Boston Scientific's Arden Hills-based Guidant division failed to submit the necessary papers of the changes made to the manufacturing process.
The halt in sales involve seven brands of Boston Scientific defibrillators that regulate heart beats and also send electrical pulses to the hearts of patients when it senses cardiac arrest.
The company said the FDA cleared two manufacturing changes to the Cognis cardiac resynchronisation therapy defibrillator (CRT-D) and the Teligin implantable cardioverter defibrillator (ICD) but is yet to clear five older products, documentations of which it has now submitted.
The five products, Confient, Livian, Prizm, Renewal and Vitality are the earlier generations of the company's CRT-D and ICD products, which is still being sold outside of the US.
Cognis and Teligen, both launched in the market over the past two years, generated approximately 15 per cent of Boston Scientific's 2009 sales of $8.2 billion.
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