Guidant Changes Recommendation

Guidant Corp. of Indianapolis said it has changed an earlier recommendation to doctors treating patients implanted with some models of its defibrillators after realizing the earlier guidance may have put patients at greater risks. The recommendation had been made after the company found that some of its implantable cardioverter defibrillators (ICDs) could malfunction and lead to injury or death.

The company on July 22 alerted doctors to ignore its earlier recommendation to make programming changes to the devices, which include the Ventak Prism AVT, Vitality AVT, and Contak Renewal AVT defibrillators. The company has instead told doctors to alter its programming, although it declined to specify the change.

Over the past several months, the company has been inundated by malfunctioning products, beginning with ICDs and later expanding to pacemakers. On July 18, the company warned patients and doctors that nine different models of older pacemakers were susceptible to leaks.

The announcements have been especially untimely for the company, which is being acquired by New Brunswick, NJ-based Johnson & Johnson in a $24.5 billion deal.  Even after Guidant’s disclosure of the problem products, J&J officials said they were still looking forward to executing the deal. However, analysts have said the company is likely to negotiate for a lower price.