Initial Public Comments on Implantable Cardiac Guidant Pacemaker Recall

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Guidant Pacemaker Recall:

Thank you for the opportunity that I had to meet with you earlier this year to discuss the results of the DEFINITE trial and of defibrillator use in patients with nonischemic dilated cardiomyopathy. At that time you raised several questions regarding some details of the DEFINITE trial and the result of the DEFINITE trial and the SCD-HeFT trial. Since I now have access to some additional information regarding some of the questions that were raised, I thought a follow-up note would be appropriate.

I will confine my comment to patients with nonischemic dilated cardiomyopathy, although I concur with many of the previously posted comments regarding ischemic in response to CAG- 000157R1. The DEFINITE trial demonstrated a 35% reduction in overall mortality when patients receive the ICD compared to standard medical therapy. In the SCD-HeFT trial a 25% reduction in overall mortality is noted despite small differences in selection criteria. These results are highly concordant and within the range of difference that can be expected with repeated trials of the same experiment. In the DEFINITE trial there was a non-significant trend for patients with Class III congestive heart failure to have a greater benefit from the ICD. In contrast, in the overall SCD-HeFT population an opposite trend was present. Although I do not have full access to the SCD-HeFT database, at a presentation last week, in an international meeting the SCD-HeFT investigators broke out their result in ischemic and nonischemic cardiomyopathy based on the class of heart failure. Patients with NYHA Class III congestive heart failure and nonischemic cardiomyopathy had a mortality that was 18%-20% lower when receiving an ICD than when receiving standard therapy. This was similar although slightly lower in magnitude for the benefit in nonischemic cardiomyopathy seen in Class II patients. Given the substantial overlap in confidence intervals in the nonischemic patient populations in both studies, I believe that the effect of heart failure class on ICD benefit was not substantially different between the 2 studies. It appears that the ICD can benefit with Class II and Class III congestive heart failure with nonischemic cardiomyopathy. In the DEFINITE trial we also studied almost 100 patients with Class I heart failure at the time of randomization. There was a small trend toward ICDs benefiting this group of patients as well, although the study was obviously not powered to detect a significant difference.

In summary, I believe that the combined results of both DEFINITE trial and SCD-HeFT trial lead to the conclusion that ICD therapy will benefit patients with nonischemic cardiomyopathy and ejection fraction less that 36%. I urge CMS to approve this lifesaving therapy'

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see also:

Current Medicare Criteria Comment Guidant Cardiac Defibrillators Initial Public Comments 7
Public Comments on Guidant's Implantable Cardiac Defibrillators

April 2007 Recall--'Doctor's Letter' Boston Scientific/Guidant Contak, Vitality Defibrillators Recalled
accelerated battery depletion sparks recall for some defibrillators

News & Warnings Guidant Defibrillator - Public Commentary on Defibrillators and the Guidant Recall
Guidant defibrillator recall public comment. FREE lawsuit information