Initial Public Comments on Implantable Cardiac Guidant Defibrillators

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Comment Two
May 25-June 25, 2004
Comment #2:
Name: Michael J. Coyle
Organization: St. Jude Medical, Inc.
Date: June 25, 2004

St. Jude Medical, Inc., a developer, manufacturer, and distributor of innovative medical devices including implantable cardioverter defibrillators (ICDs), appreciates the opportunity to provide additional comments regarding CMS¡¦ consideration of expanded indications under the National Coverage Determination for Implantable Cardioverter Defibrillators (35-85) following the publication of DEFINITE and COMPANION trial results in the New England Journal of Medicine (May 20, 2004). This letter reiterates our position, outlined in comments to CMS on April 30, 2004, and expands upon recently published data.

As stated previously, St. Jude Medical believes that significant and compelling scientific evidence has been provided to CMS in the SCD-HeFT clinical trial to clearly demonstrate that the use of ICD therapy significantly reduces all-cause mortality compared to conventional medical therapy and is appropriate, reasonable and necessary for the treatment of patients with NYHA Class II and III congestive heart failure, a left ventricular ejection fraction of equal to or less than 0.35, and no prior history of ventricular tachyarrhythmias. This all-cause mortality reduction was present despite subgroup analysis performed to determine if ECG measures of QRS duration ( >120 versus < 120 msec.) could be used to stratify patients in such way as to define a patient subgroup who might benefit most from primary prevention ICD therapy (the MADIT II population).

We believe that the DEFINITE clinical study adds further validity to the SCD-HeFT and COMPANION non-ischemic cardiomyopathy patient data, which clearly demonstrates that the use of ICD or CRT-D (BiV ICD) therapy significantly reduces all-cause mortality compared to conventional medical therapy and is appropriate, reasonable and necessary for the treatment of non-ischemic cardiomyopathy patients with NYHA Class II and III congestive heart failure, a left ventricular ejection fraction of equal to or less than 0.35, and no prior history of ventricular tachyarrhythmias. The combined results of DEFINITE, SCD-HeFT, and COMPANION in the non-ischemic cardiomyopathy population support a coverage decision of this patient group [the DEFINITE indications].

With regard to the COMPANION study, we believe that these results also support those of SCD-HeFT and DEFINITE for Class III combined ischemic and non-ischemic patients with a hazard ratio of 0.64 favoring CRT-D therapy and a relative reduction of overall mortality of 36% as compared with conventional medical therapy for heart failure. The COMPANION data support the prescription of a CRT-D in such patients who also have ventricular dysynchrony and NYHA functional Class III heart failure symptoms. Specific to the COMPANION study Class III non-ischemic patient subgroup, the hazard ratio was 0.50 favoring CRT-D therapy and a relative reduction of overall mortality of 50% as compared with conventional medical therapy for heart failure, which further supports the value of CRT-D therapy in this DEFINITE¡Vlike subgroup.

In summary, we recommend that CMS:

We believe that physicians are in the best position to determine the most appropriate device for patients based on the specific and unique circumstances of each individual case. For example, for patients with paroxysmal AF or 1:1 retrograde VT, there is a need for dual chamber SVT/VT discrimination features which can reduce morbidity from inappropriate shocks. Patients with a standard indication for bradycardia pacing may require dual-chambered pacing as a treatment option in addition to receiving ICD treatment of their ventricular tachyarrhythmias. Various versions of ICD devices also provide diagnostic information for accurate arrhythmia management (e.g., dual-chamber EGMs). And, finally, there is a need for flexibility as patients' conditions often change from disease progression resulting in the need to upgrade device therapy and tailor it to the patients¡¦ specific needs. For example, over 25% of patients develop or are first diagnosed with atrial fibrillation after they have a device implanted. To optimize patient care, device choice must remain with the physician, not set in policy.

In addition, the results of the DINAMIT Study, a trial that investigated the benefit of implanting ICDs in the period immediately following an acute MI, do not support changing CMS coverage guidelines with regard to waiting 1 month after an AMI to implant an ICD in the MADIT II population.

Regarding the questions posted by CMS to the NCA Tracking Sheet for the Implantable Defibrillator on June 23, 2004, it should be noted that it is necessary to perform ICD threshold testing for all ICD implantations ¡V both single- and dual-chamber models ¡V consisting of ventricular fibrillation conversion, at a minimum, in order to ensure that the ICD device can convert this lethal rhythm in the patient. With regard to the question posed concerning the risks and benefits of anti-tachycardia pacing function of an ICD, it should be noted that this function is performed in both dual or single-chamber model ICDs via the implanted defibrillation lead and does not require the implantation of a separate lead for this purpose. There is also considerable evidence that anti-tachycardia pacing as part of an ICD therapy regimen benefits patients whose arrhythmia clinical substrate is likely to yield ventricular tachycardia as a primary rhythm and the risk of untoward events is minimal.

St. Jude Medical appreciates the opportunity to provide additional comment regarding CMS¡¦ National Coverage Analysis of Implantable Cardioverter Defibrillators. If we can provide any further information regarding this coverage determination, please contact Susan Walker, Director of Reimbursement, at (651) 481-7638 or swalker@sjm.com.

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