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FDA Recommends Expanded Indication For Boston Scientific Heart Failure Devices

Boston Scientific, a developer, manufacturer and marketer of interventional medical devices, has reported that the Circulatory System Devices Panel of the FDA has unanimously recommended approval of an expanded indication for its cardiac resynchronization therapy defibrillators (CRT-Ds), including the COGNIS CRT-D.

The panel has recommended the expansion which include the majority of the studied population of the landmark Multicenter Automatic Defibrillator Implantation Trial-cardiac resynchronization therapy (MADIT-CRT) clinical trial, which evaluated the ability of the devices to slow the progression of heart failure in patients with asymptomatic or mild heart failure.

In response to a request from the FDA, Boston Scientific has worked with the MADIT-CRT Executive Committee to perform an extensive subgroup analysis of the trial data. The subgroup analysis showed that a simple finding on an electrocardiogram of Left bundle branch block (LBBB) was the baseline characteristic in the trial to predict which asymptomatic or mild heart failure patients were likely to benefit from a CRT-D.

Results of the MADIT-CRT trial were published in the October 2009 issue of the New England Journal of Medicine. The primary endpoint showed that Boston’s CRT-Ds were associated with a 34% relative reduction in the risk of all-cause mortality or first heart failure event in asymptomatic and mild heart failure patients, when compared to standard implantable cardioverter defibrillators (ICDs).

In addition, data presented to the panel demonstrated that CRT-Ds reduced the relative risk of heart failure events by 42% when compared to ICD therapy. MADIT-CRT is the randomized study of NYHA Class I and II patients, with more than 1,800 patients enrolled at 110 centers worldwide.

Hank Kucheman, executive vice president and group president of cardiology, rhythm and vascular division at Boston Scientific, said: “Boston Scientific welcomes the panel’s decision to recommend expanding the current indication to include the majority of the MADIT-CRT population. If an expanded indication is approved by the FDA, many additional heart failure patients would be eligible for this therapy, which has been clinically proved to slow the progression of this severe and life-limiting condition.”