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The approval of cardiac resynchronization pacemakers and defibrillators manufactured by Medtronic has been expanded to include patients with atrioventricular block and less severe heart failure, the Food and Drug Administration announced on April 10.
The approval applies to two cardiac resynchronization pacemakers (CRT-Ps) and eight cardiac resynchronization defibrillators (CRT-Ds), and was based on the results of the BLOCK-HF study, according to the FDA statement.
The use of these devices "can delay the occurrence of heart failure–related urgent care visits for people who meet these new criteria," Christy Foreman, director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said in the statement.
Previously, Medtronic CRT devices were approved for patients with moderate to severe heart failure (New York Heart Association class III and IV), and in April 2012, the FDA approved an expanded indication for Medtronic’s CRT-Ds to treat certain mildly symptomatic heart failure patients – before the addition of patients with atrioventricular block. The expanded approval includes patients with AV block and left ventricular systolic dysfunction, and allows patients with NYHA class I, II, and III with AV block and an ejection fraction of 50% or less to receive biventricular pacing with these devices, according to the Medtronic press release announcing the approval.
In the BLOCK-HF trial of 918 patients with an indication for pacing with AV block, NYHA class I, II, or III heart failure, and a left ventricular ejection fraction of 50% or less, patients were randomized to treatment with right ventricular or biventricular pacing. Those who required defibrillation therapy received an implantable cardioverter-defibrillator, and the others received a cardiac resynchronization pacemaker. Over an average of about 3 years, those in the biventricular pacing group showed a highly significant 26% reduction in risk of a composite of all-cause mortality, an urgent care visit for heart failure requiring intravenous therapy, or a 15% or greater increase in the left ventricular end-systolic volume index (the primary endpoint), compared with patients who had right ventricular pacing (N. Engl. J. Med. 2013;368:1585-93).
The 10 devices are the Consulta CRT-P, Consulta CRT-D, Syncra CRT-P, Maximo II CRT-D, Concerto II CRT-D, Viva XT CRT-D, Viva S CRT-D, Protecta CRT-D, Protecta XT CRT-D, and Brava CRT-D.
