Medtronic CRT Devices Now Approved to Treat Patients with AV Block and Reduced Heart Function

Landmark BLOCK HF trial demonstrates clinical benefits of biventricular pacing in new patient population


April 17, 2014

Medtronic offers an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D). Medtronic CRT devices are approved to treat patients with atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, reducing heart failure hospitalizations and mortality, and improving cardiac function in these patients.

The expanded indication allows patients designated as New York Heart Association (NYHA) Class I, II and III with AV block that are expected to require a high percentage of ventricular pacing, and who have an ejection fraction (EF) less than or equal to 50 percent, to receive BiV pacing via Medtronic CRT devices.

The FDA's approval was based on the landmark BLOCK HF clinical trial, which demonstrated significant clinical advantages of BiV pacing compared with traditional right ventricular (RV) pacing in this patient population, including a 27 percent relative risk reduction in the composite study endpoint of heart size, heart failure hospitalizations and mortality.

More than 1 million Americans have AV block, which reduces the heart's ability to properly function by blocking the electrical signals between its top and bottom chambers. Symptoms of the condition are fainting, dizziness and shortness of breath. A debilitating and often deadly disease, heart failure will cost the United States an estimated $32 billion in 2013, with projections showing a 120 percent increase in cost by 2030 for a total of $70 billion.

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