Medtronic Says FDA Panel Recommending Expanded Indication for Co.'s CRT Devices in Patients with AV Block, Reduced Heart Function

The U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices Advisory Panel today voted that biventricular (BiV) pacing with Medtronic, Inc.

devices is beneficial for treating patients who have atrioventricular (AV) block and left ventricular (LV) systolic dysfunction, compared to conventional right ventricular pacing. The panel voted that the overall clinical benefits outweigh the risks in treating this specific patient population (Yes: 4 votes; No: 3 votes; Abstain: 1 vote). The panel's favorable recommendation is based on data from the landmark BLOCK HF clinical trial, which used Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D). Most patients with AV block are currently indicated to receive conventional right ventricular (RV) pacing via a single or dual chamber pacemaker or implantable cardioverter-defibrillator (ICD). However, in the BLOCK HF clinical trial, BiV pacing showed: o a 27 percent relative risk reduction in the composite study endpoint of death, healthcare utilization visits requiring IV heart failure therapy, and significant increase in left ventricular end systolic volume index (LVESVI, a measure of cardiac structure); and o improvements in both cardiac function and quality of life. The advisory panel voted in favor of Medtronic CRT-P and CRT-D devices in this patient group based on the technology's strong safety (Yes: 6 votes, No: 1 votes) and efficacy (Yes: 7 votes, No: 0 votes) profiles. The FDA now will consider the panel's feedback as it reviews the request from Medtronic to expand treatment indications for its CRT-P and CRT-D devices to include New York Heart Association (NYHA) Class I, II and III heart failure, patients with pacemaker-indicated second or third degree AV block, or first degree AV block where a requiment for a high percentage of ventricular pacing is clear, and LV ejection fraction less than or equal to 50 percent.