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. (NYSE: MDT) devices is beneficial fortreating 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 intreating this specific patient population (Yes: 4 votes; No: 3 votes; Abstain:1 vote). The panel's favorable recommendation is based on data from thelandmark BLOCK HF clinical trial, which used Medtronic cardiacresynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D).Most patients with AV block are currently indicated to receive conventionalright ventricular (RV) pacing via a single or dual chamber pacemaker orimplantable cardioverter-defibrillator (ICD). However, in the BLOCK HFclinical 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 thispatient group based on the technology's strong safety (Yes: 6 votes, No: 1votes) and efficacy (Yes: 7 votes, No: 0 votes) profiles. The FDA now willconsider the panel's feedback as it reviews the request from Medtronic toexpand treatment indications for its CRT-P and CRT-D devices to include NewYork Heart Association (NYHA) Class I, II and III heart failure, patients withpacemaker-indicated second or third degree AV block, or first degree AV blockwhere a requiment for a high percentage of ventricular pacing is clear, and LVejection fraction less than or equal to 50 percent.