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