Devices & Diagnostics

FDA advisory panel recommends Medtronic expand CRT device indication to treat patients with AV block, reduced heart function

In a tight vote Tuesday, a U.S. Food and Drug Administration Circulatory Systems Device Advisory […]

In a tight vote Tuesday, a U.S. Food and Drug Administration Circulatory Systems Device Advisory Panel recommended Medtronic‘s (MDT) CRT devices are beneficial for biventricular pacing when treating patients with atrioventricular block and left ventricular systolic dysfunction. The vote that the overall benefits outweigh potential risks–four recommend, three no and one abstain–was based on clinical trial data using the medical device company’s cardiac re-synchronization therapy-pacemakers and -defibrillators (CRT-Ps and CRT-Ds). All seven voting panelists voted yes, the device was efficacious in this expansion and six of the seven voted yes for its safety. (Medtronic CRT devices are not currently approved in the United States for patients with AV block with left ventricular dysfunction.)

Typically, patients with AV block are treated with right ventricular pacing with a pacemaker or ICD. The biventricular pacing showed a 27 percent relative risk reduction regarding “death, healthcare utilization visits requiring IV heart failure therapy and significant increase in left ventricular end systolic volume index,” according to a press release.

Also from Medtronic:

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 requirement for a high percentage of ventricular pacing is clear, and LV ejection fraction less than or equal to 50 percent.

 

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