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Advisory panel backs expanded indications for CRT-D devices
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The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee today voted and recommended approval of expanded indications for all commercially available Medtronic cardiac resynchronization therapy defibrillator devices in patients with milder symptoms.
Advisory members voted 5-0 that the Medtronic Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are safe for HF patients with NYHA Class II. The device expansion request would also include patients who remain symptomatic despite stable, optimal medical therapy and who have left bundle branch block with a QRS duration of ≥120 ms and LV ejection fraction of ≤30%, according to a press release from Medtronic.
The panel also voted 3-2 that the device is effective and 3-2 that the benefits of the devices outweigh risks in this patient population.
Although the panel recommended expanded indications overall, some expressed concerns about using the device in these patients. David Naftel, PhD, of the University of Alabama at Birmingham, said, “I wish it were a slam dunk. I don’t believe it is, but I do believe that the totality of the evidence supports approval.”
Much of the discussion focused on results of the REVERSE and RAFT trials. One issue cited by the committee is that the QRS duration was not high enough in these studies.
“Had the [QRS] criteria been 150 ms it would’ve been a yes [vote for me],” Richard A. Lange, MD, of the University of Texas, said during the meeting.
Michael A. Ferguson, MD, CAPT, USN, MC, of the National Naval Medical Center, also questioned optimal QRS duration. “I don’t think [QRS duration] was established with the data that we were presented with today, which was my only reason for voting no.”
Already approved by the FDA in June 2002, the Medtronic CRT-D devices are indicated for patients with NYHA Class III or IV who remain symptomatic despite stable, optimal medical therapy, have LV ejection fraction of ≤35% and have a prolonged QRS duration.
Although the FDA is not required to follow the recommendations of the advisory committees, it usually does. - by Casey Murphy
Disclosure: No relevant financial disclosures were reported by the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee members.
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