FDA Approves Expansion Indication for Pacemakers, Defibrillators

The FDA approves an application from Medtronic for revised labeling of certain devices

The FDA has approved an application from Medtronic requesting revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), the FDA reports. The revised labeling expands the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

The list of devices includes:

  • Consulta CRT-P
  • Consulta CRT-D
  • Syncra CRT-P 
  • Maximo II CRT-D 
  • Concerto II CRT-D 
  • Viva XT CRT-D 
  • Viva S CRT-D 
  • Protecta CRT-D 
  • Protecta XT CRT-D 
  • Brava CRT-D 

The devices were previously approved for patients with more severe heart failure, but the new approved use allows the devices for patients with less severe heart failure who are already indicated to receive RV pacing. The CRT-P and CRT-D devices provide electrical impulses to the right and left sides of the heart through implanted leads to the heart’s right and left ventricle. A clinician programs the timing of the impulses to sync to the patient’s heart to improve cardiac function.

According to the FDA, “The expanded approval for the CRT-D and CDT-P devices was based on data from the Block HF clinical study that compared death, heart failure-related urgent care visits and increases in left ventricular end systolic volume index (LVESVI) in study subjects who received either left and right ventricular pacing, or right ventricular pacing alone. LVESVI is a diagnostic measure of cardiac structure and function. A total of 918 subjects participated in the trial, 531 of whom received a CRT-P device and 227 of whom received a CRT-D device. The study showed that the cardiac resynchronization therapy  provided by CRT-P and CRT-D devices results in a 27 percent reduction in death, heart-failure-related urgent-care visits, and increases in LVESVI compared to right ventricular pacing alone.“

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