The US Food and Drug Administration (FDA) advisory panel has recommended the expanded indication of Medtronic’s cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D) for the treatment of patients who suffer from an abnormal heart rhythm called atrioventricular block.
The circulatory systems devices advisory panel voted to recommend the company's devices based on strong safety and efficacy profiles from the landmark BLOCK HF clinical trial.
In the BLOCK HF clinical trial, the BiV pacing demonstrated improvements in both cardiac function and quality of life, and a 27% 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.
Medtronic requested the FDA to expand treatment indications for its CRT-P and CRT-D devices based on the results from the clinical study and the FDA will now review the company's request based on the panel's feedback.
Medtronic Cardiac Rhythm Disease Management business medical director and Heart Failure vice president and general manager Dr David Steinhaus noted as the longest running trial of its kind, BLOCK HF has shown superior long-term outcomes of BiV pacing for these patients.
"As the regulatory process continues, we look forward to working with the FDA to expand the use of our CRT devices to treat this specific patient population," Dr Steinhaus added.
