Medtronic has announced that the US Food and Drug Administration (FDA) advisory panel has voted in favour of expanding indication for all Medtronic's cleared cardiac resynchronisation therapy pacemakers and defibrillators (CRT-P and CRT-D).
The circulatory system devices panel of the FDA's medical devices advisory committee voted four to three, with one abstention, that the benefits of programming patients for bi-ventricular pacing using Medtronic pulse generators outweighed the risks.
The panel's favourable recommendation is based on data from the landmark BLOCK HF (Biventricular versus right ventricular pacing in patients with left ventricular dysfunction and atrioventricular block) clinical trial, a prospective, multi-centre, randomised, double-blind, controlled trial that evaluated patients with AV block and LV dysfunction (ejection fraction less than or equal to 50%), NYHA Class I, II or III, and who met standard indications for ventricular pacing.
FDA panelists were unanimous that these devices were effective when programmed for bi-ventricular pacing, and voted six to one that they are safe.
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.
Medtronic cardiac rhythm disease management business medical director Dr David Steinhaus said 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 said.
The expanded indication was supported by Medtronic's BLOCK HF trial, which showed a 27% relative risk reduction in the composite study endpoint of death, healthcare utilisation visits requiring IV heart failure therapy, and significant increase in left ventricular end systolic volume index (LVESVI, a measure of cardiac structure), as well as improvements in both cardiac function and quality of life.
University at Buffalo School of Medicine and Biomedical Sciences BLOCK HF lead investigator Dr Anne Curtis said the results of BLOCK HF offer a potential new treatment solution for heart failure patients with AV block.
"This new approach could fill an unmet need for these patients," Dr Curtis said.
Image: The VivaXT CRT-D. Photo: courtesy of Medtronic, Inc.