Minnesota medical device maker Medtronic (NYSE:MDT) has a date with the FDA, during which time it hopes to convince the agency’s Circulatory System Devices Panel to update labeling for all of the company’s implantable pacemakers and defibrillators.
Medtronic wants to update its labeling to recommend bi-ventricular pacing, in which implanted leads thread from the pulse generator to both the left and right ventricles of the heart.
The recommendation is based on findings from Medtronic’s BLOCK HF clinical trial, which suggests that patients who receive bi-ventricular pacing, rather than right-side pacing alone, had a "significant’ increase in left ventricular end systolic volume index, according to a notice in the Federal Register. Medtronic will meet with FDA regulators on October 8.
