The Food and Drug Administration has cleared Medtronic’s pacing lead for use in the stimulation of the bundle of His, being marketed as a new treatment option as an alternative to right ventricular pacing of the heart.
The world's biggest medical device company said studies suggest His bundle pacing may achieve better outcomes in some patients than the conventional approach to pacemaker lead placement.
Medtronic is the first company to bring a His bundle pacing lead to market in the U.S.
Physicians settled on the right ventricle as the preferred site for lead placement early in the history of the pacemaker. For many patients with cardiac conditions, right ventricular pacing is safe and effective. However, in recent years evidence of complications associated with the approach has accrued. Researchers have linked long-term right ventricular pacing to a higher risk of a range of adverse events, including heart failure and death.
Reports of these events have fueled interest in alternative pacing sites, including the His‐Purkinje conduction system. Pacing the His bundle sends impulses quickly across the right and left ventricles, ensuring they contract in unison. Physicians first explored His bundle pacing decades ago but the idea has come of age recently as the search for alternative pacing sites has intensified.
Medtronic has followed the trend, leading it to file to expand the label for its SelectSecure cardiac pacing lead. The lead received premarket approval from the FDA 15 years ago but had a label that limited its use to pacing of the right ventricle or atrium. Now, the FDA has signed off on an expanded label that allows physicians to use the lead to pace the His bundle.
The label expansion marks the first time the FDA has cleared a lead for use in His bundle pacing. That gives Medtronic first-mover advantage in a field that has delivered eye-catching but preliminary data. Last year, a clinical trial of 52 heart failure patients linked His bundle pacing to larger, more consistent improvements in left ventricle function than are typically achieved by right ventricle pacing. However, a larger trial with a control arm is needed to confirm the finding.
Medtronic is involved in research to drive the field forward, including a 70-patient clinical trial that is assessing the rate of implant success in His bundle pacing.