FDA has cleared Medtronic's SelectSite C304-HIS deflectable catheter system for use in His-bundle pacing (HBP) procedures.
The shortcomings of right ventricular pacing, which is linked to negative outcomes such as impaired myocardial perfusion, have driven interest in targeting the His bundle. Yet, the anatomic location of the bundle can make lead placement challenging.
Medtronic's catheter system seeks to address these challenges by giving physicians more maneuverability and an adjustable form.
The right ventricle has been the go-to site for pacemaker placement since the 1950s but there are now decades of research on the risks associated with this approach. Notably, it can cause a difference in the timing of contractions in the heart, leading to adverse outcomes such as mitral and tricuspid regurgitation and a heightened risk of atrial fibrillation.
Interest in the His bundle as a pacing site goes back to the 1960s and has grown with the accumulation of evidence of its electrophysiological role in atrioventricular conduction. As HBP acts on both ventricles, it may be less prone to the timing differences that affect other pacing sites.
Medtronic responded to growing interest in HBP by securing FDA clearance to use its SelectSecure MRI SureScan Model 3830 cardiac pacing lead in the His bundle last year. The decision marked the first time FDA had cleared a pacing lead for use in HBP procedures.
The pacing lead is only one part of the package needed to perform HBP procedures. Physicians also need a means to get the lead to the pacing location. In HBP procedures, this task is complicated by the anatomic location of the His bundle and the cardiac structures surrounding it.
Physicians often use Medtronic's C315 His for the procedure but this device can be challenged by nonstandard anatomy. Medtronic developed the SelectSite C304-HIS system for use in such patients.
The catheter system has a deflectable, out-of-plane curve tailored to the path physicians take to the His bundle, plus features Medtronic claims make it more maneuverable, improve fixation and increase implant success. The device can be adapted to patients with large right atriums.
Medtronic hasn't yet released clinical data to support its claims. FDA granted 510(k) clearance to the device on the strength of nonclinical data showing it is equivalent to predicate devices, such as other C304 deflectable catheter systems.