Medtronic (NYSE:MDT) late last week released data from a new clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore atrioventricular synchrony and improve cardiac function in patients with sinus rhythm and AV block.
Results from the study were presented at the Heart Rhythm Society’s annual scientific sessions in Boston, the Fridley, Minn.-based company said.
Researchers in the Marvel study examined the use of the algorithm, which uses the Mira pacer’s accelerometer signal, in 64 patients, Medtronic said. Investigators aimed to evaluate whether the accelerometer could be used to monitor for contractions in the atrium, even though the device was implanted in the ventricle, and its ability to pace the ventricle to contract in sequence with the atrium.
Data from the study indicated that the percentage of AV beats in synchrony during pacing with the AV algorithm was 87% across all study patients, 80% in high-degree AV block patients and 94.5% in patients with predominantly intact AV conduction during the study.
For patients with high-degree AV block who could benefit the most from AV synchrony, Medtronic said that the algorithm produces significantly greater AV synchrony compared to VVI pacing with the algorithm. AV block patients also reported statistically significant improvements in stroke volume during AV algorithm pacing.
“The results of Marvel indicate that this novel mechanical sensor may allow more patients to benefit from a miniaturized leadless pacemaker. Although single-chamber pacing in the ventricle is quite safe for these patients, the preferred option is to treat them with a wired pacemaker in two chambers to maintain synchrony and cardiac function. However, patients with these traditional pacemakers are at risk of experiencing complications related to the pocket and the leads, and leadless pacemakers remove these risks,” Marvel study principal investigator Dr. Larry Chinitz of NYU Langone’s Heart Rhythm Center said in a press release.
Medtronic’s Micra pacemaker is approximately 1/10th the size of a conventional pacemaker, and is designed to be implanted via catheter into the right ventricle to deliver single-chamber pacing. The system features a battery with an estimated 12-year battery lifespan, and is cleared for use with full-body MRI scans. The FDA approved Micra in April 2016.
“We are encouraged by the results of Marvel, which support our commitment to extending the benefits of Micra TPS to broader patient groups. We are investing in additional clinical studies to confirm this accelerometer-based leadless pacing approach will benefit patients with AV block who make up approximately 40% of the pacemaker population worldwide,” cardiac rhythm and heart failure division chief medical officer Dr. Rob Kowal said in a press release.
Last week, Medtronic released one-year results from the post-approval registry study of its Micra leadless transcatheter pacing system, touting a high implant success rate and a low complication rate.