Medtronic ‘encouraged’ by transcatheter pacing study results

Medtronic announced new clinical study results demonstrating that an investigational algorithm, utilizing the accelerometer signal in the Micra Transcatheter Pacing System may restore AV synchrony, improving cardiac function in patients with sinus rhythm and atrioventricular block. The results from the MARVEL feasibility study were presented today during a late-breaking session at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions, and simultaneously published in Heart Rhythm. “The results of MARVEL indicate that this novel mechanical sensor may allow more patients to benefit from a miniaturized leadless pacemaker,” said Larry Chinitz, M.D., MARVEL study principal investigator and cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center in New York City. “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.” “We are encouraged by the results of MARVEL, which support our commitment to extending the benefits of Micra TPS to broader patient groups,” said Rob Kowal, M.D., Ph.D., vice president and chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. “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 percent of the pacemaker population worldwide.”

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