- Abbott reported a successful clinical trial of its dual-chamber leadless pacemaker, giving it a new angle to pursue as it tries to wrestle market share from Medtronic.
- While safety problems slowed Abbott’s development of the leadless pacemaker, allowing Medtronic to dominate the market, it received approval for a single-chamber device last year and has now submitted data from the first large clinical trial of a dual-chamber product.
- Abbott reported the data at the Heart Rhythm Society's 44th annual meeting in New Orleans, an event where Boston Scientific shared pulsed field ablation and cryoablation data and Medtronic published pivotal results on its extravascular implantable cardioverter defibrillator (ICD).
Medtronic was the only manufacturer of a leadless pacemaker in the U.S. market in the years after it won approval for its Micra device in 2016. While leadless pacemakers were designed to prevent lead- and pocket-related complications, a part detached from Abbott’s Nanostim device, Abbott’s first attempt at the design, and slowed development. Abbott went on to win approval for a device, Aveir VR, last year.
As a single-chamber device, Aveir VR competes directly with Medtronic’s Micra. The device tested in the clinical trial that reported results over the weekend is differentiated from Medtronic’s product. Aveir DR is made of two leadless pacemakers, one for the right atrium and another for the right ventricle. The right ventricle device is physically identical to Aveir VR.
Unlike its sibling and Medtronic’s rival, Aveir DR supports atrial pacing and in theory may provide more consistent coordination of the contraction of the atria and ventricles of the heart. Abbott put the device to the test in a single-arm study of 300 patients, details of which were reported in The New England Journal of Medicine.
Abbott looked at one primary safety endpoint, freedom from complications at 90 days, and two primary efficacy endpoints, a combination of adequate atrial capture threshold and sensing amplitude at three months and the proportion of patients with at least 70% atrioventricular synchrony at three months. The study met the threshold of success for all three endpoints. Abbott has filed for approval in the U.S.
Approval of Aveir DR would provide an additional challenge to Medtronic, which used the same event to share data on one of its heart devices. Medtronic said the device, EV ICD, is a first-of-its-kind implantable defibrillator with a lead placed under the breastbone rather than in the heart and veins. The design is intended to avoid risks associated with traditional, transvenous ICDs.
In the clinical trial of 299 implanted patients, an estimated 6.8% of patients experienced appropriate therapy by 18 months. Nineteen patients experienced 80 spontaneous, appropriately treated arrhythmic episodes. The findings build on an earlier study that showed the Medtronic ICD had 98.7% defibrillation effectiveness results at implant.
Boston Scientific, which competes with Abbott and Medtronic for the ICD market, used the heart rhythm event to share additional real-world outcomes on its Farapulse pulsed field ablation device and results from a clinical trial of its POLARx cryoablation system.