Medtronic plc reported positive interim results on the first 171 patients implanted with Evolut transaortic valve replacement (TAVR) devices in its OPTIMIZE PRO clinical trial. The postmarket, prospective, multicenter study is assessing procedural outcomes, including pacemaker rate, associated with in-procedure techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.

The history of TAVR devices is evolutionary as much as it is revolutionary, or that is at least the take-away from an Oct. 15 virtual session comparing the Acurate Neo device by Boston Scientific Corp., of Marlborough, Mass., with the Corevalve Evolut R by Dublin-based Medtronic plc.

Medtronic plc management put an emphasis on being nimble and commercializing novel technology at its investor day this week, and analysts appeared to approve of the message. As Wells Fargo’s Larry Biegelsen noted, Dublin-based Medtronic is moving away from a centralized company that is focused on economic value and margin expansion to one that is more decentralized, emphasizing innovation and topline growth.

Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. One study will pit the self-expanding Evolut Pro and Pro+TAVR systems against Edwards Lifesciences Corp.’s balloon-expandable Sapien 3 and Sapien 3 Ultra transcatheter heart valves in small annulus patients.

Results of a study presented at the American College of Cardiology's Annual Scientific Session on March 29 demonstrated “excellent” outcomes following transcatheter aortic valve replacement (TAVR) using the Medtronic plc Evolut in low surgical risk patients with bicuspid aortic valve stenosis.