Medtronic has initiated a head-to-head postmarket trial to compare its transcatheter aortic valve replacement system to Edwards Lifesciences’ rival device.
The study, which Medtronic disclosed Wednesday, will randomize around 700 patients with small annuli for treatment with self-expanding Evolut PRO devices or Edwards’ Sapien 3 line of balloon-expandable devices. Medtronic chose a patient population where it may have an edge; physicians writing in JAMA Cardiology last month said the supra-annular design of Medtronic’s TAVR system may be better suited to patients with small annuli.
Separately, Medtronic released details of a plan to potentially acquire a startup that's running an early feasibility study of a transcatheter mitral valve repair technology, which could position it to compete with Abbott's MitraClip.
Head-to-head comparisons of TAVR devices are rare. Boston Scientific pitted its TAVR devices against rival systems from Edwards and Medtronic as part of its effort to establish a foothold in the market. Additionally, a German hospital funded a head-to-head comparison of Edwards and Medtronic’s earlier-generation TAVR devices. Those studies were the only head-to-head trials identified in a recent JAMA Cardiology review.
Medtronic is now working to add another study to the short list of head-to-head comparisons. The postmarket trial will assess the safety and performance of Medtronic’s Evolut Pro and Pro+ and Edwards’ Sapien 3 and Sapien 3 Ultra.
Enrollment is limited to patients with small annuli and candidates for procedures in which a surgeon implants a transcatheter valve inside a failed surgical valve. Medtronic estimates those two groups account for more than 40% of the global TAVR market, suggesting a clear win for the Evolut system could strengthen the company’s pitch for a significant slice of the fast-growing sector.
There are reasons to think Medtronic has a shot at showing Evolut has an edge in the target patient population. Medtronic’s TAVR system is the only FDA-approved supra-annular valve technology. The supra-annular design means the valve leaflets are above the native annulus. Intra-annular valves are completely housed within the native annulus.
Cardiologists have posited that supra-annular devices may work better in small annuli because they could provide better hemodynamics and avoid severe prosthesis-patient mismatch. However, there is a lack of head-to-head data to support that hypothesis. Henry Ford Health System is working on a trial to generate such data but the Medtronic study is bigger and therefore could be more conclusive.
Investigators will start enrolling subjects in Medtronic’s trial early next year. The trial will evaluate whether Evolut enables better blood flow and is non-inferior to Sapien 3 in terms of mortality, stroke or rehospitalization at 12 months.
Medtronic disclosed details of the study alongside other updates in its cardiovascular business. A clinical trial to assess Evolut in patients with symptomatic moderate and asymptomatic severe aortic stenosis is in the works. Such patients are ineligible for TAVR under current guidelines and indications for use.
Also Wednesday, Medtronic shared details of its partnership with medical device incubator The Foundry. Medtronic said it has worked with the incubator since 2017 to create a transcatheter mitral repair startup. The startup, Half Moon Medical, has now received FDA approval to run an early feasibility study. Medtronic has an option to acquire Half Moon Medical. If Medtronic exercises that option, it may eventually challenge Abbott’s MitraClip for a fast-growing market.