It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?

Roughly a decade has passed since the FDA first approved a transcatheter aortic valve replacement (TAVR) device, but the U.S. market has proven difficult to access for more than a small number of manufacturers. Abbott Laboratories, of Abbott Park, Ill., is now a player in the market with the FDA’s approval of the Portico device, a product that was first implanted in a human subject in 2011, a clear demonstration of the difficulty of moving these devices from research and development to the market.

The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022.

Keystone Heart Ltd. had the unusual experience of being the sponsor of a rare class II device appearance before an FDA advisory committee, which considered whether the company’s Triguard 3 device was substantially equivalent (SE) to a predicate device. However, the company’s bid for an SE result was unsuccessful, likely leaving Keystone with a considerable additional regulatory lift before the company can get to market.

Boston Scientific Corp. presented late-breaking data at EuroPCR 2021 demonstrating positive procedural performance for its Acurate Neo2 aortic valve system, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI). The findings are good news, following the older Acurate Neo’s failure to demonstrate noninferiority to Medtronic plc’s Evolut R in the so-called SCOPE II study.

Two-year results from the Evolut Low Risk Trial show Medtronic plc’s Evolut transcatheter aortic valve replacement (TAVR) is noninferior to open-heart surgery in younger, healthier aortic stenosis patients. Moreover, the Evolut cohort fared better on certain critical events. Specifically, two-year rates of all-cause mortality or disabling stroke were 4.3% for TAVR patients vs. 6.3% for those undergoing surgical aortic valve repair (SAVR).

Much of the noise surrounding transcatheter aortic valve replacement (TAVR) vs. its surgical counterpart has to do with residual paravalvular leak. However, a new paper in the Journal of the American College of Cardiology (JACC) seems to have overwritten that consideration. The underlying registry study indicates that procedural success and outcomes at one year are superior in TAVR to in SAVR – yet another piece of evidence that seemingly tips the scales even more toward TAVR devices.

Edwards Lifesciences Corp. held its 2020 virtual investor conference Dec. 10, providing details on its 2021 financial outlook. The company is projecting global mid-teen sales growth totaling $4.9 billion to $5.3 billion and a return to double-digit sales growth in its transcatheter aortic valve replacement (TAVR) business. Earnings per share (EPS) guidance for the coming year is $2-2.20, below the consensus estimate of $2.21, due to investments in R&D and sales to fuel future growth.

Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.

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.