Analysts have been looking forward to the SURTAVI trial results in anticipation that the data could also be a catalyst for Medtronic's rival in the TAVR space, Edwards Lifesciences, which was MD+DI's 2016 Medtech Company of the Year.
Rick Wise, of Stifel, noted in a March 3, 2017 report that positive SURTAVI results could be a catalyst for Edwards, and would possibly accelerate adoption of TAVR in the intermediate risk category. Edwards is currently the only TAVR player with FDA approval for IR patients.
Edwards could also try to use Medtronic's data as marketing leverage because Sapien 3 proved to be superior to open surgery in the PARTNER 2A trial, and Medtronic's TAVR devices were only considered non-inferior to SAVR in the SURTAVI trial. Medtronic would probably counter that argument though, Biegelsen said, on account that Edwards’ data was a propensity matched analysis, not a true randomized control trial.
Edwards' data beat Medtronic's data both in terms of moderate-to-severe paravalvular leak (PVL) complications, and post-procedural pacemaker rates. In the SURTAVI trial, the moderate-to-severe PVL rate in the TAVR arm was 5.3% at one year, compared to the 1.5% rate for Sapien 3 patients in the PARTNER 2A trial. Biegelsen said Medtronic’s Evolut Pro, which is on track to hit the U.S. market later this year, should help reduce the PVL rate. The SURTAVI data also showed that 25.9% of patients in the TAVR arm needed a pacemaker implanted soon after the procedure, whereas only 12.4% of Sapien 3 patients in the PARTNER 2A trial needed a pacemaker implanted.
Post-TAVR pacemaker rates have been an adoption barrier, because the potential cost of a pacemaker has to be factored into the total cost of TAVR versus the cost of open surgery. It's possible that this trend will start to shift, however, as better temporary pacing leads hit the market and offer an alternative to permanent pacemaker implantation for TAVR patients.
[Image credit: EDWARDS LIFESCIENCES]