Edwards Isn’t Sweating the SMART Results

Results from the SMART study rocked the transcatheter aortic valve replacement (TAVR) landscape earlier this month. The trial caused controversy because it demonstrated that Medtronic’s Evolut Platform outperformed Edwards Sapien valve.

Results from the trial were presented at the American College of Cardiology’s annual scientific session.

More specifically, one-year results of the SMART trial with small aortic annuli (SAA) demonstrated non-inferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut TAVR platform compared to the SAPIEN platform.

During a recent earnings call, Edwards executives discussed what the trial could mean for the company going forward. Larry Wood, Group President of TAVR and Structural Heart for Edwards spoke about the trial noting that the results did not diminish what the company was doing or had done in TAVR.

“I think it's just a reminder, and we've talked about this before, but the decision on what valve to use is multifactorial,” Wood said according to a Seeking Alpha transcript. “It's never been about one criterion. It's never been about one data point. And so, we continue to have confidence in our platform and the value proposition, and with our Ultra RESILIA technology and all the other things that we're doing that we always model in competition, but we feel very good about our platform and our leadership.”

Bernard Zovighian, Edwards’ CEO also highlighted the company's success as a defense against the results.

“In the last 10 years, we signed 12,000 symptomatic severe aortic patients across mainly FDA-approved studies, Zovighian said according to a Seeking Alpha transcript. “And today, again, we are the only company conducting groundbreaking research into the treatment of AS through early TAVR in progress."

Edwards posted 1Q24 results that exceeded Wall Street expectations. The company increased its revenue guidance. The sales result came in near the top end of the $1.53 billion-$1.61 billion guidance range and at the high end of the $0.62-$0.66 adj. EPS range. 

Marie Thibault, an analyst with BTIG wrote, “We see much to look forward to, including the ongoing Evoque launch and new clinical trial data later this year that may open up the asymptomatic AS market.”