Medtronic plc MDT recently unveiled two-year Small Annuli Randomized to Evolut or SAPIEN (“SMART”) Trial results at the Cardiovascular Research Technologies (“CRT”) 2025 conference in Washington, D.C. SMART trial is the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement ("TAVR"), conducted in patients with aortic stenosis ("AS") and a small aortic annulus.
The two-year results highlighted the continued superior performance of the Evolut TAVR valve in patients with a small aortic annulus. These results will be followed to assess long-term outcomes.
On Friday, the share price of MDT moved north 0.01% to $94.51. The latest development is likely to boost the company’s Structural Heart business within the Cardiovascular portfolio. Per the latest update, the Evolut FX+ TAVR system is seeing strong uptake in the United States, with international expansion progressing well. With favorable trial results, Medtronic’s development efforts position it well to capitalize on this opportunity. We expect market sentiment toward MDT stock to continue to remain positive surrounding this news.
Medtronic boasts a market capitalization of $121.20 billion. It delivered an average earnings surprise of 1.75% in the trailing four quarters.
The SMART two-year data demonstrated that Evolut TAVR continues to show significantly less bioprosthetic valve dysfunction ("BVD"), which can be a predictor of adverse outcomes compared to SAPIEN TAVR. Additionally, Evolut TAVR showed five times less prosthetic valve thrombosis and nine times less hemodynamic structural valve dysfunction compared to SAPIEN TAVR. These results are built on additional data of Evolut BVD performance in small and large annulus patients.
The SMART Trial is an international, prospective, multi-center, randomized post-market trial comparing the safety and performance of Evolut self-expanding TAVR versus SAPIEN balloon-expandable TAVR in patients with symptomatic severe AS and small aortic annulus. The trial, the largest head-to-head randomized control trial to primarily enroll women, randomized and treated 716 patients, 87% of whom were women, across more than 80 sites worldwide. Patients enrolled in the trial will continue to be followed out to five years.
Per a report by Grand View Research, the global transcatheter aortic valve replacement market size is projected to witness a compound annual growth rate (“CAGR”) of 6.6% from 2025 to 2030. Factors driving the demand for TAVR include the rising prevalence of AS, increasing preference for minimally invasive procedures and the growing geriatric population.
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The previous month, Medtronic received FDA approval for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI) for people diagnosed with Parkinson's disease. The FDA approval came soon after the company received CE mark approval in the European Union (EU) and the United Kingdom (UK) in January.
In the past three months, MDT’s shares have risen 10.6% compared with the industry’s 10.4% growth.
Medtronic currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Masimo MASI, Boston Scientific BSX and Cardinal Health CAH. At present, Masimo sports a Zacks Rank #1 (Strong Buy), whereas Boston Scientific and Cardinal Health carry a Zacks Rank #2 (Buy) each.
Masimo’s shares have rallied 35% in the past year. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for MASI’s 2024 earnings per share (EPS) have increased 1.2% to $4.10 in the past 30 days. MASI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.1%. In the last reported quarter, it posted an earnings surprise of 16.6%.
Estimates for Boston Scientific’s 2025 EPS have jumped 2.9% to $2.85 in the past 30 days. Shares of the company have surged 49.9% in the past year compared with the industry’s growth of 10.4%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.25%. In the last reported quarter, it delivered an earnings surprise of 7.69%.
Estimates for Cardinal Health’s fiscal 2025 EPS have increased 1.5% to $7.94 in the past 30 days. Shares of the company have jumped 9.6% in the past year against the industry’s 2.8% decline. CAH’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 9.6%. In the last reported quarter, it delivered an earnings surprise of 10.3%.
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