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Edwards Lifesciences' (EW) SAPIEN TAVR Study Outcome Favorable
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Edwards Lifesciences, Inc. (EW - Free Report) presented results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. The data were published in the Journal of the American College of Cardiology (JACC), Cardiovascular Interventions.
The recent development will strengthen Edwards Lifesciences transcatheter aortic valve replacement (TAVR) and surgical structural heart business.
Study Details
In a study of real-world evidence from the TVT Registry, researchers compared the outcomes of more than 10,000 patients treated with the SAPIEN 3 Ultra RESILIA valve to those receiving SAPIEN 3 Ultra and SAPIEN 3 valves using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts.
The study discovered that all Edwards TAVR platforms achieved good PVL results. The SAPIEN 3 Ultra RESILIA valve was also associated with significantly lower echocardiography-derived mean gradients and larger effective orifice areas across all four valve sizes.
In an analysis of 8,100 propensity matched patients across more than 800 sites in the United States found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at three years.
Significance of Study Outcome
When compared to the SAPIEN 3 and SAPIEN 3 Ultra valves, a study utilizing Edwards' most recent TAVR technology, the SAPIEN 3 Ultra RESILIA valve, revealed larger effective orifice areas across all valve sizes, reduced rates of paravalvular leak (PVL) at 30 days and lower echo-derived gradients.
These real-world data demonstrate the significant improvements of the SAPIEN 3 Ultra RESILIA valve, which offers patients with severe aortic stenosis the best option for true lifetime management of their heart valve disease and contributes to the growing body of evidence on the performance of the Edwards SAPIEN TAVR.
Image Source: Zacks Investment Research
In a second study presented during the late-breaking clinical trials session, small Edwards SAPIEN TAVR valves demonstrated equally excellent outcomes at three years as compared to larger SAPIEN TAVR valve sizes. The outcome provides important insights into the actual performance of small Edwards valves and reaffirms the excellent outcomes for patients receiving SAPIEN TAVR, regardless of valve size.
Industry Prospects
Per a report by Grand View Research, the global transcatheter aortic valve replacement market size was valued at $ 5,714.3 million in 2022 and is expected to witness a CAGR of 7.2% from 2023 to 2030. The rising prevalence of aortic valve stenosis (AS), increasing demand for minimal-invasive procedures such as transcatheter aortic valve replacement and the growing geriatric population drive demand for the TAVR industry.
Progress Within TAVR Business
In the past few quarters, TAVR sales have been driven by the strong performance of the Edwards SAPIEN 3 Ultra valve in the United States, Europe and the Rest of the World, the Edwards SAPIEN 3 Ultra RESILIA valve in the United States and the Edwards SAPIEN 3 in Japan. The business closed the fourth quarter of 2023 with strong 12% year-over-year growth, driven by a broad portfolio of innovative therapies.
On the clinical side, enrollment continues to progress well in the ALLIANCE pivotal trial — designed to study the next-generation TAVR technology, SAPIEN X4. The company pursues opportunities for improving the diagnosis and treatment of many more patients who remain undertreated.
Price Performance
In the past year, EW’s shares have gained 16.3% compared with the industry’s rise of 13.4%.
Zacks Rank and Other Key Picks
Edwards Lifesciences currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the broader medical space are Stryker Corporation (SYK - Free Report) , Cencora, Inc. (COR - Free Report) and Cardinal Health (CAH - Free Report) .
Stryker, carrying a Zacks Rank #2, reported a fourth-quarter 2023 adjusted EPS of $3.46, beating the Zacks Consensus Estimate by 5.8%. Revenues of $5.8 billion outpaced the consensus estimate by 3.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker has an estimated earnings growth rate of 11.5% for 2025 compared with the S&P 500’s 9.9%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 5.1%.
Cencora, carrying a Zacks Rank #2, reported a first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.3 billion outpaced the Zacks Consensus Estimate by 5.1%.
COR has an earnings yield of 5.75% compared with the industry’s 1.85%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 6.7%.
Cardinal Health, carrying a Zacks Rank #2, reported second-quarter fiscal 2024 adjusted earnings of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion improved 11.6% on a year-over-year basis and also topped the Zacks Consensus Estimate by 1.1%.
CAH has a long-term estimated earnings growth rate of 15.3% compared with the industry’s 11.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%.
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Edwards Lifesciences' (EW) SAPIEN TAVR Study Outcome Favorable
Edwards Lifesciences, Inc. (EW - Free Report) presented results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform. The data were published in the Journal of the American College of Cardiology (JACC), Cardiovascular Interventions.
The recent development will strengthen Edwards Lifesciences transcatheter aortic valve replacement (TAVR) and surgical structural heart business.
Study Details
In a study of real-world evidence from the TVT Registry, researchers compared the outcomes of more than 10,000 patients treated with the SAPIEN 3 Ultra RESILIA valve to those receiving SAPIEN 3 Ultra and SAPIEN 3 valves using procedural and hemodynamic data and clinical outcomes for propensity-matched cohorts.
The study discovered that all Edwards TAVR platforms achieved good PVL results. The SAPIEN 3 Ultra RESILIA valve was also associated with significantly lower echocardiography-derived mean gradients and larger effective orifice areas across all four valve sizes.
In an analysis of 8,100 propensity matched patients across more than 800 sites in the United States found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at three years.
Significance of Study Outcome
When compared to the SAPIEN 3 and SAPIEN 3 Ultra valves, a study utilizing Edwards' most recent TAVR technology, the SAPIEN 3 Ultra RESILIA valve, revealed larger effective orifice areas across all valve sizes, reduced rates of paravalvular leak (PVL) at 30 days and lower echo-derived gradients.
These real-world data demonstrate the significant improvements of the SAPIEN 3 Ultra RESILIA valve, which offers patients with severe aortic stenosis the best option for true lifetime management of their heart valve disease and contributes to the growing body of evidence on the performance of the Edwards SAPIEN TAVR.
In a second study presented during the late-breaking clinical trials session, small Edwards SAPIEN TAVR valves demonstrated equally excellent outcomes at three years as compared to larger SAPIEN TAVR valve sizes. The outcome provides important insights into the actual performance of small Edwards valves and reaffirms the excellent outcomes for patients receiving SAPIEN TAVR, regardless of valve size.
Industry Prospects
Per a report by Grand View Research, the global transcatheter aortic valve replacement market size was valued at $ 5,714.3 million in 2022 and is expected to witness a CAGR of 7.2% from 2023 to 2030. The rising prevalence of aortic valve stenosis (AS), increasing demand for minimal-invasive procedures such as transcatheter aortic valve replacement and the growing geriatric population drive demand for the TAVR industry.
Progress Within TAVR Business
In the past few quarters, TAVR sales have been driven by the strong performance of the Edwards SAPIEN 3 Ultra valve in the United States, Europe and the Rest of the World, the Edwards SAPIEN 3 Ultra RESILIA valve in the United States and the Edwards SAPIEN 3 in Japan. The business closed the fourth quarter of 2023 with strong 12% year-over-year growth, driven by a broad portfolio of innovative therapies.
On the clinical side, enrollment continues to progress well in the ALLIANCE pivotal trial — designed to study the next-generation TAVR technology, SAPIEN X4. The company pursues opportunities for improving the diagnosis and treatment of many more patients who remain undertreated.
Price Performance
In the past year, EW’s shares have gained 16.3% compared with the industry’s rise of 13.4%.
Zacks Rank and Other Key Picks
Edwards Lifesciences currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the broader medical space are Stryker Corporation (SYK - Free Report) , Cencora, Inc. (COR - Free Report) and Cardinal Health (CAH - Free Report) .
Stryker, carrying a Zacks Rank #2, reported a fourth-quarter 2023 adjusted EPS of $3.46, beating the Zacks Consensus Estimate by 5.8%. Revenues of $5.8 billion outpaced the consensus estimate by 3.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stryker has an estimated earnings growth rate of 11.5% for 2025 compared with the S&P 500’s 9.9%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 5.1%.
Cencora, carrying a Zacks Rank #2, reported a first-quarter fiscal 2024 adjusted EPS of $3.28, which beat the Zacks Consensus Estimate by 14.7%. Revenues of $72.3 billion outpaced the Zacks Consensus Estimate by 5.1%.
COR has an earnings yield of 5.75% compared with the industry’s 1.85%. The company’s earnings surpassed estimates in each of the trailing four quarters, the average being 6.7%.
Cardinal Health, carrying a Zacks Rank #2, reported second-quarter fiscal 2024 adjusted earnings of $1.82, which beat the Zacks Consensus Estimate by 16.7%. Revenues of $57.45 billion improved 11.6% on a year-over-year basis and also topped the Zacks Consensus Estimate by 1.1%.
CAH has a long-term estimated earnings growth rate of 15.3% compared with the industry’s 11.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 15.6%.