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EW Stock to Benefit From Favorable RHEIA Trial Data on TAVI

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At the European Society of Cardiology Congress 2024, Edwards Lifesciences (EW - Free Report) announced the results from the RHEIA Trial — the first-ever study focused exclusively on women receiving transcatheter aortic valve implantation (TAVI). The outcome revealed that Edwards SAPIEN 3 or SAPIEN 3 Ultra valves have led to superior outcomes for women compared with those receiving surgical aortic valve replacement (SAVR).

The latest development will strongly boost the company’s Transcatheter Aortic Valve Replacement (TAVR) and Surgical Structural Heart (Surgical) product groups.

Importance of Edwards’ New Clinical Findings

Women have often been underrepresented in the diagnosis and treatment of severe aortic stenosis. The landmark study provides important insights into their treatment options, with both the transcatheter and surgical arms achieving remarkable results.The RHEIA Trial, which was investigator-initiated and supported by Edwards, was conducted across 48 sites in 12 European countries.

In the evaluation of composite one-year endpoints, TAVI was found to be superior to SAVR with 8.9% of TAVI patients experiencing death, stroke, or rehospitalization compared with the 15.6% in the SAVR cohort. The independently-run RHEIA Trial included 443 female patients with an average age of 73, randomized to TAVI or SAVR to investigate outcomes of Edwards TAVI compared with surgery in an all-comers female patient population suffering from severe symptomatic aortic stenosis.

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Per Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart emphasized the importance of this high-quality clinical research in helping patients decide about the treatment of their heart valve failure. He stated that the success of the TAVI group points to the importance of valve selection for women undergoing aortic valve replacement, especially those with small annuli, to preserve their options for a future valve-in-valve procedure, ensuring the lifetime management of their disease.

EW’s Prospects in the TAVI Market

Per an Allied Market Research report, the global TAVI market was valued at $638.1 million in 2022 and is expected to witness a compound annual growth rate of 14% by 2030.

The market growth is majorly driven by an increase in the prevalence of aortic stenosis, a rise in demand for various TAVI procedures, and technological advancements. In addition, the rise in geriatric population fuels the TAVI market growth, since aged individuals are more susceptible to aortic stenosis.

Major Updates in Edwards’ TAVR and Surgical Businesses

In July 2024, Edwards signed a definitive agreement to acquire JenaValve Technology — a pioneer in the transcatheter treatment of aortic regurgitation. Building on its 2016 investment, the company also exercised its option to acquire Endotronix — a leader in heart failure management solutions. These investments are expected to strengthen its leadership in structural heart innovation and represent long-term growth opportunities.

Additionally, Edwards’ strategy to advance structural heart innovation is also bolstered by the decision to sell its Critical Care product group. In June 2024, the company entered into a definitive agreement with Becton, Dickinson and Company in an all-cash transaction for $4.2 billion. It expects the sale to be completed by the end of the third quarter of 2024.

In May 2024, Edwards’ SAPIEN 3 Ultra RESILIA valve made its European debut. It features the RESILIA tissue’s breakthrough anti-calcification technology, designed to address one of the primary causes of reintervention following heart valve replacement, and potentially extends the durability of the valve.

EW Stock Price Performance

In the past year, shares of EW have lost 8.4% against the industry’s growth of 11%.

EW’s Estimate Trend and EPS Surprise

In the past 30 days, estimates for Edwards’ 2024 earnings decreased 0.4% to $2.70 per share. The company beat estimates in each of the trailing four quarters, the average surprise being 0.8%.

Zacks Rank and Top MedTech Stocks

Edwards currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Exact Sciences (EXAS - Free Report) , AxoGen (AXGN - Free Report) and SiBone (SIBN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Exact Sciences’ shares have plunged 27.6% in the past year. Estimates for the company’s loss per share have improved from $1.14 to 95 cents in 2024 and from 19 cents to 6 cents in 2025 in the past 30 days. EXAS’ earnings beat estimates in three of the trailing four quarters and matched in one, delivering an average surprise of 56.2%. In the last reported quarter, it posted an earnings surprise of 75.7%.

Estimates for AxoGen’s 2024 loss per share have narrowed to 1 cent from 19 cents in the past 30 days. Shares of the company have surged 108.7% in the past year compared with the industry’s growth of 10.9%. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%.

Estimates for SiBone’s 2024 loss per share have narrowed to 89 cents from 95 cents in the past 30 days. Shares of the company have lost 26.5% in the past year against the industry’s 11% growth. SIBN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.4%. In the last reported quarter, it delivered an earnings surprise of 15.4%.

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