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Edwards Lifesciences (EW) Debuts SAPIEN 3 Ultra RESILIA Valve

Edwards Lifesciences Corporation EW recently launched the SAPIEN 3 Ultra RESILIA valve post the FDA approval of the same. The SAPIEN 3 Ultra RESILIA valve comprises the breakthrough RESILIA tissue technology and the market-leading SAPIEN 3 Ultra transcatheter aortic heart valve.

The latest launch builds on the company’s leadership in tissue technology. It combines the improvements in tissue science with the SAPIEN 3 Ultra valve to provide the only dry storage transcatheter heart valve in the United States. It will also likely bolster Edwards Lifesciences’ transcatheter aortic valve replacement (TAVR) business.

The SAPIEN 3 Ultra RESILIA valve is anticipated to be available in the United States through a limited release during the fourth quarter of 2022. The commercial opportunity related to this approval is taken into account in Edwards Lifesciences’ 2022 financial expectations.

More on the SAPIEN 3 Ultra RESILIA Valve

The RESILIA tissue is a bovine pericardial tissue that has been treated with advanced anti-calcification technology. It serves as the platform for the company’s new class of valves, including the next-generation SAPIEN X4 valve, currently undergoing clinical trials. At five years, the RESILIA tissue demonstrated freedom from structural valve deterioration.

The RESILIA tissue delivers significant improvements to the SAPIEN 3 Ultra platform, including enhanced calcium blocking properties and dry tissue packaging conditions. It bears the potential to enhance the durability of the SAPIEN 3 Ultra RESILIA valve. It is also used in the Edwards INSPIRIS RESILIA valve.

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Per management, the SAPIEN 3 Ultra RESILIA valve represents the company’s continued focus on innovation to meet patients’ current and future needs, enabling them to live longer, healthier and more productive lives.

Industry Prospects

Per a report by GlobeNewswire, the global aortic valve replacement market is expected to see a CAGR of 14% from 2022 to 2030. Factors such as the increasing prevalence of valvular diseases like aortic stenosis and aortic regurgitation and several technological advancements in the heart valve market can be attributed to market growth.

Given the market prospects, Edwards Lifesciences latest launch seems strategic.

Other Notable Developments

In August 2022, Edwards Lifesciences gained CE Mark for its PASCAL Precision transcatheter valve repair system used to treat mitral and tricuspid regurgitation. The PASCAL Precision system is one of several transcatheter repairs or replacement therapies under development by Edwards Lifesciences to address mitral and tricuspid valve diseases. The novel system treats mitral or tricuspid regurgitation through a single delivery system while facilitating precise navigation and implant delivery.

In March 2022, the company received FDA approval for the MITRIS RESILIA valve, a tissue valve replacement intended particularly for the heart's mitral position. The MITRIS RESILIA valve features a saddle-shaped sewing cuff that resembles the asymmetric shape of the native mitral valve. Its low-profile frame prevents obstruction of the left ventricular outflow tract by stent posts and is visible under fluoroscopy, allowing potential transcatheter interventions for patients in the future.

Share Price Performance

The stock has outperformed its industry in the past year. It has lost 19.5% compared with the 26.8% fall of the industry.

Zacks Rank and Key Picks

Currently, Edwards Lifesciences carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. AMN, ShockWave Medical, Inc. SWAV and McKesson Corporation MCK.

AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has lost 4.6% against the industry’s 32.6% fall.

ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.

ShockWave Medical has outperformed its industry in the past year. SWAV has gained 30.4% against the industry’s 26.8% fall over the past year.

McKesson has an estimated long-term growth rate of 10.1%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2 (Buy).

McKesson has outperformed its industry in the past year. MCK has gained 78.4% against the industry’s 10.5% fall.


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