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FDA Approvals Could Drive Edwards Lifesciences’ Growth


Sep. 5 2017, Updated 12:35 p.m. ET

Recent approvals and launches

Edwards Lifesciences (EW) had a strong performance in the first half of fiscal 2017. The company expects to continue its growth momentum on the back of a number of key product approvals and launches.

On June 5, 2017, Edwards Lifesciences’ Sapien 3 valve was approved by the FDA (U.S. Food & Drug Administration) for use in the aortic and mitral valve-in-valve procedure. The company has seen tremendous growth in the demand for Sapien 3 recently and expects to see more growth going forward.

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Sapien 3 Ultra and Centera valves are the two key product innovations the company expects to launch in late 2017. Sapien 3 Ultra includes a next-generation sheath technology and an on-balloon delivery system. Edwards Lifesciences expects the European launch of the product in the second half of 2017. For more, read Edwards Lifesciences Focuses on Launch of SAPIEN 3 Ultra and CENTERA Valves.

Product pipeline

EW’s Inspiris Resilia valve was approved by the FDA on July 5, 2017. The device received a CE Mark in September 2016. Currently, it is the only TAVR (transcatheter aortic valve replacement) compliant valve available on the market, thus providing a competitive advantage. The device is expected to be launched in Europe and Japan by the end of 2017. Major competitors of Edwards Lifesciences include Medtronic (MDT), Abbott Laboratories (ABT), and Boston Scientific (BSX), which have recently been trying to gain higher market share in the TAVR market.

Another key product in the company’s Structural Heart segment is the Intuity Elite valve system, which was approved by the FDA in August 2016. For more, read Can Edwards Intuity Elite Boost Edwards Lifesciences’ Revenues?

Edwards Lifesciences is also set to roll out its HemoSphere monitoring platform and disposables under its Critical Care monitoring business.

For exposure to Edwards Lifesciences’ growth while diversifying the company-specific risks, investors can consider investing in the Vanguard Mid-Cap Growth ETF (VOT). VOT has approximately 1.4% of its total holdings in EW.


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