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Edwards Lifesciences SAPIEN XT: Fresh FDA Nod for TAVR

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Renowned heart valve manufacturer Edwards Lifesciences Corp. 's EW SAPIEN XT valve recently won the U.S. Food and Drug Administration (FDA) approval for its use in valve-in-valve transcatheter aortic valve replacement (TAVR) procedure. The device is already available in the U.S. and Europe for performing conventional TAVR in high-risk aortic stenosis patients.

We believe this approval will induce higher sales for Edwards' transcatheter heart valve (THV) in the U.S. market, wherein the company already enjoys a leading position. Investors naturally seem quite pleased with this latest development, as is evident from the 4.8% rise in Edwards' share price following the news release.

Notably, the minimally invasive valve-in-valve TAVR procedure is a more suitable alternative for patients who are at high risk of undergoing open-heart surgeries to replace their failed bioprosthetic valves. Unlike in standard surgeries, the valve-in-valve procedure does not require the removal of the old, damaged valve. In fact, it is a fairly new technique that has been lately recognized by the FDA to treat high-risk patients with symptomatic aortic stenosis.

In this context, we note that before SAPIEN XT's approval, Medtronic plc's MDT CoreValve system was the only other transcatheter heart valve sanctioned by the FDA for valve-in-valve TAVR. Medtronic had received the regulatory nod for CoreValve in Mar 2015. The go-ahead for SAPIEN XT thus offers Edwards a competitive leverage in the billion-dollar TAVR market, further consolidating its position as one of the top players in this space.

Further, in order to demonstrate SAPIEN XT's clinical efficacy, the company recently released one-year positive study results from its PARTNER II valve-in-valve registry. According to this data, 86.6% patients survived at one-year while only 3.7% suffered a stroke. Moreover, at 30 days, a remarkable 100% survival rate was demonstrated by the patients.

Per management, this trial outcome successfully demonstrates the clinical superiority of SAPIEN XT as a safe therapeutic alternative to open-heart surgery for high-risk patients, who need their tissue valves replaced.

Management at Edwards is positive about strong demand for its heart valves, even in the face of tough competition, in the globally expanding THV market. This, in turn, should boost sales for the company.

Moreover, with the global TAVR market expected to grow at a CAGR of 19.7% during 2013-2020, we expect the recent FDA approval for SAPIEN XT to help Edwards capture a larger share in this space. Additionally, increasing therapy awareness, a trend among physicians referring more patients for TAVR, continued positive data and favorable clinical experience for the product should further strengthen Edwards' position in the TAVR market.

Currently, Edwards has a Zacks Rank #4 (Sell). Some better-ranked medical instruments stocks are Masimo Corporation MASI , EDAP TMS SA EDAP and Cesca Therapeutics Inc. KOOL . All the three stocks sport a Zacks Rank #1 (Strong Buy).

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MEDTRONIC (MDT): Free Stock Analysis Report

EDWARDS LIFESCI (EW): Free Stock Analysis Report

MASIMO CORP (MASI): Free Stock Analysis Report

EDAP TMS SA-ADR (EDAP): Free Stock Analysis Report

CESCA THERAP (KOOL): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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