Edwards Lifesciences' (EW) SAPIEN 3 TAVR Receives FDA Nod

Edwards Lifesciences Corporation EW recently announced FDA approval for expanding the use of its flagship SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to treat severe, symptomatic aortic stenosis (AS) patients who face a low risk of open-heart surgery.

The SAPIEN 3 TAVR's (transcatheter aortic valve replacement) low-risk approval was based on remarkable outcomes on AS patients, after being treated with the SAPIEN 3 TAVR. Notably, the TAVR with SAPIEN 3 system has been proved to be a preferred line of treatment over surgery.

For investors’ notice, this FDA approval covers the SAPIEN 3 and SAPIEN 3 Ultra valves in all sizes. The approval is expected to enable all patients suffering from severe AS to be considered for treatment on TAVR, according to their individual preferences and anatomical considerations.

 

Sapien 3 TAVR in Focus

The Edwards SAPIEN 3 transcatheter heart valve system is required for use in symptomatic patients with severe aortic stenosis requiring aortic valve replacement.

It is encouraging to note that Edwards Lifesciences is planning a commercial introduction of its SAPIEN 3 Ultra in Europe, which is estimated to account for a major portion of TAVR sales in Europe by 2019-end.

Further, in the last reported quarter, the company saw strong TAVR adoption driven by SAPIEN 3 in Japan. In fact, sales in the TAVR product group rose 16% year over year.

Other Approvals

Of late, Edwards Lifesciences has been receiving a few crucial regulatory approvals, which are expected to boost its overall cardiac care segment.

In May, the FDA approved the CLASP IIF, a prospective, multicenter, randomized, controlled pivotal trial. It was a clinical study designed to examine the safety and efficacy of the transcatheter mitral valve repair with the Edwards PASCAL system.

Earlier this year, the company announced that the Edwards PASCAL transcatheter valve repair system has attained CE Mark for the treatment of patients with mitral regurgitation.

Market Prospects

Per Grand View Research, the global aortic valve replacement devices market reached a worth of $5.81 billion in 2017. It is anticipated to see a CAGR of 11.1% over the 2018-2025 period. Hence this FDA approval is well-timed.

Price Performance

We believe such positive developments will provide cushion to the stock which has rallied 55.8% compared with the industry’s fall of 3.1% in a year’s time.

Zacks Rank & Key Picks

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

A few better-ranked stocks in the broader medical space are Medtronic MDT, Baxter BAX and NuVasive Corporation NUVA, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is expected to be 7.13%.

Baxter’s long-term earnings growth rate is projected at 12.8%.

NuVasive’s long-term earnings growth rate is expected to be 12.75%.

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