Edwards Lifesciences' CE Mark For SAPIEN 3 Boosts THVT Arm

Widening the Transcatheter Heart Valve Therapy (THVT) product suite, Edwards Lifesciences Corporation (NYSE:EW) recently announced the receipt of CE Mark for the SAPIEN 3 Ultra system for transcatheter aortic valve replacement in patients with severe and symptomatic aortic stenosis. The company plans a controlled launch including training of the SAPIEN 3 Ultra system in Europe in order to ensure high procedural success.

Built with the advantages of the Edwards SAPIEN valves along with the company’s expertise, the SAPIEN 3 Ultra system features an on-balloon delivery system and next-generation sheath technology. However, the SAPIEN 3 Ultra system is not approved for commercial sale in the United States. The company initially expected to receive FDA approval for the same around the end of 2018.

Management also informed about its inability to immediately launch the SAPIEN 3 Ultra system in Germany due to a preliminary injunction that Boston Scientific Corporation (NYSE:BSX) has implemented in the country. However, a full hearing will be held by the German court on the merits of the dispute in mid-2019, where Edwards Lifesciences is expecting a win.

Market Potential

Taking the huge growth potential of the transcatheter heart valve market into consideration, the recent CE Mark for the SAPIEN 3 Ultra system is strategic. Per Persistence Market Research report, the global heart valve repair and replacement market is likely to reach a worth of $3,767.0 million in 2020, at a CAGR of 8.7%.

THVT in Focus

The THVT segment includes technologies designed to treat heart valve diseases using catheter-based approaches, opposed to open surgical techniques. In the third quarter, the company reported THVT sales growth in low teens year over year. Despite certain supply disruptions, growth was driven by excellent clinical performance by SAPIEN 3 as well as continued strong therapy implementation across all regions.

Further, Edwards Lifesciences is aiming at fortifying its position in Europe with the launch of CENTERA valve, which received CE Mark in February. The company continues to see strong TAVR therapy adoption in Japan on SAPIEN 3.

Share Price Movement

Edwards Lifesciences has been gaining investor confidence on consistently positive results. Over a year’s time, the company’s share price has outperformed its industry. The stock has soared 36.8% compared with the industry’s 12.9% rally.

Zacks Rank & Key Picks

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

A few better-ranked stocks in the broader medical space are Stryker Corporation (NYSE:SYK) and Veeva Systems (NYSE:VEEV) .

Stryker has a long-term expected earnings growth rate of 10% and a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Veeva Systems’ long-term earnings growth rate is estimated at 19.3%. The stock carries a Zacks Rank #2.

Will You Make a Fortune on the Shift to Electric Cars?

Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.

With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.

It's not the one you think.

See This Ticker Free >>