Edwards Lifesciences' CE Mark for CENTERA Boosts THVT Arm

Edwards Lifesciences Corporation EW announced the receipt of CE Mark for its self-expanding CENTERA valve. The valve is used for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. However, the CENTERA valve is not approved for commercial sale in the United States.

Per the company, the Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system.

The CE Mark was based on the CENTERA-EU Trial results, which were presented at EuroPCR 2017. This study enrolled 203 high-risk patients at 23 centers in Europe, Australia and New Zealand. The outcome of the trial demonstrated high survival rates (99%) and low rates of disabling stroke (2.5%) and new permanent pacemaker (4.9%) at 30 days.

 

 

The regulatory approval is likely to boost the company's Transcatheter Heart Valves (THV) segment precisely.

THV in Focus

THV segment includes technologies designed to treat heart valve diseases using catheter-based approaches as opposed to open surgical techniques. In the fourth quarter, the company reported THV sales growth of 20.2% over the prior-year quarter, with double-digit procedure growth in Europe. The latest development is likely to further enhance the company’s prospects in Europe.

Outside the United States, the underlying growth rate was 22% with contributions from all regions. Of late, Edward Lifesciences has witnessed multiple developments in its THV segment. Edwards Lifesciences announced the receipt of FDA approval for aortic and mitral valve-in-valve procedures, using SAPIEN 3 transcatheter heart valve in June. Management released positive patient outcomes of SAPIEN 3 valve, including high survival rates and low rates of stroke and paravalvular leak.

Market Potential

Taking into consideration the huge growth potential of the THV market, the recent CE Mark for CENTERA valveis strategic. As per Persistence Market Research report, the global heart valve repair and replacement market is projected to reach a worth $3,767.0 million in 2020, at a CAGR of 8.7%.

Share Price & Estimate Revision Trend

Edwards Lifesciences has been gaining investor confidence on consistently positive results. Over the last year, the company’s share price has outperformed the industry. The stock has gained 50.1% compared with the industry’s 22.8%.

The current estimate revision trend is favorable. For the current year, 11 estimates moved north compared with no movement in the opposite direction over the last month. As a result, the Zacks Consensus Estimate for the full year has risen 7.9% to $4.49 per share.

Zacks Rank and Other Key Picks

Edwards Lifesciences carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the broader medical sector are PerkinElmer PKI, Bio-Rad Laboratories BIO and Becton, Dickinson and CompanyBDX.

Bio-Rad Laboratories has a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.The company has a long-term expected earnings growth rate of 25%.

PerkinElmer has a long-term expected earnings growth rate of 12.3%. The stock carries a Zacks Rank #2.

Becton, Dickinson and Company has a Zacks Rank #2. The company has a long-term expected earnings growth rate of 13.3%.

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