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Edwards Begins US CENTERA Study, Reintroduces Valve in Europe


Edwards Lifesciences Corporation EW recently announced the commencement of a study on the company’s self-expanding CENTERA transcatheter valve. The company has started a U.S. pivotal trial on CENTERA for severe, symptomatic aortic stenosis (AS) patients who are at intermediate risk of open-heart surgery.

Under this prospective single-arm, multi-center study, Edwards plans to enroll approximately 1,000 patients and include bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at one year.

Edwards expects successful execution of this study to create a robust body of evidence to support the use of CENTERA for the treatment of patients with aortic stenosis.

Edwards also confirmed that it is recommencing the commercial introduction of the CENTERA valve in Europe after making certain minor modification to CENTERA's delivery system, announced earlier. This is likely to boost the company's core Transcatheter Heart Valves (THV) segment.

CENTERA's Progress So Far

In February, CENTERA valve received CE Mark for use in severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The CE Mark was based on the CENTERA-EU trial results. The outcome of the trial demonstrated high survival rates (99%), low rates of disabling stroke (2.5%) and new permanent pacemaker (4.9%) at 30 days.

The company claims that the valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorized delivery system.

The CENTERA valve is not approved for commercial sale in the United States.

THV in Focus

The THV segment includes technologies designed to treat heart valve diseases using catheter-based approaches as opposed to open surgical techniques.

In the last reported quarter, the company reported THVT sales growth of 20% over the prior-year quarter. In the United States, growth was driven by excellent clinical performance by SAPIEN 3 as well as continued strong therapy implementation across all regions.

Outside the United States, the procedure growth rate was in mid-teens with contributions from all regions. Edwards Lifesciences aims at fortifying its position in Europe with the launch of CENTERA valve. The company is also on track with its plans to receive CE Mark and FDA approval for SAPIEN 3 Ultra in 2018. Edwards Lifesciences continues to see strong TAVR therapy adoption in Japan driven by SAPIEN 3.

Market Potential

As per Persistence Market Research report, the global heart valve repair and replacement market is projected to reach $3,767.0 million in 2020 at a CAGR of 8.7%.

Share Price

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 33.8% compared with the industry’s 21.2%.

Zacks Rank & Key Picks

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

Some other top-ranked stocks in the broader medical space are Intuitive Surgical ISRG, Amedisys, Inc. AMED and Masimo Corporation MASI.

Intuitive Surgical’s long-term expected earnings growth rate is 14.7%. The stock currently carries a Zacks Rank of 2.

Amedisys’ long-term expected earnings growth rate is 19.4%. The stock holds a Zacks Rank #2 at the moment. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Masimo’s long-term expected earnings growth rate is 14.8%. The stock has a Zacks Rank #2 at present.

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