Edwards Lifesciences' CE Mark For CENTERA Boosts THVT Arm
Zacks Investment Research | Feb 15, 2018 09:54PM ET
Edwards Lifesciences Corporation (NYSE: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 Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.