Edwards Lifesciences' INSPIRIS RESILIA Valve Wins FDA Nod

Global major in patient-focused innovation for structural heart disease and critical care monitoring, Edwards Lifesciences Corporation (NYSE:EW) is making constant efforts to expand its Surgical Heart Valve Therapy business. The company recently announced the receipt of FDA approval for its INSPIRIS RESILIA aortic valve.

The approval came on the heels of favorable data from the COMMENCE pivotal trial. Per the study, two-year data on 689 patients showed no cases of structural valve deterioration, valve thrombosis or nonstructural valve dysfunction.

INSPIRIS RESILIA aortic valve is a first-of-its-kind resilient heart valve. The valve contains a breakthrough tissue technology that delivers the combination of enhanced anti-calcification properties, improved sustained hemodynamic performance and dry storagenamed RESILIA tissue.

Another feature which lends an edge to the INSPIRIS valve is its VFit technology. The technology incorporates fluoroscopically visible size markers and is designed for potential valve-in-valve procedures. Also, the INSPIRIS valve is a trusted valve platform which is built on the proven performance of the Carpentier-Edwards PERIMOUNT valve design.

The valve is expected to be launched in the U.S. in early 2018. According to Research and Markets, the Global Heart Valve Devices Market is expected to see a CAGR of 13.35% during 2016-2021.

Over the past three months, Edwards Lifesciences has been trading above the Zacks categorized Medical - Instruments industry. The stock has gained 28.0%, much higher than the industry’s gain of 9.9%.

Recent Developments

The INSPIRIS RESILIA aortic valve was commercially launched in Europe earlier this year. The company also intends to launch the valve in Japan later this year.

On comparing INTUITY Elite valve system with the conventional full sternotomy aortic valve replacements, it was found that INTUITY procedures had a lower overall length of stay, cross-clamp time and OR time which resulted in reduced costs. The study also showed lower instances of 30-day mortality, stroke and re-operation.

Zacks Rank & Key Picks

Edwards Lifesciencescurrently carries a Zacks Rank #2 (Buy).Other top-ranked medical stocks are Mesa Laboratories, Inc. (NASDAQ:MLAB) , Inogen, Inc. (NASDAQ:INGN) and Align Technology, Inc. (NASDAQ:ALGN) . Notably, Mesa Laboratories and Inogen sport a Zacks Rank #1 (Strong Buy), while Align Technology carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Mesa Laboratories has a positive earnings surprise of 2.84% over the last four quarters. The stock has added roughly 10.9% over the last three months.

Inogen has a long-term expected earnings growth rate of 17.5%. The stock has gained around 25.6% over the last three months.

Align Technology has an expected long-term adjusted earnings growth of almost 24.1%. The stock has added roughly 31.9% over the trailing three months.

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