Edwards Lifesciences Corp (EW), Medtronic, Inc. (MDT): Recent Aortic Valve Events that You Should Understand

It’s difficult to say just how far Medtronic’s CoreValve sales are digging into Edwards’ piece of the TAVR pie. The company hasn’t presented sales figures of the device, but its Structural Heart division recorded sales of $272 million for the three months ended Jan. 25, 2013. That includes the CoreValve and several other products. That figure may soon rise based on a recent, and novel decision by EU regulators.

A niche within a niche

Recently, Medtronic, Inc. (NYSE:MDT) won CE Mark approval in the EU for the CoreValve to replace previously implanted bioprosthetic valves that are failing. This is the world’s first valve-in-valve treatment to win regulatory approval. This niche market monopoly could be just what Medtronic needs to pull ahead of Edwards Lifesciences in the TAVR space.

Impending threat

Another threat to Edwards Lifesciences Corp (NYSE:EW)’s dominance of the TAVR market comes from Boston Scientific Corporation (NYSE:BSX) and its Lotus Valve System. The not-yet-approved valves have a patented “Adaptive Seal” designed to prevent leaking, and so far the results have been exciting. Unlike devices from Edwards and Medtronic, the Lotus Valve is repositionable after being fully deployed. This means that surgeons can use a bit of trial-and-error during surgery to be sure they have deployed the device in the best location possible.

Don’t get rattled just yet

If the Boston Scientific device wins approval throughout the EU later this year as the company expects, it could take a bite out of Edwards’ slice of the TAVR pie. Before you go dumping your Edwards shares, there are two important reasons not to get too excited by the Lotus Valves’ early success. Implantation of the device often requires a pacemaker, and in the US the device is still in a Phase 3 clinical trial that is still in its first year.

If you’re considering a long position in Edwards Lifesciences and/or Medtronic, Inc. (NYSE:MDT) based on their TAVR dominance, a little patience could save you a bundle. Implanted valve leakage is strongly associated with patient mortality. I would wait to see if Boston Scientific’s Lotus Valve continues to show such impressive results in larger clinical trials. If it does, I suggest scaling back or exiting a long position in Edwards Lifesciences Corp (NYSE:EW).

Cory Renauer has no position in any stocks mentioned. The Motley Fool owns shares of Medtronic.

The article Recent Aortic Valve Events that You Should Understand originally appeared on Fool.com.

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