The battle for leadership in the transcatheter aortic valve replacement market is going to heat up in 2014.
That’s because Medtronic will launch its CoreValve TAVR system sooner than expected and that will bring it in direct competition with Irvine, California-based Edwards Lifesciences. Since Nov. 2011, Edwards has been the lone company to have an approved, commercially-available TAVR device in the U.S. - Sapien. Transcatheter aortic valve replacement is aimed at patients whose aortic valves are severely blocked but who are too sick to undergo the more-risky open heart surgery to replace those valves.
Last week at the Transcatheter Cardiovascular Therapies conference in San Francisco, Medtronic provided results of a clinical study that showed that CoreValve was quite effective in treating patients who were considered at extreme risk for open heart intervention.
In fact, it wasn’t only efficacious, it also beat clinical results of Sapien. Analyst Glenn Novarro, senior analyst at RBC Capital Markets, wrote in a note during the conference that results were better on several fronts:
CoreValve’s major stroke rate was 4.1% at 1 year following the implantation, compared with 4.6% with Sapien; 4.5% Sapien XT, the as-yet unapproved lower profile TAVR valve from Edwards. Even paravalvular leaks, the other complication associated with the device, was markedly lower in patients using Medtronic’s CoreValve, the results showed.
All this means that hospitals will have another device to choose from when the FDA approves the device.
And here is the other piece of news from Medtronic.
The Minnesota device maker said the product will launch CoreValve in the U.S. at the end of its 2014 fiscal year, which ends at the end of April. In other words, the device is going to be rolled out a full year ahead of Wall Street’s expectation, Novarro noted.
Medtronic said that FDA is going to conduct a separate review of the product as it relates to extreme risk patients and strong risk patients thereby expediting review, and also not require an FDA advisory panel recommendation.
“As it relates to EW, the sooner-than-expected approval will likely lead to MDT taking more US market share than the street previously modeled,” Novarro concluded.
The question is whether hospitals will see lower prices as competition heats up, but Novarro doesn't expect that to happen any time soon.
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