Transcatheter aortic valve replacement (TAVR) has emerged as one of the most promising new cardiovascular device markets, and it is successfully penetrating a segment of the aortic stenosis population not well-served by current surgical therapies. (See Also see "Transcatheter Valves At The Tipping Point" - Medtech Insight, 26 April, 2013..) Over the past 10 years, more than 50,000 TAVR procedures in over 40 countries have been performed in patients deemed too high risk for surgical aortic valve replacement (SAVR), according to an article in the March/April 2013 issue of Cardiology in Review (Tang et al). However, despite advances in TAVR technology and experience, periprocedural stroke remains a major concern.
In Edwards Lifesciences Corp.’s landmark PARTNER trial (investigating the company’s Sapien TAVR device), and in more recently released data, evidence has been documented on the release of embolic debris and potential cerebrovascular events during TAVR
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