Stroke Prevention For TAVR – And, Perhaps, Beyond
Although TAVR-related stroke rates have been diminishing, it remains a devastating complication of the procedure. Two companies with devices to deflect or collect emboli are embarking on IDE trials that they hope will make cerebral embolic protection a standard of care in TAVR and perhaps other cardiac surgeries, as it already is in carotid artery stenting.
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Clinical trials of transcatheter aortic valve technologies once again dominated news coming out of the Transcatheter Cardiovascular Therapeutics conference, held this year in San Francisco, October 10–15. But the meeting also featured new coronary stent technologies and new information on percutaneous heart pumps to support patients during difficult interventions.
The market opportunity for TAVR is significant, with 2013 sales totaling $303.4 million in the US and $765 million outside the US, and those numbers are expected to grow to an estimated $1.29 billion and $1.63 billion, respectively, by 2018. Edwards and Medtronic dominate the worldwide market at present, but other companies are expected to make inroads with next-generation devices designed to optimize outcomes.
Studies suggest transcatheter aortic valve replacement is associated with a higher stroke risk than standard surgical valve replacement, presumably due to embolic debris released during the TAVR procedure. To address this concern, several companies are developing TAVR-specific embolic protection devices, and their success may prove to be a key driver of future growth in this $1+ billion market.