Medtronic CoreValve Meets Targets In Extreme-Risk Group; Panel Will Not Be Needed, FDA Says
This article was originally published in The Gray Sheet
The firm now expects to gain approval for the extreme-risk indication of its transcatheter aortic heart valve months earlier than earlier predicted following well-received pivotal trial data reported last week at the Transcatheter Cardiovascular Therapeutics meeting.
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Medtronic launched new sizes of its repositionable transcatheter aortic valve replacement system. It also recently reported data for its first-generation CoreValve showing a benefit in high risk patients who had previously undergone coronary artery bypass surgery.
Five-year follow-up data on Edwards’ Sapien and two-year data on Medtronic’s CoreValve presented at the TCT conference in Washington, D.C., show sustained efficacy and safety for transcatheter aortic valves in patients too ill for surgery.
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