TCT 2013: Higher pacemaker rate marks difference between Medtronic's, Edwards Lifesciences' TAVI devices

October 28, 2013 by Arezu Sarvestani

A retrospective analysis reports near-identical outcomes for transcatheter aortic valve implantation systems by medtech rivals Medtronic and Edwards Lifesciences, but Edwards' Sapien tallies a win for its corner with fewer patients requiring permanent pacemakers following TAVI.

TCT 2013: Researchers find few differences between CoreValve and Sapien outcomes

Results from the PRAGMATIC Plus analysis of Edwards Lifesciences' (NYSE:EW) Sapien transcatheter aortic valve implantation system and Medtronic's (NYSE:MDT) rivaling CoreValve device found few differences between the devices, with the exception of lower rates of permanent pacemaker implantation in patients who received Edwards' Sapien device.

The so-called "pacemaker issue" has been a recurring topic at healthcare conferences since 1st publication earlier this year in the Journal of the American College of Cardiology, although the problem isn't considered a safety risk.

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"Importantly, there is no association between pacemaker implants and increased mortality, while other complications – such as stroke, PVL, rupture, and vascular complications – are much more worrisome because they can be dangerous and even life-threatening for patients," Medtronic told today.