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New Products In Brief

This article was originally published in The Gray Sheet

Executive Summary

Japanese authority approves St. Jude’s MRI-safe pacemaker and Edwards’ Sapien XT, the first transcatheter aortic valve approved in that country. More new products.

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Medtronic’s CoreValve Makes Strides In Japan And U.S.

The Japanese regulatory authority has approved Medtronic’s CoreValve transcatheter aortic valve based on data from the CoreValve Japan trial and U.S. trial data. Meanwhile, FDA granted CoreValve its first TAVR approval for a "valve-in-valve" indication for patients with prior replacements.

St. Jude Expands Pacing Leads For MRI Use In Europe

The device maker says its Tendril STS and IsoFlex Optim pacing leads can be used in patients who need to undergo MRI scans.

Edwards Reports TAVR Sales Progress In U.S. And Abroad

Edwards Lifesciences reported 19 percent year-over-year growth in worldwide sales of its Sapien transcatheter aortic valve systems during the second quarter of 2014. The company cites the ongoing launch of the Sapien 3 system in Europe and Sapien XT in the U.S. as keys to continuing growth.

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