New Products In Brief
This article was originally published in The Gray Sheet
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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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.
The device maker says its Tendril STS and IsoFlex Optim pacing leads can be used in patients who need to undergo MRI scans.
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.