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

This article was originally published in The Gray Sheet

Executive Summary

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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New TAVI Head-To-Head: Sapien XT Vs. Surgery-Superior CoreValve

Edwards Lifesciences will bring its next-generation transcatheter aortic valve implant (TAVI) system, Sapien XT to the U.S. just in time to face the growing threat of competition from Medtronic’s CoreValve, which earned an expanded FDA indication for patients at high risk for surgery.

Medtronic Will Pay Edwards More Than $1 Billion To Settle TAVR Dispute

A settlement between the two companies dismissing all pending patent litigation related to transcatheter valve replacement technologies ends years of legal wrangling and ensures that the U.S. TAVR market will have at least two competitors.

TAVR Gets Love, MitraClip Gets None In Medicare Inpatient Proposal

CMS proposes to grant new hospital inpatient payment categories for transcatheter valve replacements, a potential boon to Edwards’ and Medtronic’s devices. But the Medicare agency continues to stand firm against upgrading payment levels for Abbott’s MitraClip percutaneous mitral valve repair procedure.

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