TAVR Update: Edwards Delays European Launch Of Sapien 3 Ultra; New Medtronic CoreValve Data

Edwards originally predicted the Sapien 3 Ultra transcatheter aortic valve would hit the European market this quarter, but the company is now pushing that back to later in 2018 to wait for data from a small single-arm multicenter trial in intermediate-risk patients. In other TAVR news, long-term data supporting Medtronic's CoreValve line of TAVR systems was featured at the recent American College of Cardiology meeting.

Core Valve In Situ
Medtronic CoreValve Transcathter Aortic Valve • Source: Medtronic

Edwards Lifesciences Corp. has launched a 30-patient single-arm study of its next-generation Sapien 3 Ultra balloon-expandable transcatheter aortic valve system, which will push the expected European launch of the system to later in 2018.

In its Feb. 1 fourth-quarter 2017 earnings call, Edwards predicted that the Sapien 3 Ultra, which has a taller outer valve-skirt than the market-leading Sapien 3 valve, would earn a CE mark in the first quarter of 2018 and enter the US market by the end of the year. On March 21, Edwards announced it is projecting the system will reach both Europe and the US later in 2018

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