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Edwards Lifesciences Corp.

www.edwards.com

Latest From Edwards Lifesciences Corp.

Class I Recall On Edwards Sapien 3 Ultra Valve System

An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.

Recalls Cardiology

FDA Expands TAVR Indication To Low-Risk Patients

As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.

Approvals Clinical Trials

Edwards Discontinues Centera TAVR Program As Sapien Sales Continue To Climb

Edwards Lifesciences is giving up on the Centera transcatheter aortic valve replacement (TAVR), despite promising clinical results, to focus on its Sapien TAVR line. The company reported overall revenue of $1.1bn in the second quarter of 2019, representing 14% year-over-year growth, driven by 18% growth in sales of Sapien systems.

Sales & Earnings Companies

Global Device Approvals Snapshot: 9-15 July 2019; MitraClip G4, Relievion, RAPID Imaging, ExAblate Neuro

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 9-15 July was another slow one for US FDA approvals, with no new PMAs, panel-track PMA supplements, or de novos. Informa’s Meddevicetracker reported three non-US approvals during the week.

Approvals Innovation
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