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ACC Results Recap Part I: Low-Risk TAVR Trials Bring Good News For Edwards And Medtronic; Apple Watch Detects AFib In Apple Heart Study

Executive Summary

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the first of three special Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including presentations on Medtronic and Edwards Lifesciences’ transcatheter aortic valves and Apple’s Apple Watch, which now has electrocardiography capabilities.

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Cardiovascular Sales & Earnings Roundup: Medtronic TAVR Disappoints While Abbott And Boston Scientific See Structural Success In 2019

The top five cardiovascular device companies, as ranked by Medtech Insight’s MTI 100, have reported their sales and earnings for the last quarter of the calendar year 2019. Here are the highlights from the most recent presentations from Medtronic, Abbott Laboratories, Boston Scientific, Edwards Lifesciences and Terumo.

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.

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.

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