Posts Tagged ‘TAVR’

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March 30th, 2014

First TAVR Comparison Trial Favors Sapien XT Over CoreValve

With two devices now approved for transcatheter aortic valve replacement (TAVR), the marketing battle has begun to win the hearts and minds of cardiologists. On Saturday at the ACC, Medtronic gained bragging rights showing the first mortality benefit for its CoreValve device. A similar improvement did not occur in the PARTNER trials with the Edwards […]


March 29th, 2014

TAVR: Are You Impressed Now?

Interventionalist Ajay Kirtane offers his perspective on the new randomized trial comparing transcatheter (CoreValve) with surgical aortic valve replacement.


March 29th, 2014

Survival Advantage for TAVR Over Surgery in High-Risk Patients

Transcatheter aortic valve replacement (TAVR), which has been slowly and cautiously entering the clinical arena, will probably get a big boost from a new trial showing a significant mortality advtange for TAVR over traditional surgery. Results from the U.S. CoreValve High-Risk Study were presented at the American College of Cardiology in Washington, DC, and published simultaneously […]


March 13th, 2014

Achieving Consensus for the 2014 ACC/AHA Valvular Heart Disease Guideline

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The writing committee co-chairs of the 2014 ACC/AHA Valvular Heart Disease Guideline discuss how the committee achieved consensus on the future treatment of valvular disease.


March 3rd, 2014

New Guidelines Issued for Valvular Heart Disease

The American Heart Association and the American College of Cardiology today released new practice guidelines for the management of patients with valvular heart disease (VHD). Among its most notable features, the new document provides a new system of classification for VHD and lowers the threshold for interventions, including, for the first time, transcatheter as well […]


February 21st, 2014

Unpacking a Systematic Review of TAVR Research

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Philip Green and Kumar Dharmarajan explore how best to identify which patients benefit most from transcatheter aortic valve replacement.


January 20th, 2014

FDA Grants Earlier Than Expected Approval for Medtronic’s CoreValve

The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. The approval was based largely on results from the Extreme Risk Study of the CoreValve […]


October 29th, 2013

Pivotal Results for Medtronic’s CoreValve

Key data on what will likely be the second transcatheter aortic valve to gain approval in the U.S. were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open […]


September 23rd, 2013

Using Registry Data, FDA Expands Indication for Edwards’ Sapien Transcatheter Heart Valves

Relying on an important new source of information, the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously, the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points […]


July 12th, 2013

Medtronic Faces Removal of CoreValve Transcatheter Heart Valve from German Market

In the wake of a major patent decision, Medtronic will be forced to remove its CoreValve transcatheter heart valve from the German market. Edwards Lifesciences said today that a German Court had found that Medtronic infringed a key patent, known as the Spenser patent, and granted an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany. Medtronic said it would appeal the […]